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[mm]	Implant Body diameter[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

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 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
1. Minimum post height 4.0 mm (for single unit restorations)
1. Maximum gingival height 5.0 mm (min. GH of 0.5mm)
1. 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.

AI/ML Overview

The Elos Accurate® Hybrid Base™ is a dental device intended for attaching to dental implants to provide a basis for single or multiple tooth prosthetic restorations. It acts as an interface between a dental implant and a zirconia superstructure.

Here's a breakdown of the acceptance criteria and supporting studies:

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Demonstrates Substantial Equivalence)	Reported Device Performance
Intended Use (Support of a prosthesis to restore chewing function)	Substantially equivalent to predicate.
Abutment Designs (2-piece - zirconia bonded to hybrid base mounted on implant and fixed with a screw)	Substantially equivalent to predicate.
Prosthesis Attachment (Abutment screw-retained to implant, superstructure cement-retained)	Substantially equivalent to predicate.
Restoration (Single-unit, Multi-unit)	Substantially equivalent to predicate.
Abutment/Implant Platform Diameter (mm) (Up to 7.0mm, larger than predicate (3.0-6.0mm) but not a new worst-case)	Subject device supports 3.2 - 7.0mm implant diameters. The larger diameter does not represent a new worst-case scenario and thereby affects the safety of the product.
Abutment Angle (20° maximum)	Substantially equivalent to predicate (20° maximum).
Materials - Abutment (Ti-6Al-4V alloy)	Substantially equivalent to predicate.
Materials - Screw (Ti-6Al-4V alloy)	Substantially equivalent to predicate.
Materials - Zirconia superstructure (3M Lava zirconia)	Substantially equivalent to predicate.
Surface - Abutment (Anodized)	Subject abutment is anodized, identical to predicate.
Surface - Screw (Non-coated, Medicarb coated)	Medicarb coating identical to predicate. Mechanical performance demonstrated in fatigue testing.
Design Workflow (3Shape intra oral scanner, 3Shape Abutment Designer Software, K151455)	Substantially equivalent; specific new digital libraries validated as part of the submission.
Manufacturing Workflow (CORITEC milling unit)	Substantially equivalent.
Fatigue Testing (Per ISO 14801, FDA guidance)	Performed on subject devices, demonstrating equivalence with predicate devices.
Engineering and Dimensional Analysis (For compatibility with original manufacturers' components)	Performed on subject devices, confirming compatibility.
Sterilization Validation (Per ISO 17665-1 & ISO 17665-2, SAL of 10^-6)	Demonstrated for the device.
Biocompatibility (Per ISO 10993-1, ISO 10993-5 - Cytotoxicity)	Cytotoxicity test performed on a complete restoration, showing non-cytotoxic. Leveraged from previously cleared products.
MR Conditional Labeling	Leveraged from predicate devices (K222044).

Sample Size Used for the Test Set and the Data Provenance:
- Fatigue Testing: "fatigue testing was performed on the subject devices per ISO 14801." The exact number of samples tested per device type is not specified but implied to be sufficient for ISO 14801 compliance.
- Engineering and Dimensional Analysis: Performed on "original manufactures' components (abutments, implants & abutment screws)." The number of components is not specified.
- Digital Dentistry Workflow Validation/Design Limitation Test: "The digital dentistry workflow validation was completed on selected models of subject product line" and "A design limitation test is performed...". Number of models/tests not specified.
- Biocompatibility (Cytotoxicity): A cytotoxicity test was performed on "a complete restoration produced via the described validated workflow." Exact number of samples not specified.
- Data Provenance: Not explicitly stated, but the testing appears to be conducted by or for the manufacturer (Elos Medtech Pinol A/S). No information is given about the country of origin of the data or if it was retrospective or prospective in the context of clinical studies (as this is a non-clinical submission).
Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- This submission focuses on non-clinical testing and substantial equivalence to predicate devices based on engineering and performance standards. There is no mention of "experts" establishing ground truth in the context of diagnostic performance or clinical outcomes. The "ground truth" for the engineering and material properties would be established by validated test methods and established standards (e.g., ISO 14801, ISO 10993).
Adjudication Method for the Test Set:
- Not applicable. This is a non-clinical submission based on engineering tests and standards, not a clinical study requiring adjudication of diagnostic results.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC study was mentioned or performed. This device is a dental implant component, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" in this context refers to established engineering standards, material properties, and performance requirements for dental implant abutments. This includes:
  - ISO 14801: "Dentistry – Implants – Dynamic fatigue test for endosseous dental implants" for fatigue testing.
  - ISO 17665-1 & ISO 17665-2: For sterilization validation.
  - ISO 10993-1 & ISO 10993-5: For biocompatibility (cytotoxicity).
  - Engineering and dimensional analysis: Based on specifications of original manufacturers' components.
The sample size for the training set:
- Not applicable. This device is not an AI/machine learning product and does not have a "training set." The closest analogy could be the design and manufacturing parameters used to create the device, which are based on established engineering principles and prior device knowledge.
How the ground truth for the training set was established:
- Not applicable, as there is no "training set" for this type of medical device. The design and manufacturing are based on established engineering principles and validation against performance standards.

Summary

{0}------------------------------------------------

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.

{1}------------------------------------------------

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

{2}------------------------------------------------

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 compatible with the implant systems listed in table 1:

Implant Platform compatibility	Platform diameter[mm]	Implant Body diameter[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.

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)

{3}------------------------------------------------

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/SEngvej 33DK-3330 GoerloeseDenmark
Contacts:	Lise TerkelsenRegulatory Affairs Professional
	Tel: +45 21 61 12 25
	E-mail: lise.terkelsen@elosmedtech.com
	Søren Rangstrup
	Manager of Product Development & Regulatory Affair
	Tel: +45 20 66 64 42
	E-mail: soren.rangstrup@elosmedtech.com
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 ●

{4}------------------------------------------------

. 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.

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

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.

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:

{5}------------------------------------------------

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 Platformcompatibility	Platform diameter[mm]	Implant Body diameter[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 StandardWN	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

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

{6}------------------------------------------------

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)

{7}------------------------------------------------

Indications for UseSubject Device		Indications for UsePrimary Predicate Device (201860)		Indications for UseReference Device (K191919)		Discussion
Elos Accurate® Hybrid Base™		Elos Accurate® Hybrid Base™		Elos Accurate® Hybrid Base™
The Elos Accurate® Hybrid Base™ is intended forattaching to dental implants in order to provide basis forsingle or multiple tooth prosthetic restorations. TheHybrid Base™ is used as an interface between a dentalimplant and a zirconia superstructure and will beattached to the implant using a prosthetic screw andattached to the zirconia superstructure by cementing.The Elos Accurate® Hybrid Base™ is compatible withthe implant systems listed in table 1:		The Elos Accurate® Hybrid Base™ is intended forattaching to dental implants in order to provide basis forsingle or multiple tooth prosthetic restorations. TheHybrid Base™ is used as an interface between a dentalimplant and a zirconia superstructure and will beattached to the implant using a prosthetic screw andattached to the zirconia superstructure by cementing.The Elos Accurate® Hybrid Base™ is compatible withthe implant systems listed in table 1:		The Elos Accurate® Hybrid Base™ is intended forattaching to dental implants in order to provide basis forsingle or multiple tooth prosthetic restorations. TheHybrid Base™ is used as an interface between a dentalimplant and a zirconia superstructure and will beattached to the implant using a prosthetic screw andattached to the zirconia superstructure by cementing.The Elos Accurate® Hybrid Base™ is compatible withthe implant systems listed in table 1:		The Indication for use for the subject device issimilar to the Primary Predicate Device (K201860)and Reference Device (K191919), beside table 1.which have been extended with 5 new implantsystems, and the approach for finalizing thezirconia superstructure have been merged for thePrimary Predicate Device (K201860) andReference Device (K191919) so the zirconiasuperstructure either can be manufactured at aFDA registered Elos Medtech approved millingfacility or to be designed and manufacturedaccording to digital dentistry workflow.The difference in implant system compatibility issubstantiated by engineering and dimensionalanalysis of original manufactures' components(abutments, implants & screws) for determinationof compatibility and new fatigue testing.
Table 1.		Table 1.		Table 1.
ImplantPlatformcompatibility	Platformdiameter[mm]	ImplantBodydiameter[mm]	Implant Platformcompatibility	Platformdiameter[mm]	ImplantBodydiameter[mm]	Implant Platformcompatibility	Platformdiameter[mm]	ImplantBodydiameter[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	03.5/04.5/05.5/06.5	03.5/03.75/04/04.3/05/0 6/0 7	Straumann Bone	4.1 & 4.8	4.1 & 4.8	Straumann Bone	4.1 & 4.8	4.1 & 4.8
Hiossen ETMini	03.2/03.5	03.2/03.5	Astra Tech 3.0	3	3	Astra Tech 3.0	3	3
Hiossen ETRegular	04/04.5/05/05.5/06/07	04/04.5/05/05.5/06/07	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	3.5	3.3
			Brånemark RP	4.1	3.75, 4 & 5	Brånemark RP	4.1	3.75, 4 & 5
			Brånemark WP	5.1	5 & 6	Brånemark WP	5.1	5 & 6
The zirconia superstructures for use with the ElosAccurate® Hybrid Base™ are either intended to be sentand manufactured at a FDA registered Elos Medtechapproved milling facility or to be designed andmanufactured according to digital dentistry workflow.The workflow system integrates multiple components ofthe digital dentistry workflow: scan files from Intra-OralScanners, CAD software, CAM software, ceramicmaterial, milling machine and associated tooling andaccessories.		The zirconia superstructures for use with the ElosAccurate® Hybrid Base™ are only intended to bedesigned and manufactured according to digitaldentistry workflow. The workflow system integratesmultiple components of the digital dentistry workflow:scan files from Intra-Oral Scanners, CAD software,CAM software, ceramic material, milling machine andassociated tooling and accessories.		All digitally designed zirconia superstructures for usewith the Elos Accurate® Hybrid Base™ are onlyintended to be sent and manufactured at a FDAregistered Elos Medtech approved milling facility.

Uncontrolled Copy

{8}------------------------------------------------

Element ofComparison	Subject Device	Primary PredicateDevice K201860	ReferenceK191919	Discussion
	Elos Accurate®Hybrid Base™Elos Medtech PinolA/S	Elos Accurate®Hybrid Base™Elos Medtech PinolA/S	Elos Accurate®Hybrid Base™Elos Medtech PinolA/S
Intended Use	Support of a prosthesisto restorechewing function	Support of aprosthesis to restorechewing function	Support of aprosthesis to restorechewing function	Substantialequivalent
Reason forPredicate/Reference	Not applicable	Indication for Use,Abutment Designand manufacturingworkflow	Indication for Use,Abutment Designand manufacturingworkflow	N/A
Abutment Designs	2 piece - zirconiabonded to hybrid basemounted on to theimplant and fixed witha screw	2 piece - zirconiabonded to hybridbase mounted on tothe implant andfixed with a screw	2 piece - zirconiabonded to hybridbase mounted on tothe implant andfixed with a screw	Substantialequivalent
ProsthesisAttachment	Abutment screw-retained to implantSuperstructure cement-retained	Abutment screw-retained to implantSuperstructurecement-retained	Abutment screw-retained to implantSuperstructurecement-retained	Substantialequivalent
Restoration	Single-unitMulti-unit	Single-unitMulti-unit	Single-unitMulti-unit	Substantialequivalent
Abutment/ImplantPlatform Diameter(mm)	3.2 - 7.0	3.0-6.0	3.0 - 6.0	Implant diameterfor the subjectdevice is up to7.0mm, which islarger than theprimary predicatedevice. The largerdiameter does notrepresent a newworst case scenarioand thereby affectthe safety of theproduct.
Abutment Angle	20° maximum	20° maximum	20°maximum	Substantialequivalent
Materials
-Abutment	Ti-6Al-4V alloy	Ti-6Al-4V alloy	Ti-6Al-4V alloy	Substantialequivalent
- Screw	Ti-6Al-4V alloy	Ti-6Al-4V alloy	Ti-6Al-4V alloy	Substantialequivalent
-Zirconiasuperstructure	3M Lava zirconia	3M Lava zirconia	3M Lava zirconia	Substantialequivalent
Surface	Abutment: AnodizedScrew: Non-coated,Medicarb coated	Abutment: AnodizedScrew: Non-coated,Medicarb coated	Abutment: Anodized,non-anodizedScrew: Non-coatedMedicarb coated	The SubjectAbutment isanodized as thepredicate abutment.The MediCarbcoating is identical
				to the predicatedevices.Mechanicalperfomance isdemonstrated infatigue testing.
Design Workflow	3Shape intra oralscanner Trios (3ShapeA/S), 3ShapeAbutment DesignerSoftware (3Shape A/S)- K151455	3Shape intra oralscanner Trios(3Shape A/S),3Shape AbutmentDesigner Software(3Shape A/S) -K151455	Elos Medtechapproved millingfacility.	Substantialequivalent
ManufacturingWorkflow	CORITEC milling unit(Imes-Icore)	CORITEC millingunit (imes-icore)	Elos Medtechapproved millingfacility.	Substantialequivalent

{9}------------------------------------------------

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:

fatigue testing was performed on the subject devices 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.
. engineering and dimensional analysis of original manufactures' components (abutments, implants & abutment screws) was performed on the subject devices for determination of compatibility.
. Sterilization validation according to ISO 17665-1 & ISO 17665-2, demonstrating a SAL of 10 .
. The digital dentistry workflow validation was completed on selected models 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 predicate K201860 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 included 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. Since the subject device use identical design and manufacturing workflow (as for the Primary Predicate Device K201860), including identical design limits build in the design library file (DME-file), the subject device does not represent any new worst case, than the worst case documented in

{10}------------------------------------------------

K201860. Hence the new variants are thereby covered by existing workflow validation submitted in K201860. A design limitation test is performed with the purpose of demonstrating in 3Shape Dental System design software, that the user cannot design the zirconia superstructure for Elos Accurate Hybrid base outside the limitations built in the digital libraries relevant for this submission, provided by Elos Medtech.

Biocompatibility was evaluated according to ISO 10993-1 and the FDA guidance document . Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" issued June 16. 2016. Based on this guidance and the common usage of the employed materials demonstrating biocompatibility via cytotoxicity testing was found sufficient. A cytotoxicity test according to ISO 10993-5 of a complete restoration produced via the described validated workflow was performed. Cytotoxicity testing on identically manufactured hybrid bases and prosthetic screws along with zirconia superstructures manufactured from the same material is also leveraged from previously 510(k) cleared products (K171799 and K191919). All tests showed the products to be non-cytotoxic.
. MR Conditional labeling testing is being leveraged from predicate devices in K222044 and the subject devices do not present a new worst-case for the leveraged testing.

XI. Conclusions:

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

Regulation Number and Section

§ 872.3630 Endosseous dental implant abutment.

(a)
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.(b)
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.)