Elos Accurate Hybrid Base

K191919 · Elos Medtech Pinol A/S · NHA · Feb 10, 2020 · Dental

Device Facts

• Record ID: K191919
• Device Name: Elos Accurate Hybrid Base
• Applicant: Elos Medtech Pinol A/S
• Product Code: NHA · Dental
• Decision Date: Feb 10, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2

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 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.

Device Story

Elos Accurate® Hybrid Base is a titanium base interfacing between dental implants and zirconia superstructures; supports single-unit (engaging) or multi-unit (non-engaging) restorations. Device consists of titanium base and prosthetic screw; zirconia superstructure is cemented to base. Used in dental clinics; operated by dentists/prosthodontists. Digitally designed superstructures must be manufactured at FDA-registered Elos Medtech-approved milling facilities. Provides stable interface for definitive prosthetic restorations; benefits patient by restoring chewing function.

Clinical Evidence

No clinical data included. Substantial equivalence supported by bench testing: biocompatibility (ISO 10993-5 cytotoxicity) and dynamic compression-bending fatigue testing (ISO 14801). Engineering/dimensional analysis confirmed compatibility with OEM implant bodies, abutments, and screws.

Technological Characteristics

Materials: Ti-6Al-4V alloy (ASTM/ISO compliant), Zirconia (ISO 13356). Interface: Internal connection. Form factor: Two-piece abutment (titanium base + zirconia superstructure). Surface: Anodized or non-anodized; Medicarb (DLC) coating on screws. Sterilization: Validated per ISO 17665-1/2. Connectivity: N/A (mechanical device).

Indications for Use

Indicated for patients requiring single or multiple tooth prosthetic restorations supported by dental implants. Compatible with specific Nobel Biocare, Straumann, and Astra Tech implant systems. Contraindications include patients where the device cannot be properly attached to the implant or superstructure.

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

• DESS Dental Smart Solutions (K173908)

Reference Devices

• BioHorizons CAD/CAM Abutments (K151621)
• Elos Accurate® Customized Abutment (K171799)
• Preat Abutments (K183518)
• OsseoSpeed Narrow (K080396)
• Fixture MicroThread OsseoSpeed (K053384)
• OsseoSpeed Plus (K120414)
• NobelActive 3.0 (K102436)
• NobelActive Internal Connection Implant (K071370)
• NobelActive Wide Platform (WP) (K133731)
• Replace TiUnite Endoessous Implant (K023113)
• P.0004 Implants (Straumann Dental Implant System) (K062129)
• Multilink Hybrid Abutment Cement (K130436)

Submission Summary (Full Text)

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February 10, 2020

Elos Medtech Pinol A/S % Floyd Larson President PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130

Re: K191919

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 Dated: January 6, 2020 Received: January 7, 2020

Dear Floyd Larson:

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 (OS) 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.

for

Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental 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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## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

Device Name

Elos Accurate® Hybrid Base

K191919

#### Indications for Use (Describe)

The Elos Accurate® Hybrid Base™ is intended for attaching to dental implants in order to single or multiple tooth prostheto restorations. The Hybrid Base" is used as an interface between a dental implant and a zirconia superstructure and will be attached to the included 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 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 3.0 | 3 | 3 |
| 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 3.0 | 3 | 3 |
| 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 |

All digitally designed zirconia superstructures for use "Hybrid Base" are only intended to be sent and manufactured at an FDA registered Elos Medtech approved milling facility.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(k) Summary

# K191919

# Elos Medtech Pinol A/S Elos Accurate® Hybrid Base™

February 10, 2020

## ADMINISTRATIVE INFORMATION

| Manufacturer Name | Elos Medtech Pinol A/S<br>Engvej 33<br>DK-3330 Gørløse, Denmark<br>Telephone [phone] | | | |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|
| Official Contact | Tina Friis Poulsen, Head of Compliance | | | |
| Representative/Consultant | Floyd G. Larson, MS, MBA<br>Kevin A. Thomas, PhD<br>PaxMed International, LLC<br>12264 El Camino Real, Suite 400<br>San Diego, CA 92130<br>Telephone: [phone]<br>Fax: [phone]<br>Email: [e-mail]<br>[e-mail] | | | |

## DEVICE NAME AND CLASSIFICATION

| Trade/Proprietary Name | Elos Accurate® Hybrid Base™ |
|------------------------|------------------------------------|
| Common Name | Dental implant abutment |
| Regulation Number | 21 CFR 872.3630 |
| Regulation Name | Endosseous dental implant abutment |
| Regulatory Class | Class II |
| Product Code | NHA |
| Classification Panel | Dental Products Panel |
| Reviewing Division | DHT1B: Division of Dental Devices |

## PREDICATE DEVICE INFORMATION

Primary Predicate K173908, DESS Dental Smart Solutions, Terrats Medical SL

Reference Devices K151621, BioHorizons CAD/CAM Abutments, BioHorizons Implant Systems, Inc. K171799, Elos Accurate® Customized Abutment, Elos Medtech Pinol A/S K183518, Preat Abutments, Preat Corporation K080396, OsseoSpeed Narrow, Dentsply Sirona K053384, Fixture MicroThread OsseoSpeed, Dentsply Sirona K120414, OsseoSpeed Plus, Dentsply Sirona K102436, NobelActive 3.0, Nobel Biocare AB

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K071370. NobelActive Internal Connection Implant. Nobel Biocare AB K133731, NobelActive Wide Platform (WP), Nobel Biocare AB K023113, Replace TiUnite Endoessous Implant, Nobel Biocare AB K062129, P.0004 Implants (Straumann Dental Implant System), Institut Straumann K130436, Multilink Hybrid Abutment Cement, Ivoclar Vivadent AG

# 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 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.

| Table 1. | | |
|--------------------------------|------------------------------|----------------------------------|
| Implant Platform compatibility | Platform<br>diameter<br>[mm] | Implant Body<br>diameter<br>[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 3.0 | 3 | 3 |
| 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 3.0 | 3 | 3 |
| 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 |

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

All digitally designed zirconia superstructures for use with the Elos Accurate® Hybrid Base™ are only intended to be sent and manufactured at an FDA registered Elos Medtech approved milling facility.

# DEVICE DESCRIPTION

The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant and to support a patient-specific ceramic superstructure or a multi-unit direct restoration cemented to the base. The base and the superstructure form a patient-specific abutment that will support a definitive restoration, either a single crown or a multi-unit restoration. The Elos Accurate Hybrid Base Engaging is intended for single-unit restorations and Elos Accurate Hybrid Base Nonengaging is intended for multi-unit restorations. Alternatively, a definitive multi-unit restoration may be cemented directly to the Elos Accurate Hybrid Base.

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Manufacture of the final finished device will be at an Elos Medtech-approved milling facility that is registered with FDA as a medical device manufacturer and is qualified as a contract manufacturer to Elos Medtech.

This submission includes a two-piece abutment (titanium base and zirconia superstructure) and abutment screws compatible with OEM implants from Dentsply Implants (Astra Tech TX, Astra Tech EV), Nobel Biocare (Nobel Active/Conical Connection and Nobel Replace) and Institut Straumann (Straumann Bone Level NC and RC).

Abutments compatible with Astra Tech implants are available in engaging (anti-rotational) designs, and all others are available in both engaging and non-engaging designs.

## PERFORMANCE DATA

Non-clinical data submitted to demonstrate substantial equivalence include: biocompatibility evaluation and confirmatory cytotoxicity testing according to ISO 10993-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity, and dynamic compression-bending testing according to ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants. No clinical data were included in this submission.

Substantial equivalence with regard to compatibility with OEM components is supported by engineering and dimensional analysis of OEM implant bodies, OEM abutments and OEM abutment fixation screws to confirm compatibility.

Substantial equivalence with regard to mechanical performance is supported by dynamic testing according to ISO 14801 Dentistry – Implants – Dynamic fatigue test for endosseous dental implants.

The coatings used on selected screws are identical to coatings on previously cleared devices. The Medicarb coating is identical to the Medicarb (DLC) coating on reference device K171799 and the Nobel DLC coating is identical to the DLC coating on compatible device K071370. Sterilization validation of the reprocessing instructions were conducted in accordance to ISO 17665-1 and ISO 17665-2.

Minor differences in the designs, dimensions, sizes, or compatible OEM implant lines among the subject device, the primary predicate device, and the reference devices do not affect substantial equivalence. These minor differences do not impact a determination of substantial equivalence because these differences are related to the compatible OEM implant designs or are mitigated by the mechanical performance testing.

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# EQUIVALENCE TO MARKETED DEVICE

Overall, the subject device has the following similarities to the predicate devices:

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

The basis for the belief of Elos Medtech Pinol A/S that the subject device is substantially equivalent to the predicate devices is summarized in the following Table of Substantial Equivalence.

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| Subject Device | Primary Predicate | Reference Device | Reference Device | Reference Device | | | | | | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|---------------------|-------------------------------------------|-------------------------------|-----------------------------------------|
| | K173908 | K151621 | K171799 | K183518 | | | | | | | |
| Elos Accurate® Hybrid BaseTM | DESS Dental Smart Solutions | BioHorizons CAD/CAM Abutments | Elos Accurate® Customized Abutment, | Preat Abutments | | | | | | | |
| | | BioHorizons Implant Systems, Inc. | Elos Medtech Pinol A/S | Preat Corporation | | | | | | | |
| Elos Medtech Pinol A/S | Terrats Medical SL | | | | | | | | | | |
| The Elos Accurate® Hybrid BaseTM is intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Hybrid BaseTM 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. | DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.<br>All digitally designed custom abutments for use with AurumTM Abutment or Pre-milled Blank are to be sent to a Terrats Medical validated milling center for manufacture. | BioHorizons CAD/CAM Abutments are dental abutments placed onto a dental implant to provide support for dental prosthetic restorations. The abutments include: 1) Titanium abutment blanks with a pre-machined implant connection where the upper portion may be custom-milled in accordance with a patient-specific design using CAD/CAM techniques; and 2) Titanium bases with a pre-machined implant connection upon which a CAD/CAM designed superstructure may be fitted to complete a two-piece dental abutment. The abutments include an abutment screw for fixation to the underlying implant. The abutments may be used for single-unit (single-tooth) or multiple-unit (bridges and bars) restorations and are compatible for use with BioHorizons Internal and Tapered Internal implant systems and Zimmer® Dental Screw-Vent® and Tapered Screw-Vent® implants with 3.5mm, 4.5mm and 5.7mm internal hex-connection mating platform diameters.<br>All digitally designed abutments and/or copings for use with BioHorizons CAD/CAM Abutments are intended to be sent to a BioHorizons-validated milling center for manufacture. BioHorizons abutments designed using CAD/CAM techniques must fulfill the BioHorizons allowable range of design parameters. | 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.<br>The Elos Accurate® Customized Abutments are compatible with the following implant systems: | Preat Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit on multi-unit prosthetic restorations. The Titanium Base abutments consists of two major parts. Specifically, the titanium base and mesostructured components make up a two-piece abutment.<br>All digitally designed custom abutments, superstructures, and/or hybrid crowns for use with Titanium Base or Titanium Blank are to be sent to a Preat validated milling center for manufacture. | | | | | | | |
| The Elos Accurate® Hybrid BaseTM is compatible with the implant systems listed in Table 1. | Compatible Implant Systems | | | Compatible Implant Systems | | | | | | | |
| Table 1. | | | | | | | | | | | |
| Implant Platform<br>compatibility | Platform<br>diameter<br>[mm] | Implant<br>Body<br>diameter<br>[mm] | Implant System<br>Compatibility | Implant Body | Implant<br>Platform | Ref. No. | Platform<br>compatibility | Implant<br>diameter | Compatible Implant System | Implant Body<br>Diameter (mm) | Implant<br>Platform<br>Diameter<br>(mm) |
| Nobel Replace NP | 3.5 | 3.5 | 3i Certain® | 3.25, 4.0, 5.0 | 3.4, 4.1, 5.0 | AB-BRA411213-US | Nobel Biocare®/<br>Brånemark® RP | 3.75 mm<br>& 4 mm | 3i OSSEOTITE® Certain® | 3.25 | 3.4 |
| Nobel Replace RP | 4.3 | 4.3 | 3i OSSEOTITE® | 3.25, 3.75,<br>4.0, 5.0 | 3.4, 4.1, 5.0 | AB-BRA351213-US | Nobel Biocare®/<br>Brånemark® RP | 3.3 mm | | 4.0 | 4.1 |
| Nobel Replace WP | 5 | 5 | OsseoSpeedTM | 3.5, 4.0, 5.0 | 3.5/4.0, 4.5/5.0 | AB-BRA511213-US | Nobel Biocare®/<br>Brånemark® RP | 5 mm | | 5.0 | 5.0 |
| Nobel Replace 6.0 | 6 | 6 | FRIADENT XIVE | 3.4, 3.8, 4.5 | 3.4, 3.8, 4.5 | All digitally designed Elos Accurate® Customized<br>Abutments are intended to be manufactured at an Elos<br>Medtech approved milling facility. | | | | 6.0 | 6.0 |
| Nobel CC 3.0 | 3 | 3 | NobelActive® | 3.5, 4.3, 5.0 | NP, RP | | | | Astra Tech OsseoSpeedTM | 3.0 | 3.0 |
| Nobel CC NP | 3.5 | 3.5 & 3.75 | NobelReplace<br>Conical | 3.5, 4.3, 5.0 | NP, RP | | | | | 3.5, 4.0 | 3.5/4.0 |
| Nobel CC RP | 3.9 | 4.3 & 5 | Nobel Replace<br>Trilobe | 3.5, 4.3, 5.0 | NP, RP, WP | | | | | 4.5, 5.0 | 4.5/5.0 |
| Nobel CC WP | 5.1 | 5.5 | Brånemark | 3.5, 3.75/4.0,<br>5.0 | NP, RP, WP | | | | BioHorizons Tapered Internal | 3.0 | 3.0 |
| Straumann Bone Level NC | 3.3 | 3.3 | Straumann® Bone<br>Level | 3.3, 4.1, 4.8 | NC, RC | | | | | 3.5 | 3.5 |
| Straumann Bone Level RC…