Elos Accurate Hybrid Base

K230317 · Elos Medtech Pinol A/S · NHA · Sep 1, 2023 · Dental

Device Facts

• Record ID: K230317
• Device Name: Elos Accurate Hybrid Base
• Applicant: Elos Medtech Pinol A/S
• Product Code: NHA · Dental
• Decision Date: Sep 1, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Elos Accurate® Hybrid Base™ is intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Hybrid Base™ is used as an interface between a dental implant and a zirconia superstructure and will be attached to the implant using a prosthetic screw and attached to the zirconia superstructure by cementing. The Elos Accurate® Hybrid Base™ is compatible with the implant systems listed in table 1: [Table 1 omitted for brevity]. The zirconia superstructures for use with the Elos Accurate® Hybrid Base™ are either intended to be sent and manufactured at an FDA registered Elos Medtech approved milling facility or to be designed and manufactured according to digital dentistry workflow system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories.

Device Story

Elos Accurate® Hybrid Base™ is a two-piece dental abutment system; consists of a titanium alloy base and a patient-specific zirconia superstructure. Used by dental clinicians and laboratories to restore chewing function. Input: digital scan data from intra-oral scanners. Transformation: CAD software (3Shape Abutment Designer™) uses digital library files with predefined design limits (min wall thickness 0.5mm, max angulation 20°) to design the superstructure; CAM software and milling units manufacture the zirconia component. Output: final assembled abutment/superstructure unit. The base is attached to the implant via a prosthetic screw; the zirconia top is cemented to the base. The device is delivered non-sterile; requires sterilization at the clinic before placement. Benefits include patient-specific esthetic restoration and compatibility with various implant platforms. The system ensures design integrity by preventing users from exceeding validated design limits within the software.

Clinical Evidence

Bench testing only. Evidence includes fatigue testing per ISO 14801, dimensional analysis for implant compatibility, and sterilization validation (ISO 17665-1/2, SAL 10^-6). Biocompatibility evaluated per ISO 10993-1/5 (cytotoxicity testing). Digital workflow validated using 3Shape scanner, 3Shape Abutment Designer (K151455), and CORiTEC milling unit. MR Conditional status leveraged from K222044.

Technological Characteristics

Materials: Ti-6Al-4V alloy (ASTM F136) for abutment/screw; 3M Lava Zirconia for superstructure. Two-piece design; gold-colored anodized surface. Connectivity: Digital library files (DME) for CAD/CAM integration. Sterilization: Non-sterile, requires clinic-based sterilization. Software: Rule-based design limits enforced by 3Shape Abutment Designer.

Indications for Use

Indicated for patients requiring single or multiple tooth prosthetic restorations supported by dental implants. Compatible with specific Zimmer, Biomet 3i, Straumann, Neodent, and Hiossen implant platforms.

Regulatory Classification

Identification

An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

Special Controls

*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)

Predicate Devices

• Elos Accurate® Hybrid Base™ (K201860)

Reference Devices

• Elos Accurate® Hybrid Base™ (K191919)
• Elos Accurate® Customized Abutment (K222044)
• ZimmerBiomet (K013227)
• ZimmerBiomet (K122300)
• JJGC Industria e Comercio de Materiais Dentarios SA (K163194)
• JJGC Industria e Comercio de Materiais Dentarios SA (K180536)
• JJGC Industria e Comercio de Materiais Dentarios SA (K201225)
• Hiossen Inc. (K140934)
• Hiossen Inc. (K153332)
• Institut Straumann AG (K150938)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "U.S. Food & Drug Administration" in blue.

Elos Medtech Pinol A/S Lise Terkelsen Regulatory Affairs Professional Engvei 33 Goerloese, 3330 DENMARK

Re: K230317

Trade/Device Name: Elos Accurate® Hybrid Base™ Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA, PNP Dated: August 4, 2023 Received: August 7, 2023

Dear Lise Terkelsen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Andrew I. Steen -S

Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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#### Traditional 510(k) Premarket Notification: Elos Accurate® Hybrid Base™ CONFIDENTIAL Elos Medtech Pinol A/S

## INDICATIONS FOR USE

510(k) Number: K230317 Device Name: Elos Accurate® Hybrid Base™

The Elos Accurate® Hybrid Base™ is intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Hybrid Base™ is used as an interface between a dental implant and a zirconia superstructure and will be attached to the implant using a prosthetic screw and attached to the zirconia superstructure by cementing.

The Elos Accurate® Hybrid Base™ is compatible with the implant systems listed in table 1:

| Implant Platform compatibility | Platform diameter<br>[mm] | Implant Body diameter<br>[mm] |
|--------------------------------|---------------------------|--------------------------------|
| Zimmer Screw-vent 3.5 | Ø3.5 | Ø3.7/Ø4.1 |
| Zimmer Screw-vent 4.5 | Ø4.5 | Ø4.7 |
| Zimmer Screw-vent 5.7 | Ø5.7 | Ø6.0 |
| Biomet 3i Certain 3.4 | Ø3.4 | Ø3.25 |
| Biomet 3i Certain 4.1 | Ø4.1 | Ø4 |
| Biomet 3i Certain 5.0 | Ø5 | Ø5 |
| Biomet 3i Certain 6.0 | Ø6 | Ø6 |
| Straumann Standard RN | Ø4.8 | Ø3.3/Ø4.1/Ø4.8 |
| Straumann Standard WN | Ø6.5 | Ø4.8 |
| Neodent GM | Ø3.5/Ø4.5/Ø5.5/Ø 6.5 | Ø3.5/Ø3.75/Ø4/Ø4.3/Ø 5/Ø 6/Ø 7 |
| Hiossen ET Mini | Ø3.2/Ø3.5 | Ø3.2/Ø3.5 |
| Hiossen ET Regular | Ø4/Ø4.5/Ø5/ Ø5.5/Ø6/Ø7 | Ø4/Ø4.5/Ø5/ Ø5.5/Ø6/Ø7 |

#### Table 1.

The zirconia superstructures for use with the Elos Accurate® Hybrid Base™ are either intended to be sent and manufactured at an FDA registered Elos Medtech approved milling facility or to be designed and manufactured according to digital dentistry workflow system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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## K230317

## 510(k) Summary Elos Accurate® Hybrid BaseTM Aug. 315, 2023

This summary of 510(k) information is being submitted in accordance with the requirements of 21 CFR § 807.92.

| I. Company: | Elos Medtech Pinol A/S<br>Engvej 33<br>DK-3330 Goerloese<br>Denmark |
|-----------------------------|---------------------------------------------------------------------|
| Contacts: | Lise Terkelsen<br>Regulatory Affairs Professional |
| | Tel: [phone] |
| | E-mail: [e-mail] |
| | Søren Rangstrup |
| | Manager of Product Development & Regulatory Affair |
| | Tel: [phone] |
| | E-mail: [e-mail] |
| II. Proprietary Trade Name: | Elos Accurate® Hybrid Base™ |
| III. Classification Name: | Endosseous Dental Implant Abutment |
| IV. Classification: | Class II, 21 CFR 872.3630 |
| V. Product Code(s): | Primary: NHA |
| | Secondary: PNP |

#### VI. Identification of Legally Marketed Devices:

The design features, materials and Indications for Use of the subject devices are substantially equivalent to the predicate devices noted below.

#### Primary Predicate Device:

- K201860 / SE 02/19/2021 Elos Accurate® Hybrid Base™ .
#### Reference Devices:

- K191919 / SE 02/10/2020 Elos Accurate® Hybrid Base™ ●
- K222044 / SE 30/11/2022 Elos Accurate® Customized Abutunent .
- K013227 / SE 19/11/2001 ZimmerBiomet ●
- K122300 / SE 30/01/2013 - ZimmerBiomet
- K 163194 / SE 14/07/2014 JJGC Industria e Comercio de Materiais Dentarios SA .
- K180536 / SE 30/08/2018 JJGC Industria e Comercio de Materiais Dentarios SA ●

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- . K201225 / SE 09/04/2020 - JJGC Industria e Comercio de Materiais Dentarios SA
- K140934 / SE 11/12/2014 - Hiossen Inc.
- . K153332 / SE 27/10/2016 - Hiossen Inc.
- K150938 / SE 24/07/2015 - Institut Straumann AG

#### VII. Product Description:

The Elos Accurate® Hybrid Base™ is intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Hybrid Base™ is used as an interface between a dental implant and a zirconia superstructure and will be attached to the implant using the included prosthetic screw and attached to the zirconia superstructure by cementing. The Elos Accurate® Hybrid Base™ is a two-piece abutment composed of the Hybrid Base as the bottomhalf and the zirconia superstructure as the top-half, which when assembled comprises the final finished medical device.

The Elos Accurate® Hybrid Base™ consists of a pre-manufactured prosthetic component in Titanium alloy per ASTM F136, as well as supporting digital library file for 510(k) cleared design software (3Shape Abutment Designer™ Software, K151455) which facilitates the design of a patient specific zirconia superstructure by the laboratory/clinician. The Elos Accurate® Hybrid Base™ fits directly to an endosseous dental implant. The laboratory designed superstructure is manufactured from 510(k) cleared Zirconia (Lava Plus, K011394) according to digital dentistry workflow. For all Elos Accurate® Hybrid Base™ models the zirconia superstructure must be designed according to following limits:

- 1) Minimum wall thickness 0.5 mm
- 2) Minimum post height 4.0 mm (for single unit restorations)
- 3) Maximum gingival height 5.0 mm (min. GH of 0.5mm)
- 4) Maximum angulation 20°

The laboratory designed superstructure is attached to the Elos Accurate® Hybrid Base by use of 510(k) cleared cement (Multilink Hybrid Abutment, K130436 or Panavia V5, K150704) and the final prosthetic restoration is attached to the implant using a Prosthetic screw.

The Elos Accurate® Hybrid Bas has a gold-colored anodized surface to increase the esthetics of the dental restoration - the same surface as in predicate device K201860.

Some of the prosthetic screws are uncoated and two screws are Medicarb coated, identical to the Medicarb coating in predicate device K201860. The subject uncoated screws are compatible with implant platforms Zimmer Screw-vent, Biomet 3i, Neodent GM and Straumann Standard RN and WN. The subject Medicarb coated screws are compatible with the implant platforms Hiossen ET Mini and ET Regular. The purpose of the coating is to lower friction in the thread connection and the screw seat connection.

The Elos Accurate® Hybrid Base™ is delivered non-sterile and the final restoration and corresponding screw is intended to be sterilized at the dental clinic before it is placed in the patient.

## VIII. Indications for Use:

The Elos Accurate® Hybrid Base™ is intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Hybrid Base™ is used as an interface

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between a dental implant and a zirconia superstructure and will be attached to the implant using a prosthetic screw and attached to the zirconia superstructure by cementing. The Elos Accurate® Hybrid Base™ is compatible with the implant systems listed in table 1:

| Table 1. | | |
|-----------------------------------|---------------------------|--------------------------------|
| Implant Platform<br>compatibility | Platform diameter<br>[mm] | Implant Body diameter<br>[mm] |
| Zimmer Screw-vent 3.5 | Ø3.5 | Ø3.7/Ø4.1 |
| Zimmer Screw-vent 4.5 | Ø4.5 | Ø4.7 |
| Zimmer Screw-vent 5.7 | Ø5.7 | Ø6.0 |
| Biomet 3i Certain 3.4 | Ø3.4 | Ø3.25 |
| Biomet 3i Certain 4.1 | Ø4.1 | Ø4 |
| Biomet 3i Certain 5.0 | Ø5 | Ø5 |
| Biomet 3i Certain 6.0 | Ø6 | Ø6 |
| Straumann Standard RN | Ø4.8 | Ø3.3/Ø4.1/Ø4.8 |
| Straumann Standard<br>WN | Ø6.5 | Ø4.8 |
| Neodent GM | Ø3.5/Ø4.5/Ø5.5/Ø 6.5 | Ø3.5/Ø3.75/Ø4/Ø4.3/Ø 5/Ø 6/Ø 7 |
| Hiossen ET Mini | Ø3.2/Ø3.5 | Ø3.2/Ø3.5 |
| Hiossen ET Regular | Ø4/Ø4.5/Ø5/<br>Ø5.5/Ø6/Ø7 | Ø4/Ø4.5/Ø5/Ø5.5/Ø6/Ø7 |

The zirconia superstructures for use with the Elos Accurate® Hybrid Base™ are either intended to be sent and manufactured at an FDA registered Elos Medtech approved milling facility or to be designed and manufactured according to digital dentistry workflow. The workflow system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories.

#### IX. Summary of the Technological Characteristics:

The subject devices provide additional restorative options for connection to existing implant platforms. The subject devices have similar Indications for Use, intended use, designs, sizes and configurations, materials, and principles of operation as the predicate devices. In order to determine nominal dimensions and tolerances of the Elos Accurate® Hybrid Base™ products, measuring- and dimensional analyses of original manufacturers' components (abutments, implants & abutment screws) have been made.

Comparing to the primary predicate device, the specific language (wording) of the Indications for Use Statements is equivalent except for implant system compatibility and the approach for finalizing the zirconia superstructures. The implant system compatibility of the subject device is extended to include compatibility to the Hiossen, Neodent, Zimmer, Biomet and Straumann implant system platforms. The difference in implant system compatibility is substantiated by engineering and dimensional analysis of original manufactures' components (abutments, implants & abutment screws) for determination of compatibility and new fatigue testing.

The approach of designing and manufacturing the zirconia superstructure for the subject device is either according to a digital dentistry workflow (identical to Primary Predicate Device K201860) or to be sent and manufactured at an FDA registered Elos Medtech approved milling facility (identical

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to Reference Device K191919). The subject device does not represent any new worst case, and is thereby covered by existing workflow validation submitted in K201860, except the additional new digital libraries were validated as part of the subject submission, which included following:

- Scanner: 3Shape scanner (accuracy >10μm)

- Design library file (DME-file) provided by Elos Medtech which includes design limits in accordance with "Instruction For Use"

- Design Software: 3Shape Abutment Designer Software (K151455)

- Zirconia Material: 3M Lava Plus Zirconia (K011394)

- Milling Unit: CORiTEC, imes-icore milling unit

- Adhesive material: Multilink Hybrid Abutment Cement, Ivoclar Vivadent AG (K130436) or Panavia V5 by KURARAY NORITAKE DENTAL (K150704)

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| Indications for Use<br>Subject Device | | Indications for Use<br>Primary Predicate Device (201860) | | Indications for Use<br>Reference Device (K191919) | | Discussion | | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|-------------------------------------|
| Elos Accurate® Hybrid Base™ | | Elos Accurate® Hybrid Base™ | | Elos Accurate® Hybrid Base™ | | | | |
| The Elos Accurate® Hybrid Base™ is intended for<br>attaching to dental implants in order to provide basis for<br>single or multiple tooth prosthetic restorations. The<br>Hybrid Base™ is used as an interface between a dental<br>implant and a zirconia superstructure and will be<br>attached to the implant using a prosthetic screw and<br>attached to the zirconia superstructure by cementing.<br>The Elos Accurate® Hybrid Base™ is compatible with<br>the implant systems listed in table 1: | | The Elos Accurate® Hybrid Base™ is intended for<br>attaching to dental implants in order to provide basis for<br>single or multiple tooth prosthetic restorations. The<br>Hybrid Base™ is used as an interface between a dental<br>implant and a zirconia superstructure and will be<br>attached to the implant using a prosthetic screw and<br>attached to the zirconia superstructure by cementing.<br>The Elos Accurate® Hybrid Base™ is compatible with<br>the implant systems listed in table 1: | | The Elos Accurate® Hybrid Base™ is intended for<br>attaching to dental implants in order to provide basis for<br>single or multiple tooth prosthetic restorations. The<br>Hybrid Base™ is used as an interface between a dental<br>implant and a zirconia superstructure and will be<br>attached to the implant using a prosthetic screw and<br>attached to the zirconia superstructure by cementing.<br>The Elos Accurate® Hybrid Base™ is compatible with<br>the implant systems listed in table 1: | | The Indication for use for the subject device is<br>similar to the Primary Predicate Device (K201860)<br>and Reference Device (K191919), beside table 1.<br>which have been extended with 5 new implant<br>systems, and the approach for finalizing the<br>zirconia superstructure have been merged for the<br>Primary Predicate Device (K201860) and<br>Reference Device (K191919) so the zirconia<br>superstructure either can be manufactured at a<br>FDA registered Elos Medtech approved milling<br>facility or to be designed and manufactured<br>according to digital dentistry workflow.<br><br>The difference in implant system compatibility is<br>substantiated by engineering and dimensional<br>analysis of original manufactures' components<br>(abutments, implants & screws) for determination<br>of compatibility and new fatigue testing. | | |
| Table 1. | | Table 1. | | Table 1. | | | | |
| Implant<br>Platform<br>compatibility | Platform<br>diameter<br>[mm] | Implant<br>Body<br>diameter<br>[mm] | Implant Platform<br>compatibility | Platform<br>diameter<br>[mm] | Implant<br>Body<br>diameter<br>[mm] | Implant Platform<br>compatibility | Platform<br>diameter<br>[mm] | Implant<br>Body<br>diameter<br>[mm] |
| Zimmer | 03.5 | 03.7/04.1 | Nobel Replace NP | 3.5 | 3.5 | Nobel Replace NP | 3.5 | 3.5 |
| Zimmer | 04.5 | 04.7 | Nobel Replace RP | 4.3 | 4.3 | Nobel Replace RP | 4.3 | 4.3 |
| Zimmer | 05.7 | 06.0 | Nobel Replace WP | 5 | 5 | Nobel Replace WP | 5 | 5 |
| Biomet 3i | 03.4 | 03.25 | Nobel Replace 6.0 | 6 | 6 | Nobel Replace 6.0 | 6 | 6 |
| Biomet 3i | 04.1 | 04 | Nobel CC 3.0 | 3 | 3 | Nobel CC 3.0 | 3 | 3 |
| Biomet 3i | 05 | 05 | Nobel CC NP | 3.5 | 3.5 & 3.75 | Nobel CC NP | 3.5 | 3.5 & 3.75 |
| Biomet 3i | 06 | 06 | Nobel CC RP | 3.9 | 4.3 & 5 | Nobel CC RP | 3.9 | 4.3 & 5 |
| Straumann | 04.8 | 03.3/04.1/04.8 | Nobel CC WP | 5.1 | 5.5 | Nobel CC WP | 5.1 | 5.5 |
| Straumann | 06.5 | 04.8 | Straumann Bone | 3.3 | 3.3 | Straumann Bone | 3.3 | 3.3 |
| Neodent GM | 03.5/04.5/05.5/0<br>6.5 | 03.5/03.75/04/04.3/0<br>5/0 6/0 7 | Straumann Bone | 4.1 & 4.8 | 4.1 & 4.8 | Straumann Bone | 4.1 & 4.8 | 4.1 & 4.8 |
| Hiossen ET<br>Mini | 03.2/03.5 | 03.2/03.5 | Astra Tech 3.0 | 3 | 3 | Astra Tech 3.0 | 3 | 3 |
| Hiossen ET<br>Regular | 04/04.5/05/<br>05.5/06/07 | 04/04.5/05/<br>05.5/06/07 | Astra Tech 3.5/4.0 | 3.5 & 4 | 3.5 & 4 | Astra Tech 3.5/4.0 | 3.5 & 4 | 3.5 & 4 |
| | | | Astra Tech 4.5/5.0 | 4.5 & 5 | 4.5 & 5 | Astra Tech 4.5/5.0 | 4.5 & 5 | 4.5 & 5 |
| | | | Astra Tech EV 3.0 | 3 | 3 | Astra Tech EV 3.0 | 3 | 3 |
| | | | Astra Tech EV 3.6 | 3.6 | 3.6 | Astra Tech EV 3.6 | 3.6 | 3.6 |
| | | | Astra Tech EV 4.2 | 4.2 | 3.6 & 4.2 | Astra Tech EV 4.2 | 4.2 | 3.6 & 4.2 |
| | | | Astra Tech EV 4.8 | 4.8 | 4.2 & 4.8 | Astra Tech EV 4.8 | 4.8 | 4.2 & 4.8 |
| | | | Astra Tech EV 5.4 | 5.4 | 5.4 | Astra Tech EV 5.4 | 5.4 | 5.4 |
| | | | Brånemark NP | 3.5 | 3.3 | Brånemark NP…