Elos Accurate Customized Abutment

K222044 · Elos Medtech Pinol A/S · NHA · Nov 30, 2022 · Dental

Device Facts

• Record ID: K222044
• Device Name: Elos Accurate Customized Abutment
• Applicant: Elos Medtech Pinol A/S
• Product Code: NHA · Dental
• Decision Date: Nov 30, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Elos Accurate® Customized Abutments are intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Elos Accurate® Customized Abutment will be attached to a dental implant using the included Elos Prosthetic screw. The Elos Accurate® Customized Abutments are compatible with the implant systems listed in Table 1: [Table 1 content omitted for brevity]. All digitally designed CAD/CAM customizations for the Elos Accurate® Customized Abutments are only intended 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, milling machine and associated tooling and accessories.

Device Story

Elos Accurate® Customized Abutment is a patient-specific dental abutment fabricated from Titanium alloy (ASTM F136). Input: digital scan data from intra-oral scanners. Transformation: CAD software (3Shape Abutment Designer) and CAM software (CORiTEC milling unit) process digital designs within pre-set library limitations (e.g., wall thickness, angulation) to mill the abutment blank. Output: customized abutment attached to dental implant via Elos Prosthetic screw. Used in dental clinics/labs by clinicians/technicians. Output provides a stable base for definitive single or multi-unit prosthetic restorations. Benefits include patient-specific fit and restoration of chewing function. Device is MR conditional.

Clinical Evidence

Bench testing only. Evidence includes engineering/dimensional analysis for compatibility, fatigue testing per ISO 14801, biocompatibility (ISO 10993-5), sterilization validation (ISO 17665-1/2), and MRI conditional testing (ASTM F2052, F2119, F2213, F2182). Digital workflow validation confirmed that design library limits prevent user editing outside specified parameters.

Technological Characteristics

Material: Ti-6Al-4V alloy (ASTM F136). Sensing/Actuation: None (mechanical). Energy: None. Dimensions: Platform diameters 3.0-6.0mm; angulation up to 30°. Connectivity: Digital workflow integration (Intra-oral scanner, CAD/CAM). Sterilization: Delivered non-sterile; intended for clinic sterilization. Software: Rule-based design library (DME-file) with hard-coded design limits.

Indications for Use

Indicated for patients requiring single or multiple tooth prosthetic restorations supported by dental implants. Compatible with specific Nobel Replace, Nobel CC, Straumann Bone Level, Astra Tech, and Brånemark implant systems. Intended for use by dental professionals in a clinical setting.

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® Customized Abutment (K190299)
• Elos Accurate® Customized Abutment (K171799)
• Elos Accurate® Customized Abutment (K192457)
• Elos Accurate® Customized Abutment (K191890)

Reference Devices

• Elos Accurate® Hybrid Base (K201860)
• 3Shape Abutment Designer Software (K151455)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

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

November 30, 2022

Re: K222044

Trade/Device Name: Elos Accurate® Customized Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous dental implant abutment Regulatory Class: Class II Product Code: NHA, PNP

Dear Lise Terkelsen:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter issued on November 30, 2022. Specifically, FDA is updating this SE Letter as an administrative correction.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Andrew Steen, OHT : Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices, 301-796-6284, [e-mail].

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

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Image /page/1/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Elos Medtech Pinol A/S Lise Terkelsen Regulatory Affairs Specialist Engvej 33 Goerloese, 3330 DENMARK

Re: K222044

Trade/Device Name: Elos Accurate® Customized Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA, PNP Dated: October 28, 2022 Received: October 31, 2022

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 mediation-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 (DICE(@fda.hhs.gov) 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 Ouality Center for Devices and Radiological Health

Enclosure

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Traditional 510(k) Premarket Notification: Elos Accurate® Customized Abutment Elos Medtech Pinol A/S

## INDICATIONS FOR USE

510(k) Number: K222044 Device Name: Elos Accurate® Customized Abutment

## Indications for Use

The Elos Accurate® Customized Abutments are intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Elos Accurate® Customized Abutment will be attached to a dental implant using the included Elos Prosthetic screw. The Elos Accurate® Customized Abutments are compatible with the implant systems listed in Table 1:

| Table | A<br>- |
|-------|--------|
| | |

| Implant Platform compatibility | Platform diameter [mm] | Implant Body diameter [mm] |
|--------------------------------|------------------------|----------------------------|
| Nobel Replace NP | 3.5 | 3.5 |
| Nobel Replace RP | 4.3 | 4.3 |
| Nobel Replace WP | 5 | 5 |
| Nobel Replace 6.0 | 6 | 6 |
| Nobel CC 3.0 | 3 | 3 |
| Nobel CC NP | 3.5 | 3.5 & 3.75 |
| Nobel CC RP | 3.9 | 4.3 & 5 |
| Nobel CC WP | 5.1 | 5.5 |
| Straumann Bone Level NC | 3.3 | 3.3 |
| Straumann Bone Level RC | 4.1 & 4.8 | 4.1 & 4.8 |
| 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 EV 3.6 | 3.6 | 3.6 |
| 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 5.4 | 5.4 | 5.4 |
| Brånemark NP | 3.5 | 3.3 |
| Brånemark RP | 4.1 | 3.75, 4 & 5 |
| Brånemark WP | 5.1 | 5 & 6 |

All digitally designed CAD/CAM customizations for the Elos Accurate® Customized Abutments are only intended 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, milling machine and associated tooling and accessories.

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

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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## 510(k) Summary Elos Accurate® Customized Abutment November 30, 2022

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 Specialist<br>Tel: [phone]<br>E-mail: [e-mail] | |
| | | Søren Rangstrup<br>Manager of Product Development & Regulatory Affairs<br>Tel: [phone]<br>E-mail: [e-mail] | |
| II. | Proprietary Trade Name: | Elos Accurate® Customized Abutment | |
| III. | Classification Name: | Endosseous Dental Implant Abutment | |
| IV. | Classification: | Class II, 21 CFR 872.3630 | |
| V. | Product Code(s): | NHA as the primary product code<br>PNP as the secondary product code | |

#### 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:

- K 190299 / SE 06/26/2019 Elos Accurate® Customized Abutment ●
- K171799 / SE 01/15/2018 Elos Accurate® Customized Abutment ●
- K 192457 / SE 01/02/2020 Elos Accurate® Customized Abutment ●
- K191890 / SE 02/06/2020 Elos Accurate® Customized Abutment ●

## Reference Devices:

- K201860 / SE 02/19/2021 Elos Accurate® Hybrid Base ●
- K151455 / SE 06/09/2016 3Shape Abutment Designer Software ●

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#### VII. Product Description:

The Elos Accurate® Customized Abutment is a patient specific abutment intended for attaching to dental implants in order to provide basis for single- or multiple tooth prosthetic restorations. The Elos Accurate® Customized Abutment will be attached to the implant using the included Elos Prosthetic Screw and attached to the crown/coping manually by cementation. The Elos Accurate® Customized Abutment consists of an Abuttnent Blank used in fabricating of a full patient-specific abutment in Titanium alloy per ASTM F136. The Abutment Blank used in creation of the Elos Accurate® Customized Abutment has a pre-manufactured connection interface that fits directly to a pre-specified dental implant. The customized shape of the abutment is intended to be manufactured according to a digital dentistry workflow. The Elos Accurate® Customized Abutment is delivered non-sterile and the final restoration including corresponding Elos Prosthetic Screw is intended to be sterilized at the dental clinic before it is placed in the patient. The Elos Accurate® Customized Abutment provides clinicians and laboratories with a prosthetic device that can be used in definitive (permanent) single- or multi restorations.

The Elos Accurate library file has built-in design limitations, and the user isn't allowed to exceed these limitations. The material thickness should not be less than 0.4 or 0.5 mm depend on implant platform compatibility (see Table A). The gingival height should not be less than 0.5mm or exceed 5 mm. The maximum angulation should not exceed 30° or 20° depend on implant platform compatibility (see Table A). The post height should not be less than 4 mm.

| Implant Platform compatibility | Platform<br>diameter [mm] | Max angulation | Min wall thickness |
|--------------------------------|---------------------------|----------------|--------------------|
| Nobel Replace NP | 3.5 | 30° | 0,4 mm |
| Nobel Replace RP | 4.3 | 30° | 0,4 mm |
| Nobel Replace WP | 5 | 30° | 0,4 mm |
| Nobel Replace 6.0 | 6 | 30° | 0,4 mm |
| Nobel CC 3.0 | 3 | 30° | 0,4 mm |
| Nobel CC NP | 3.5 | 30° | 0,4 mm |
| Nobel CC RP | 3.9 | 30° | 0,4 mm |
| Nobel CC WP | 5.1 | 30° | 0,4 mm |
| Straumann Bone Level NC | 3.3 | 30° | 0,4 mm |
| Straumann Bone Level RC | 4.1 & 4.8 | 30° | 0,4 mm |
| Astra Tech 3.5/4.0 | 3.5 & 4 | 30° | 0,4 mm |
| Astra Tech 4.5/5.0 | 4.5 & 5 | 30° | 0,4 mm |
| Astra Tech EV 3.6 | 3.6 | 30° | 0,4 mm |
| Astra Tech EV 4.2 | 4.2 | 30° | 0,4 mm |
| Astra Tech EV 4.8 | 4.8 | 30° | 0,4 mm |
| Astra Tech EV 5.4 | 5.4 | 30° | 0,4 mm |
| Brånemark NP | 3.5 | 20° | 0,5 mm |
| Brånemark RP | 4.1 | 20° | 0,5 mm |
| Brånemark WP | 5.1 | 20° | 0,5 mm |

### Table A.

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#### VIII. Indications for Use:

The Elos Accurate® Customized Abutments are intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Elos Accurate® Customized Abutment will be attached to a dental implant using the included Elos Prosthetic screw.

The Elos Accurate® Customized Abutments are compatible with the implant systems listed in Table 1:

| Table 1. | | |
|-------------------------|------------------------|----------------------------|
| Platform compatibility | Platform diameter [mm] | Implant Body diameter [mm] |
| Nobel Replace NP | 3.5 | 3.5 |
| Nobel Replace RP | 4.3 | 4.3 |
| Nobel Replace WP | 5 | 5 |
| Nobel Replace 6.0 | 6 | 6 |
| Nobel CC 3.0 | 3 | 3 |
| Nobel CC NP | 3.5 | 3.5 & 3.75 |
| Nobel CC RP | 3.9 | 4.3 & 5 |
| Nobel CC WP | 5.1 | 5.5 |
| Straumann Bone Level NC | 3.3 | 3.3 |
| Straumann Bone Level RC | 4.1 & 4.8 | 4.1 & 4.8 |
| 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 EV 3.6 | 3.6 | 3.6 |
| 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 5.4 | 5.4 | 5.4 |
| Brånemark NP | 3.5 | 3.3 |
| Brånemark RP | 4.1 | 3.75, 4 & 5 |
| Brånemark WP | 5.1 | 5 & 6 |

All digitally designed CAD/CAM customizations for the Elos Accurate® Customized Abuments are only intended 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, milling machine and associated tooling and accessories.

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

The subject devices have similar Indications for Use, intended use, designs, sizes and configurations, materials, and principles of operation as the primary predicate device Elos Accurate® Customized Abutment Device (K190299, K171799, K192457, K191890). In order to determine nominal dimensions and tolerances of the Elos Accurate® Customized Abutment 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 identical except for the change in manufacturing from an FDA registered Elos Medtech approved milling facility to that the abutments should be designed and manufactured using a specific digital dentistry workflow.

The clamping of the Subject device during milling is changed to the opposite end than the connection interface which differ from Primary Predicate Device (K190299, K171799, K 192457, K 191890). This difference has no impact on the final customized abutunent design.

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| Element of Comparison | Indications for Use | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|-----------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|
| Subject Device | The Elos Accurate® Customized Abutments are intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Elos Accurate® Customized Abutment will be attached to a dental implant using the included Elos Prosthetic screw. The Elos Accurate® Customized Abutments are compatible with the implant systems listed in table 1:<br>Table 1. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Elos Accurate®<br>Customized<br>Abutment | Platform compatibility Platform diameter [mm] Implant Body diameter [mm] Nobel Replace NP 3.5 3.5 Nobel Replace RP 4.3 4.3 Nobel Replace WP 5 5 Nobel Replace 6.0 6 6 Nobel CC 3.0 3 3 Nobel CC NP 3.5 3.5 & 3.75 Nobel CC RP 3.9 4.3 & 5 Nobel CC WP 5.1 5.5 Straumann Bone Level NC 3.3 3.3 Straumann Bone Level RC 4.1&4.8 4.1 & 4.8 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 EV 3.6 3.6 3.6 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 5.4 5.4 5.4 Brånemark NP 3.5 3.3 Brånemark RP 4.1 3.75.4 & 5 Brånemark WP 5.1 5 & 6 All digitally designed CAD/CAM customizations for the Elos Accurate® Customized Abutments are only intended 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, milling machine and associated tooling and accessories. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Primary Predicate<br>Devices (K190299<br>171799, 192457,<br>191890)<br>Elos Accurate®<br>Customized<br>Abutment | The Elos Accurate® Customized Abutments are intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Elos Accurate® Customized Abutment will be attached to a dental implant using the included Elos Prosthetic screw. The Elos Accurate® Customized Abutments are compatible with the implant systems listed in table 1:<br>Table 1. Platform compatibility Platform diameter [mm] Implant Body diameter [mm] Nobel Replace NP 3.5 3.5 Nobel Replace RP 4.3 4.3 Nobel Replace WP 5 5 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

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| Nobel CC 3.0 | 3 | 3 |
|-------------------------|---------|-------------|
| Nobel CC NP | 3.5 | 3.5 & 3.75 |
| Nobel CC RP | 3.9 | 4.3 & 5 |
| Nobel CC WP | 5.1 | 5.5 |
| Straumann Bone Level NC | 3.3 | 3.3 |
| Straumann Bone Level RC | 4.1&4.8 | 4.1 & 4.8 |
| 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 EV 3.6 | 3.6 | 3.6 |
| 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 5.4 | 5.4 | 5.4 |
| Brånemark NP | 3.5 | 3.3 |
| Brånemark RP | 4.1 | 3.75, 4 & 5 |
| Brånemark WP | 5.1 | 5 & 6 |

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| Element of Comparison | Subject Device | Primary Predicate Device | Reference device |
|-----------------------------------------------|------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| | Elos Accurate® Customized<br>Abutment<br>Elos Medtech Pinol A/S | K190299, K192457, K171799, K191890<br>Elos Accurate® Customized<br>Abutment<br>Elos Medtech Pinol A/S | K201860<br>Elos Accurate® Hybrid Base<br>Elos Medtech Pinol A/S |
| Intended Use | Support of a prosthesis to restore<br>chewing function | Support of a prosthesis to restore<br>chewing function | Support of a prosthesis to restore<br>chewing function |
| Reason for<br>Predicate/Reference | Not applicable | Abutment Design<br>Engineering and dimensional<br>analysis | Digital dentistry workflow |
| Abutment Designs | Customized abutment<br>mounted on the implant fixed<br>with a screw | Customized abutment mounted<br>on the implant fixed with a<br>screw | 2 piece – zirconia bonded to<br>hybrid base mounted on to the<br>implant and fixed with a screw |
| Prosthesis<br>Attachment | Abutment screw-retained to<br>implant | Abutment screw-retained to<br>implant | Abutment screw-retained to<br>implant<br>Superstructure cement-<br>retained |
| Restoration | Single-unit<br>Multi-unit | Single-unit<br>Multi-unit | Single-unit<br>Multi-unit |
| Abutment/Implant<br>Platform Diameter<br>(mm) | 3.0 - 6.0 | 3.0 - 6.0 | 3.0 - 6.0 |
| Abutment Angle | Up to 30° maximum | Up to 30° maximum | 20° maximum |
| Materials | | | |
| Abutment | Ti-6Al-4V alloy | Ti-6Al-4V alloy | Ti-6Al-4V alloy |
| Screw | Ti-6Al-4V alloy | Ti-6Al-4V alloy | Ti-6Al-4V alloy |
| Surface | Non-coated,<br>Medicarb coating on screw | Non-coated,<br>Medicarb coating on screw | Non-coated,<br>Medicarb coating on screw |
| Design Workflow | 3Shape scanner (3Shape A/S),<br>3Shape Abutment Designer<br>Software (3Shape A/S) -<br>K151455 | Elos Medtech approved milling<br>facility. | 3Shape scanner (3Shape A/S),<br>3Shape Abutment Designer<br>Software (3Shape A/S) -<br>K151455 |
| Manufacturing<br>Workflow | CORITEC milling unit (imes-<br>icore) | Elos Medtech approved milling<br>facility. | CORITEC milling unit (imes-<br>icore) |

The data included in this submission demonstrate substantial equivalence to the predicate device and/or reference device listed above.

Overall, the subject device has the following substantial equivalencies to the predicate device:

- has the same intended use,
- uses the same operating principle, ●
- incorporates the same basic design, ●
- incorporates the same or very similar materials, and
- is to be sterilized using the same processes.

#### X. Discussion of the Non-Clinical Testing:

Non clinical testing data submitted (either in subject- or predicate submission) included:

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- . Engineering and dimensional analysis of original manufactures' components (abutments, implants & abutinent screws) for determination of compatibility. (The compatibility analysis is conducted on primary predicate device (K190299, K171799, K192457, K191890) and can be leveraged to the subject Elos Accurate Customized Abutments as material, size and geometry are substantial equivalent)
- . Fatigue testing per ISO 14801 according to FDA guidance for Industry and FDA Staff "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" dated May 12, 2004. The Fatigue test are conducted on the primary predicate device (K190299, K171799, K192457, K191890) and can be leveraged to the subject Elos Accurate Customized Abutments as material, size and geometry are substantial equivalent
- Biocompatibility testing for cytotoxicity according to ISO 10993-5. Tests included ● covered:
- non-coated prosthetic screw representative for subject device (test of primary .
- . predicate device K190299)
- Medicarb coated prosthetic screw representative for subject device (test of -
- primary predicate device K171799) -
- Elos Accurate® Customized Abutment representative for subject devices (test of . primary predicate device (K171799))
- . Sterilization validation according to ISO 17665-1 & ISO 17665-2, demonstrating a SAL of 10°. (The sterilization and Dry-time studies are conducted on the Primary Predicate Device (K171799) and can be leveraged to the subject Elos Accurate Customized Abutnents as material, size and geometry are substantial equivalent)
- . The digital dentistry workflow validation was completed on selected model of subject product line with a digital dentistry workflow including a 3Shape scanner, 3Shape Abutment Designer Software (K155415) and CORiTEC Imes-Icore milling unit. The validation was provided for the subject abutment design library (not allowing the user to design outside the design limits set by Elos Medtech) to demonstrate use with the 3Shape Abutment Designer™ Software (K151455). The design library file (DME-file) provided by Elos Medtech includes design limits in accordance with Electronic Package insert -Instruction For Use, Surgical & Prosthetic Guide - In Lab Milling. The 3Shape Abutment Designer™ Software (K151455) prevents designing outside the specified design limits in the library file.
- . Elos Medtech Pinol A/S solely manufactures abutments and screws in TiAl6V4 ELI. The screws are either uncoated or Medicarb coated. The Customized Abutments are delivered uncoated for machining by the dental lab. The screws and abutments are designed to be compatible with many different implant systems from implant manufacturers, which are made of titanium allovs, mostly titanium grade 4 (commercially pure Ti). TiAl6V4 ELI. commercially pure Ti and the used coating does not contain ferromagnetic materials (such as Fe, Co and Ni), meaning that the MRI response will be limited. To verify that a worstcase assembly made of Elos Medtech devices was MR conditional, a range of tests was performed on the worst-case assembly according to ASTM F2052, ASTM F2119, ASTM F2213 and ASTM F2182. The device has been assessed at 1.5 Tesla and 3 Tesla for displacement, torque, heating and image artifact in the MRI scanner, which proved that the proposed devices are MR conditional to use when having an MRI scan.
- . To address the potential risk of damage to the implant-abutiment connection geometry during the milling of the patient-matched portions of the abutment blanks, validation

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testing of CAM restriction zones was conducted, including verification to show avoidance of damage or modification of the connection geometry, and locking of restriction zones from user editing in the CAM software.

#### XI. Conclusions:

Based on the test results and additional supporting documentation provided in this premarket notification, the subject devices demonstrated substantial equivalence to the previously listed predicate devices.