DELTA ABUTMENT SYSTEM
Instructions for use
These instructions show indications, contraindications, warnings and methods of use of the Delta Abutments system.
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.
Delta Abutment System’s intended use is to successfully complete dental prostheses restoration processes in the clinical or laboratory environment.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Table.1 Information about components of Delta Abutment System
Class according MDD CE 93/42
Stainless steel 304 L
Stainless steel 304 L
Open tray transfer
Closed tray transfer
Rotary Interface 0,5mm
Code expressed with letter R refers to the compatible connection shown in table.2
Table.2 Compatibility references naming
compatible with 3i Certain 3.4
compatible with 3i Certain 4.1
compatible with 3i Certain 5.0
compatible with 3i Externa 3.4
compatible with 3i Externa 4.1
compatible with 3i Externa 5.0
compatible with Adin Interna 3.5
compatible with Astra Tech Yellow
compatible with Astra Tech Aqua
compatible with Astra Tech Lilac
compatible with Astra Evo 3.6
compatible with Astra Evo 4.2
compatible with Astra Evo 4.8
compatible with Astra Evo 3.0
compatible with Astra Evo Multiunit
compatible with Astra Pilar 20º
compatible with Astra Pilar 45º
compatible with Avinent Externa 3.5
compatible with Avinent Externa 4.0
compatible with Avinent Interna 3.5
compatible with Avinent Interna 4.0
compatible with Bego Interna 3.75
compatible with Bego Interna 4.5
compatible with BioHorizons Interna 3.0
compatible with BioHorizons Interna 3.5
compatible with BioHorizons Interna 4.5
compatible with BioHorizons Interna 5.7
compatible with BioHorizons Externa 3.5
compatible with BioHorizons Externa 4.0
compatible with BioHorizons Externa 5.0
compatible with BioHorizons Externa 6.0
compatible with BTI Externa 3.5
compatible with BTI Externa 4.1
compatible with BTI Externa 5.5
compatible with BTI Interna 3.5
compatible with BTI Interna 4.0
compatible with BTI Interna 5.5
compatible with BTI Unit 4.0
compatible with BTI Unit 5.5
compatible with Mis Interna NARROW
compatible with Mis Interna 3.75
compatible with Mis Interna 4.5
compatible with Mis Interna 5.7
compatible with Mis Multiunit
compatible with Mis Multiunit Angulado
compatible with Nobel Active NP
compatible with Nobel Active RP
compatible with Nobel Branemark NP
compatible with Nobel Branemark RP
compatible with Nobel Branemark WP
compatible with Nobel Multiunit RP
compatible with Nobel Multiunit WP
compatible with Nobel Replace NP
compatible with Nobel Replace RP
compatible with Nobel Replace WP
compatible with Nobel Replace 6.0
compatible with Straumann Bone Level NC
compatible with Straumann Bone Level RC
compatible with Straumann Tissue Level RN
compatible with Straumann Tissue Level WN
compatible with Straumann Pilar Tissue Level RN
compatible with Straumann Pilar Tissue Level WN
compatible with Straumann Pilar Bone level
compatible with Sweden Martina Externa 3.3
compatible with Sweden Martina Externa 4.1
compatible with Sweden Martina Externa 5.0
compatible with Sweden Martina Kohno 3.3
compatible with Sweden Martina Kohno 3.8
compatible with Sweden Martina Kohno 4.25
compatible with Sweden Martina Kohno 5.0
compatible with Zimmer TSV Green
compatible with Zimmer TSV Purple
compatible with Zimmer TSV Yellow
compatible with Dentsply Xive 3.4
compatible with Dentsply Xive 3.8
compatible with Dentsply Xive 4.5
compatible with Dentsply Xive TG 4.8
compatible with Camlog Interna 3.8
compatible with Eckermann Interna 4.3
compatible with Galimplant Interna
compatible with Galimplant Pilar Recto Rotatorio
compatible with Galimplant Pilar Recto Antirrotatorio
compatible with Galimplant Externa 4.0
compatible with Galimplant Externa 5.0
compatible with Implant Direct Legacy 3.0
compatible with Klockner Essential 4.5
compatible with Klockner Essential 6.0
compatible with Klockner Octa 4.5
compatible with Klockner Octa 6.0
compatible with Klockner SK2 3.3
compatible with Klockner SK2 4.2
compatible with Klockner SK2 5.5
compatible with Klockner Vega MV
compatible with Klockner Vega NV
compatible with Klockner Vega RV
compatible with Klockner SH
compatible with Megagen Anyridge 3.3
compatible with Megagen Anyridge 3.75
compatible with Megagen Octa 3.8
compatible with Megagen Octa 4.8
compatible with Megagen Octa 5.8
compatible with Neodent CM Interna
compatible with Neodent GM Interna 4.8
compatible with Neodent CM Pilar 3.5
compatible with Neodent CM Pilar AR
compatible with Neodent CM Pilar RO
compatible with Neodent GM Pilar Micro
compatible with Neodent GM Pilar Mini
compatible with Neodent Externa 3.3
compatible with Neodent Externa 4.3
compatible with Neodent Externa 5.1
compatible with OXY Multiunit 5.0
compatible with Phibo Aurea Evo 3.5
compatible with Phibo Aurea Evo 4.3
compatible with Phibo Aurea Evo 5.4
compatible with Phibo TSA S3
compatible with Phibo TSA S4
compatible with Phibo TSA S5
compatible with Phibo TSH S2
compatible with Phibo TSH S3/S4
compatible with Phibo TSH S5
compatible with Phibo ConHex 4.75
compatible with Samo Interna 4.2
compatible with Anthogyr Axiom BL 2.8
compatible with Anthogyr Axiom BL
compatible with Anthogyr Axiom TL
compatible with Anthogyr Axiom MultiLevel
compatible with Ziacom Interna 4.0
compatible with Ziacom Interna 5.0
compatible with Ziacom Externa 3.3
compatible with Ziacom Externa 4.0
compatible with Ziacom Externa 5.0
compatible with Ziacom Zinic NP
compatible with Ziacom Zinic RP
compatible with Ziacom Zinic WP
compatible with JD Evolution S
compatible with JD Evolution
compatible with JD Evolution Plus+
compatible with JD Icon UltraS
compatible with Microdent Genius 3.0
compatible with Microdent Genius 3.5
compatible with Microdent Genius 4.0
compatible with Microdent Genius 4.5
compatible with Microdent Genius 5.0
compatible with Microdent System 3.5
compatible with Microdent System 4.2
compatible with Microdent System 5.1
compatible with Microdent System 5.6
compatible with Microdent Universal 3.5
compatible with Microdent Universal 4.1
compatible with Microdent Universal 5.1
compatible with Microdent Universal 5.6
compatible with Microdent Trylogic 3.8
compatible with Microdent Trylogic 4.3
compatible with Microdent Trylogic 5.1
compatible with Microdent Trylogic 5.5
compatible with Microdent EK 3.5
compatible with Microdent EK 4.5
compatible with Microdent EK 5.7
compatible with GMI Frontier RP
compatible with GMI Frontier WP
compatible with GMI Phoenix Estrecha
compatible with GMI Phoenix Estándar
compatible with GMI Phoenix Ancha
compatible with GMI Phoenix Extra-Ancha
compatible with GMI Avantgard RP
compatible with GMI Avantgard WP
compatible with GMI Monolith
compatible with TBR Infinity 3.5
compatible with TBR Infinity 4.0
compatible with TBR Infinity 5.0
compatible with TBR Infinity Z1 3.5
compatible with TBR Infinity Z1 4.0
compatible with TBR Infinity Z1 5.0
compatible with Paltop Internal Hex Narrow
compatible with Paltop Internal Hex Standard
compatible with Paltop Internal Hex Wide
compatible with Paltop Conical
compatible with Radhex Interna IS
compatible with Radhex Interna IM
compatible with Radhex Externa ES
compatible with Radhex Externa EM
compatible with Intralock Gold&Blue Gs
compatible with Intralock Gold&Blue Gw
compatible with Intralock InDex Estrecho
compatible with Intralock InDex Estándar
compatible with Intralock InDex Ancha
compatible with Intralock IntraHex 3.5
compatible with Intralock IntraHex 4.5
compatible with Intralock UniHex
compatible with Intralock Flatone 3.5
compatible with Intralock Flatone 5..0
compatible with Alpha Bio IH 3.75/4.2/5.0
compatible with Alpha Bio CHC NIce
compatible with Alpha Bio CHC Ice
compatible with Mozo Grau Inhex Mini
compatible with Mozo Grau Inhex STD
compatible with Mozo Grau Osseus Mini
compatible with Mozo Grau Osseus STD
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.