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RSQS-7.3-05-Contenido de las Instrucciones de uso de producto sanitario (ENG)
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DELTA ABUTMENT SYSTEM

Instructions for use

RSQS-7.3-05-IFU

26/05/2021 rv5

Introduction

These instructions show indications, contraindications, warnings and methods of use of the Delta Abutments system.

Warnings

Following warnings apply globally to the whole Delta Abutments System.

In case of doubt please contact the manufacturer.

The product is designed to be single-used. Do not reuse product.

Mechanical properties of a reused product may have been altered and the implant connection damaged.

Sinumetrics Systems can not guarantee the correct performance of a reused product.

Delta Abutments Systems clinical abutments must only be used by odontology professionals specialized in implantology and prosthetics within dental specialized facilities.

If Delta Abutment system is used by non-specialised personnel , possible defects as well as new material reclaim will not be covered by guarantee.

Sinumetrics Systems recommends procedural use of dental product by the customer to guarantee the processes used are performed as intended. These processes include: Inspection of purchased material, surgical planification, cleansing, sterilisation, clinical case review, surgical procedure, systematic review plan and customer complaints among others.

For the correct use of Delta Abutment System it is recommended to use indicated instrumentation.

Intended use

Delta Abutment System’s intended use is to successfully complete dental prostheses restoration processes in the clinical or laboratory environment.

Contraindications

Delta Abutment systems is not intended to be used on patients suffering from allergies or other harmful reactions to materials of the system. Please read carefully table 1 to identify the component meant to be used and the material it’s made of. According to customer protocols, Sinumetrics Systems recommends compiling all the important information about the patient to avoid this potential negative effects.

Some patient’s habits such as dental hygiene and smoking can affect negatively to abutment’s system’s intended use. It is recommended to inform the patient about the importance of healthy dental habits.

Compatibility with other products

Delta Abutment system is designed and tested so it’s intended use is meant to be used with other products from other brands. Please check table 2 regarding compatibilities and make sure the product that has been planned to be used is suitable for the dental implants the patient is using.

Information regarding cleaning and sterilisation

Cleaning

Cleaning is performed by Sinumetrics Systems. In case the customer needs to perform cleaning according to his or her procedures, it is recommended to use neutral detergent, whether manual or automated cleaning.

Sterilisation

Sinumetrics Systems does not perform Sterilisation to Delta Abutment system. Sinumetrics recommends the following indications to sterilise the medical device (in accordance with standard EN ISO 17665-1:2006):

This processes are validated by outsourced analysis laboratories. Other equivalent sterilization methods can be used as long as they are to be validated by the user according to EN ISO 17665-1:2006 and EN ISO 11607-1:2017.

Products

01-Scanbody-Intended use and indications for use

Intended use of scanbodies is laboratory work model scans to determine dental implant position.

Scanbodies are linked to digital files associated to it’s scanning system. Scanbodies are not intended to be used with the patient. They can only be used with laboratory dental models. Scanbodies must be connected to the analogs of the work model and scan them.It is necessary to check scanbodies correct fitting for accurate scanning. It is highly recommended to check scanbodies wear out. If, due to wear, connection does not fit accordingly, scanning information may be wrong.

02-Analog-Intended use and indications for use

Intended use of analogs is laboratory model creation with the exact position of the analogs where implants should be in mouth. Analog can be reused, however the customer must check no damage has altered the connection. If this is so this can lead to wrong measurements and incorrect prostheses adjustments.

03-Laboratory Screw-Intended use and indications for use

Intended use of the lab screw is the manipulation of the dental prosthesis with ease in the laboratory dental model. The use of this screw is specifically intended to work with restorations which use acrylic resin in prosthesis manufacturing.

04-05-Castable-Intended use and indications for use

Intended use of castable is the manufacturing of prostheses using casting through lost wax technique.

Castable replicates connection and has retention for wax to adhere properly. Casting is a manual process in which several variables intervene. Responsibility for castable use is on the customer.

06-Open tray transfer-Intended use and indications for use

Intended use of open tray transfer is correct transference of the position of the implants from patient’s mouth to a work model.Open tray transfer is indicated to be used in the open tray measuring procedure.

07-Closed tray transfer-Intended use and indications for use

Intended use of closed tray transfer is the correct transference of the position of the implants from patient’s mouth to a work model. Closed tray transfer  is indicated to be used in the closed tray measuring procedure.

08-Implant cap-Intended use and indications for use

Intended use of implant cap is to isolate the connection of the implant from possible damage or contamination during surgical procedure. It is indicated for rehabilitations that use immediate load or measuring techniques and other procedures that may be performed during implant positioning surgery.

09-29-Clinical screw-Intended use and indications for use

The intended use of clinical screw is fixing abutment and prosthesis to the implant. It is recommended to screw the product at the recommended maximum torque indicated in table.3. It is recommended to apply recommended torque and 10 minutes later apply that torque again.

10-Millable abutment-Intended use and indications for use

The intended use of the millable abutment is to create an artificial custom hand-made stump.

It is indicated to perform this procedure as far as possible from the patient. The scrap metal may be harmful to the patient.

11-Temporary abutment-Intended use and indications for use

The intended use of the temporal abutment is to support provisional restorations made in acrylic resin.

To manufacture these restorations the abutment can be milled to desired shape. It is indicated to perform this procedure as far as possible from the patient. The scrap metal may be harmful to the patient.

12-Healing Abutment-Intended use and indications for use

The intended use of the healing abutment is to protect the connection of the implant during implant stability phases of primary and secondary stability. Additionally it’s rounded shape is meant for the gingiva to recover safely. The recommended maximum torque is indicated in table.3. It is recommended to apply recommended torque and 10 minutes later apply that torque again.

13-14-15-Multiunit abutment-Intended use and indications for use

Intended use of the Multiunit abutment is to be used as a base for fixed screw restorations.

The recommended maximum torque is indicated in table.3. It is recommended to apply recommended torque and 10 minutes later apply that torque again.

Product labeling indicates screw metrics, it’s maximum torque recommended for its screw is idicated in table.3.

Additionally, the abutment final restorations has to be screwed with screw REF:090931 which has an M1.4 class thread. The recommended maximum torque for this screw is indicated in table.3.

16-17-18-19-26-38-Interface-Intended use and indications for use

Intended use of the interface is to create an intermediate connection for cemented based restorations. The client must plan the use for these interfaces taking into account which implants are in the patient's mouth and which type of restoration must be crafted, whether it is single or multiple.

20-Locator-Intended use and indications for use

Intended use for locators is anchoring of implant supported bars with removable provisional prosthetics.

Locator has an M2.0 class thread. The recommended maximum torque for this screw is indicated in table.3. Locator comercial name is Delta-Loc.

31-Scanbody-Intended use and indications for use

Intended use of scanbodies is to scan patient’s mouth in order to determine dental implant position.

Scanbodies are linked to digital files associated to it’s scanning system. Scanbodies must be connected to the analogs of the work model and scan them.It is necessary to check scanbodies correct fitting for accurate scanning. It is highly recommended to check scanbodies wear out. If, due to position, connection does not fit accordingly, scanning information may be wrong.

Label indications

  1. Product brand
  2. Reference of the product
  3. LOT number
  4. Manufacturing date
  5. Warnings
  6. Online site for instructions for use
  7. CE marking and Notified body code (0123, TÜV-SÜD)
  8. Symbol indications (non reusable, non sterile. etc.)
  9. Manufacturer and it's address. (Sinumetrics Systems S.A.L. C/Tecnica 75, 08740, Sant Andreu de la Barca, Barcelona, Spain.)
  10. Date of the last revision of the label


Information Tables

Table.1 Information about components of Delta Abutment System

Product

Códe(*)

Class according MDD CE 93/42

Material

Scanbody

01RRRR

N/A

Aluminum

Analog

02RRRR

N/A

Stainless steel 304 L

Laboratory Screw

03RRRR

N/A

Stainless steel 304 L

Rotary Castable

04RRRR

N/A

POM

Anti-Rotary Castable

05RRRR

N/A

POM

Open tray transfer

06RRRR

IIa

Titanium g.V

Closed tray transfer

07RRRR

IIa

Titanium g.V

Implant cap

08RRRR

IIb

Titanium g.V

Clinical screw

09RRRR

29RRRR

IIb

Titanium g.V

Millable abutment

10RRRR

IIb

Titanium g.V

Temporary abutment

11RRRR

22RRRR

IIb

Titanium g.V

Healing Abutment

12RRRR

IIb

Titanium g.V

Multiunit abutment

13RRRR

14RRRR

15RRRR

IIb

Titanium g.V

Rotary Interface 0,5mm

16RRRR

17RRRR

18RRRR

19RRRR

26RRRR

38RRRR

IIb

Titanium g.V

Locator

20RRRR

IIb

Titanium g.V

Scanbody Intraoral

31RRRR

IIa

Titanium g.V

Code expressed with letter R refers to the compatible connection shown in table.2

Table.2 Compatibility references naming

0111

compatible with 3i Certain 3.4

0112

compatible with 3i Certain 4.1

0113

compatible with 3i Certain 5.0

0121

compatible with 3i Externa 3.4

0122

compatible with 3i Externa 4.1

0123

compatible with 3i Externa 5.0

0211

compatible with Adin Interna 3.5

0311

compatible with Astra Tech Yellow

0312

compatible with Astra Tech Aqua

0313

compatible with Astra Tech Lilac

0321

compatible with Astra Evo 3.6

0322

compatible with Astra Evo 4.2

0323

compatible with Astra Evo 4.8

0324

compatible with Astra Evo 3.0

0331

compatible with Astra Evo Multiunit

0341

compatible with Astra Pilar 20º

0342

compatible with Astra Pilar 45º

0411

compatible with Avinent Externa 3.5

0412

compatible with Avinent Externa 4.0

0421

compatible with Avinent Interna 3.5

0422

compatible with Avinent Interna 4.0

0511

compatible with Bego Interna 3.75

0512

compatible with Bego Interna 4.5

0611

compatible with BioHorizons Interna 3.0

0612

compatible with BioHorizons Interna 3.5

0613

compatible with BioHorizons Interna 4.5

0614

compatible with BioHorizons Interna 5.7

0621

compatible with BioHorizons Externa 3.5

0622

compatible with BioHorizons Externa 4.0

0623

compatible with BioHorizons Externa 5.0

0624

compatible with BioHorizons Externa 6.0

0711

compatible with BTI Externa 3.5

0712

compatible with BTI Externa 4.1

0713

compatible with BTI Externa 5.5

0721

compatible with BTI Interna 3.5

0722

compatible with BTI Interna 4.0

0723

compatible with BTI Interna 5.5

0731

compatible with BTI Unit 4.0

0732

compatible with BTI Unit 5.5

0811

compatible with Mis Interna NARROW

0812

compatible with Mis Interna 3.75

0813

compatible with Mis Interna 4.5

0814

compatible with Mis Interna 5.7

0821

compatible with Mis Multiunit

0822

compatible with Mis Multiunit Angulado

0911

compatible with Nobel Active NP

0912

compatible with Nobel Active RP

0921

compatible with Nobel Branemark NP

0922

compatible with Nobel Branemark RP

0923

compatible with Nobel Branemark WP

0931

compatible with Nobel Multiunit RP

0932

compatible with Nobel Multiunit WP

0941

compatible with Nobel Replace NP

0942

compatible with Nobel Replace RP

0943

compatible with Nobel Replace WP

0944

compatible with Nobel Replace 6.0

1011

compatible with Straumann Bone Level NC

1012

compatible with Straumann Bone Level RC

1021

compatible with Straumann Tissue Level RN

1022

compatible with Straumann Tissue Level WN

1031

compatible with Straumann Pilar Tissue Level RN

1032

compatible with Straumann Pilar Tissue Level WN

1041

compatible with Straumann Pilar Bone level

1111

compatible with Sweden Martina Externa 3.3

1112

compatible with Sweden Martina Externa 4.1

1113

compatible with Sweden Martina Externa 5.0

1121

compatible with Sweden Martina Kohno 3.3

1122

compatible with Sweden Martina Kohno 3.8

1123

compatible with Sweden Martina Kohno 4.25

1124

compatible with Sweden Martina Kohno 5.0

1211

compatible with Zimmer TSV Green

1212

compatible with Zimmer TSV Purple

1213

compatible with Zimmer TSV Yellow

1311

compatible with Dentsply Xive 3.4

1312

compatible with Dentsply Xive 3.8

1313

compatible with Dentsply Xive 4.5

1321

compatible with Dentsply Xive TG 4.8

1511

compatible with Camlog Interna 3.8

1612

compatible with Eckermann Interna 4.3

1711

compatible with Galimplant Interna

1721

compatible with Galimplant Pilar Recto Rotatorio

1722

compatible with Galimplant Pilar Recto Antirrotatorio

1731

compatible with Galimplant Externa 4.0

1732

compatible with Galimplant Externa 5.0

1811

compatible with Implant Direct Legacy 3.0

1911

compatible with Klockner Essential 4.5

1912

compatible with Klockner Essential 6.0

1921

compatible with Klockner Octa 4.5

1922

compatible with Klockner Octa 6.0

1931

compatible with Klockner SK2 3.3

1932

compatible with Klockner SK2 4.2

1933

compatible with Klockner SK2 5.5

1941

compatible with Klockner Vega MV

1942

compatible with Klockner Vega NV

1943

compatible with Klockner Vega RV

1951

compatible with Klockner SH

2021

compatible with Megagen Anyridge 3.3

2011

compatible with Megagen Anyridge 3.75

2031

compatible with Megagen Octa 3.8

2032

compatible with Megagen Octa 4.8

2033

compatible with Megagen Octa 5.8

2111

compatible with Neodent CM Interna

2121

compatible with Neodent GM Interna 4.8

2131

compatible with Neodent CM Pilar 3.5

2132

compatible with Neodent CM Pilar AR

2133

compatible with Neodent CM Pilar RO

2141

compatible with Neodent GM Pilar Micro

2142

compatible with Neodent GM Pilar Mini

2151

compatible with Neodent Externa 3.3

2152

compatible with Neodent Externa 4.3

2153

compatible with Neodent Externa 5.1

2211

compatible with OXY Multiunit 5.0

2311

compatible with Phibo Aurea Evo 3.5

2312

compatible with Phibo Aurea Evo 4.3

2313

compatible with Phibo Aurea Evo 5.4

2321

compatible with Phibo TSA S3

2322

compatible with Phibo TSA S4

2323

compatible with Phibo TSA S5

2331

compatible with Phibo TSH S2

2332

compatible with Phibo TSH S3/S4

2333

compatible with Phibo TSH S5

2341

compatible with Phibo ConHex 4.75

2411

compatible with Samo Interna 4.2

2511

compatible with Anthogyr Axiom BL 2.8

2512

compatible with Anthogyr Axiom BL

2521

compatible with Anthogyr Axiom TL

2531

compatible with Anthogyr Axiom MultiLevel

2611

compatible with Ziacom Interna 4.0

2612

compatible with Ziacom Interna 5.0

2621

compatible with Ziacom Externa 3.3

2622

compatible with Ziacom Externa 4.0

2623

compatible with Ziacom Externa 5.0

2631

compatible with Ziacom Zinic NP

2632

compatible with Ziacom Zinic RP

2633

compatible with Ziacom Zinic WP

2711

compatible with JD Evolution S

2712

compatible with JD Evolution

2713

compatible with JD Evolution Plus+

2721

compatible with JD Icon UltraS

2811

compatible with Microdent Genius 3.0

2812

compatible with Microdent Genius 3.5

2813

compatible with Microdent Genius 4.0

2814

compatible with Microdent Genius 4.5

2815

compatible with Microdent Genius 5.0

2821

compatible with Microdent System 3.5

2822

compatible with Microdent System 4.2

2823

compatible with Microdent System 5.1

2824

compatible with Microdent System 5.6

2831

compatible with Microdent Universal 3.5

2832

compatible with Microdent Universal 4.1

2833

compatible with Microdent Universal 5.1

2834

compatible with Microdent Universal 5.6

2841

compatible with Microdent Trylogic 3.8

2842

compatible with Microdent Trylogic 4.3

2843

compatible with Microdent Trylogic 5.1

2844

compatible with Microdent Trylogic 5.5

2851

compatible with Microdent EK 3.5

2852

compatible with Microdent EK 4.5

2853

compatible with Microdent EK 5.7

2911

compatible with GMI Frontier RP

2912

compatible with GMI Frontier WP

2921

compatible with GMI Phoenix Estrecha

2922

compatible with GMI Phoenix Estándar

2923

compatible with GMI Phoenix Ancha

2924

compatible with GMI Phoenix Extra-Ancha

2931

compatible with GMI Avantgard RP

2932

compatible with GMI Avantgard WP

2941

compatible with GMI Monolith

3011

compatible with TBR Infinity 3.5

3012

compatible with TBR Infinity 4.0

3013

compatible with TBR Infinity 5.0

3021

compatible with TBR Infinity Z1 3.5

3022

compatible with TBR Infinity Z1 4.0

3023

compatible with TBR Infinity Z1 5.0

3111

compatible with Paltop Internal Hex Narrow

3112

compatible with Paltop Internal Hex Standard

3113

compatible with Paltop Internal Hex Wide

3121

compatible with Paltop Conical

3211

compatible with Radhex Interna IS

3212

compatible with Radhex Interna IM

3221

compatible with Radhex Externa ES

3222

compatible with Radhex Externa EM

3311

compatible with Intralock Gold&Blue Gs

3312

compatible with Intralock Gold&Blue Gw

3321

compatible with Intralock InDex Estrecho

3322

compatible with Intralock InDex Estándar

3323

compatible with Intralock InDex Ancha

3331

compatible with Intralock IntraHex 3.5

3332

compatible with Intralock IntraHex 4.5

3341

compatible with Intralock UniHex

3351

compatible with Intralock Flatone 3.5

3352

compatible with Intralock Flatone 5..0

3411

compatible with Alpha Bio IH 3.75/4.2/5.0

3421

compatible with Alpha Bio CHC NIce

3422

compatible with Alpha Bio CHC Ice

3511

compatible with Mozo Grau Inhex Mini

3512

compatible with Mozo Grau Inhex STD

3521

compatible with Mozo Grau Osseus Mini

3522

compatible with Mozo Grau Osseus STD

3621

compatible with Dentium Supeprline/Implantum

Please check the reference you plan to use exists before ordering. Check online catalog or contact Sinumetrics Systems. Not all cross references exist for all components.

Table.3 Maximum torque according to M class thread.

M class

Torque [N·cm]

M1.4

15

M1.6

20

M1.8

25

M2.0

30

M2.5

40

Sinumetrics Systems S.A.L.

C/Técnica 75, Sant Andreu de la Barca, 08740 Barcelona, España

tlf: 93 682 37 12