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.

Elos Accurate CustomizedAbutment - Model Type	Platform compatibility	Platform diameter[mm]	Implant Body diameter[mm]
AB-NBR35	Nobel Replace NP	3.5	3.5
AB-NBA30	Nobel CC 3.0	3	3
AB-NBA43	Nobel CC RP	3.9	4.3 & 5
AB-NBA60	Nobel CC WP	5.1	5.5
AB-SBO33	Straumann Bone Level NC	3.3	3.3
AB-SBO41	Straumann Bone Level RC	4.1 & 4.8	4.1 & 4.8

All digitally designed CAD/CAM customizations for the Elos Accurate® Customized Abutments are only intended to be sent and manufactured at a FDA registered Elos Medtech approved milling facility.

Device 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 Abutment 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 by an Elos Medtech approved milling facility. The Elos Accurate® Customized Abutment is delivered nonsterile 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.

AI/ML Overview

The provided text describes the Elos Accurate® Customized Abutment, a dental device, and its FDA 510(k) clearance. This document is a regulatory submission, not a study report detailing AI/ML model performance. Therefore, many of the requested criteria related to AI/ML model evaluation are not applicable or cannot be extracted directly from this type of regulatory submission.

However, I can provide information based on the device's performance against engineering and material acceptance criteria, as well as the non-clinical testing performed to demonstrate substantial equivalence to its predicate device. This is primarily focused on mechanical and biological compatibility, not AI/driven diagnostic accuracy.

Here's the information derived from the provided text, adapted to the closest relevant categories:

1. A table of acceptance criteria and the reported device performance

For a device like the Elos Accurate® Customized Abutment, acceptance criteria primarily relate to mechanical properties, biocompatibility, and compatibility with implant systems. The "reported device performance" here refers to the aspects that were tested and deemed acceptable through non-clinical testing to establish substantial equivalence.

Acceptance Criteria Category	Specific Criteria/Test	Reported Device Performance (as demonstrated by testing)
Mechanical Performance	Fatigue Strength & Durability (per ISO 14801 guidance)	Demonstrated acceptable fatigue performance, supporting the extended angulation (up to 30°) and reduced minimum wall thickness (0.4mm) compared to the predicate (20° and 0.5mm respectively). The specific numerical fatigue values are not provided, but the conclusion states "fatigue testing" was performed and supported substantial equivalence.
	Implant System Compatibility (for new compatible platforms)	Demonstrated compatibility with new implant systems: Nobel Replace NP, Nobel CC (3.0, RP, WP), and Straumann Bone Level (NC, RC) through engineering and dimensional analysis.
Biocompatibility	Cytotoxicity (per ISO 10993-5)	Tests showed acceptable cytotoxicity for the non-coated prosthetic screw (subject device), the MediCarb coated screw (predicate device), and the Elos Accurate® Customized Abutment (representative of subject device as per predicate testing).
Sterilization Efficacy	Sterility Assurance Level (SAL) of 10^-6 (per ISO 17665-1 & 17665-2 for steam sterilization)	No additional testing was necessary for the subject device as the primary predicate device (K171799) had already demonstrated an SAL of 10^-6 for steam sterilization, and the subject device will use the same sterilization process.
Manufacturing Consistency	Digital CAD/CAM Customization	All digitally designed customizations must be sent to and manufactured at an FDA-registered Elos Medtech approved milling facility. This is a process control, not a performance metric per se, but ensures the final product meets design specifications.
Design Specifications	Minimum Wall Thickness	0.4 mm (demonstrated to be acceptable through fatigue testing, despite being thinner than the predicate).
	Maximum Angulation	Up to 30° (demonstrated to be acceptable through fatigue testing, an increase from the predicate's 20°).

2. Sample size used for the test set and the data provenance

The document does not specify a "test set" in the context of an AI/ML model. The evaluation here is based on non-clinical testing (mechanical, dimensional, and biocompatibility).

Sample Size: The document does not provide specific numerical sample sizes for the engineering tests (e.g., how many abutments were subjected to fatigue testing). This level of detail is typically found in the full test reports, not the 510(k) summary.
Data Provenance: The data comes from non-clinical laboratory testing and engineering analyses performed by or for Elos Medtech Pinol A/S. The country of origin of the data is not explicitly stated, but the company is located in Denmark. The data is prospective in the sense that these tests were conducted specifically for this submission to demonstrate substantial equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable. The device is a physical dental abutment, not an AI/ML diagnostic tool requiring expert interpretation for "ground truth." Ground truth, in this context, would be established by validated measurement techniques, material science principles, and biological testing standards (e.g., ISO standards for mechanical testing and biocompatibility).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. "Adjudication method" refers to the process of resolving disagreements among human readers or experts for establishing ground truth in a diagnostic study. For this device, acceptance is based on meeting predefined engineering and biological performance standards through validated testing.

5. 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

This is not applicable. No MRMC study was performed as this is not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. This is not an AI algorithm. Its design uses CAD/CAM technology, but the clearance is for the physical abutment itself, not a diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For this device, the "ground truth" or basis for acceptance relies on:

Established engineering standards: e.g., ISO 14801 for fatigue testing of dental implants.
Biocompatibility standards: e.g., ISO 10993-5 for cytotoxicity.
Dimensional analysis: Verifying compatibility with specified implant systems.
Material specifications: Conformance to Titanium Alloy 6Al-4V ELI (medical grade 5).

There is no "expert consensus" in the diagnostic sense or pathology/outcomes data used for device clearance as described in the summary.

8. The sample size for the training set

This is not applicable because there is no AI/ML model for which a "training set" would be used.

9. How the ground truth for the training set was established

This is not applicable because there is no AI/ML model for which training set ground truth would be established.

Summary

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Image /page/0/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 and 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.

June 26, 2019

Elos Medtech Pinol A/S Tina Poulsen Head of Compliance Engvei 33 DK-3330 Goerloese DENMARK

Re: K190299

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 Dated: May 28, 2019 Received: May 28, 2019

Dear Tina Poulsen:

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

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

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

542 of the Act); 21 CFR 1000-1050.

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

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

for

Srinivas Nandkumar, Ph.D. Acting Assistant 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

510(k) Number: K190299 Device Name: Elos Accurate® Customized Abutment

Indications for Use

The Elos Accurate® Customized Abutments are intents 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.

Elos Accurate CustomizedAbutment - Model Type	Platform compatibility	Platform diameter[mm]	Implant Body diameter[mm]
AB-NBR35	Nobel Replace NP	3.5	3.5
AB-NBA30	Nobel CC 3.0	3	3
AB-NBA43	Nobel CC RP	3.9	4.3 & 5
AB-NBA60	Nobel CC WP	5.1	5.5
AB-SBO33	Straumann Bone Level NC	3.3	3.3
AB-SBO41	Straumann Bone Level RC	4.1 & 4.8	4.1 & 4.8

All digitally designed CAD/CAM customizations for the Elos Accurate® Customized Abutments are only intended to be sent and manufactured at a FDA registered Elos Medtech approved milling facility.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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510(k) Summary Elos Accurate® Customized Abutment June 20, 2019

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:	Tina Friis PoulsenHead of ComplianceTel: +45 27 77 11 17E-mail:tina.poulsen@elosmedtech.com
		Magnus Lynge BergholtRegulatory Affairs ManagerTel: +45 48 21 64 58E-mail: magnus.jacobsen@elosmedtech.com
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

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:

K171799 / SE 01/15/2018 Elos Accurate® Customized Abutment .

Reference Devices:

K023113 / SE 09/26/2002 NOBEL REPLACE TIUNITE ENDOSSEOUS ● IMPLANT
K083550 / SE 02/26/2009 - STRAUMANN DENTAL IMPLANT SYSTEM
K102436 / SE 12/09/2010 NOBEL ACTIVE 3.0 ●
. K071370 / SE 08/03/2007 – NOBEL ACTIVE INTERNAL CONNECTION IMPLANT
K133731 / SE 05/08/2014 NOBEL ACTIVE WIDE PLATFORM (WP) ●

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VII. Product Description:

VIII. Indications for Use:

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

Elos Accurate CustomizedAbutment - Model Type	Platformcompatibility	Platformdiameter[mm]	Implant Bodydiameter[mm]
AB-NBR35	Nobel Replace NP	3.5	3.5
AB-NBA30	Nobel CC 3.0	3	3
AB-NBA43	Nobel CC RP	3.9	4.3 & 5
AB-NBA60	Nobel CC WP	5.1	5.5
AB-SBO33	Straumann BoneLevel NC	3.3	3.3
AB-SBO41	Straumann BoneLevel RC	4.1 & 4.8	4.1 & 4.8

Table	1.

All digitally designed CAD/CAM customizations for the Elos Accurate® Customized Abutments are only intended to be sent and manufactured at a FDA registered Elos Medtech approved milling facility.

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IX. Summary of the Technological Characteristics:

The subject devices provide additional restorative options for connection to existing implant platforms. The subject devices has similar Indications for Use, intended use, designs, sizes and configurations, materials, and principles of operation as the primary predicate device Elos Accurate® Customized Abutment (K171799 / SE 01/15/2018). 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 are not identical. However, the subject device and corresponding primary predicates are all abutments intended for use with endosseous dental implants for support of single-tooth or multiple-tooth restorations in the upper or lower arch, and therefore, have the same intended use. Also, for the subject device, all digitally designed abutments are intended to be manufactured at an Elos Medtech approved milling facility which is equivalent to the predicate device. The implant system compatibility of the subject device is extended to include compatibility other implant platforms. All differences between the subject- and predicate devices are further specified in the 4 bullets below. The 4 bullets have been substantiated by engineering and dimensional analysis of original manufactures' components (abutments, implants & abutment screws) for determination of compatibility (bullet 1), fatigue testing (bullet 1, 2 and 3) and additional biocompatibility cytotoxicity testing (bullet 4).

. The implant system compatibility of the subject device is extended to include Nobel Replace NP, Nobel CC; 3.0, RP and WP and Straumann Bone Level NC and RC platforms.
The subject device allows an angulation up to 30° compared to the primary predicate device that allows an angulation up to 20°.
. Minimum wall thickness is 0.4mm for subject device compared to 0.5mm for the primary predicate
. Subject devices includes a non-coated prosthetic screw

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Element of Comparison	Indications for Use
Subject DeviceElos Accurate® CustomizedAbutment	The Elos Accurate® Customized Abutments are intended for attaching todental implants in order to provide basis for single or multiple toothprosthetic restorations. The Elos Accurate® Customized Abutment will beattached to a dental implant using the included Elos Prosthetic screw.The Elos Accurate® Customized Abutments are compatible with the implantsystems listed in table 1:
	Table 1.Elos AccurateCustomized Abutment- Model Type	Platformcompatibility	Platformdiameter[mm]	ImplantBodydiameter[mm]
	AB-NBR35	Nobel ReplaceNP	3.5	3.5
	AB-NBA30	Nobel CC 3.0	3	3
	AB-NBA43	Nobel CC RP	3.9	4.3 & 5
	AB-NBA60	Nobel CC WP	5.1	5.5
	AB-SBO33	Straumann BoneLevel NC	3.3	3.3
	AB-SBO41	Straumann BoneLevel RC	4.1 & 4.8	4.1 & 4.8
	All digitally designed CAD/CAM customizations for the Elos Accurate®Customized Abutments are only intended to be sent and manufactured at aFDA registered Elos Medtech approved milling facility.
Primary Predicate Device(K171799)Elos Accurate® CustomizedAbutment	The Elos Accurate® Customized Abutments are intended for attaching todental implants in order to provide basis for single or multiple toothprosthetic restorations. The Elos Accurate® Customized Abutment will beattached to a dental implant using the included Elos Prosthetic screw.The Elos Accurate® Customized Abutments are compatible with thefollowing implant systems:
	Ref. No.	Platform compatibility		Implantdiameter
	AB-BRA411213-US	Nobel Biocare® / Brånemark® RP		3.75 mm & 4mm
	AB-BRA351213-US	Nobel Biocare® / Brånemark® NP		3.3 mm
	AB-BRA511213-US	Nobel Biocare® / Brånemark® WP		5 mm
	All digitally designed Elos Accurate® Customized Abutments are intended tobe manufactured at an Elos Medtech approved milling facility.

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Element of Comparison	Subject DeviceElos Accurate® Customized Abutment	Primary Predicate Device (K171799)Elos Accurate® Customized Abutment
FDA Classification & Product Code	21 CFR 872.3630: NHAEndosseous Dental Implant Abutment	21 CFR 872.3630: NHAEndosseous Dental Implant Abutment
Base Materials	Elos Accurate® Customized Abutments:Titanium Alloy 6Al-4V ELI, medical grade 5Elos Prosthetic screws:Titanium Alloy 6Al-4V ELI, medical grade 5	Elos Accurate® Customized Abutments:Titanium Alloy 6Al-4V ELI, medical grade 5Elos Prosthetic screws:Titanium Alloy 6Al-4V ELI, medical grade 5
Surface Finish	Elos Accurate® Customized Abutment:Non-coatedElos Abutment screws:Non-coated or MediCarb (DLC)	Elos Accurate® Customized Abutment:Non-coatedElos Abutment screws:MediCarb (DLC)
Implant interface	Indexed	Indexed
Connection type	Flat top and conical	Flat top
Abutment diameter	Ø3.0 - Ø6.0 mm	Ø3.5 - Ø5.1 mm
Prosthesis attachment	Cement-retained	Cement-retained
Restoration	Single-unit &Multi-unit	Single-unit &Multi-unit
Abutment Design Matrix	Up to 30°	Up to 20°
Sterility	Provided non-sterile	Provided non-sterile
Sterilization method	Steam sterilization	Steam sterilization
Digital CAD Systems	510(k) cleared CAD software	510(k) cleared CAD software
Abutment Design Matrix	Minimum wall thickness: 0.4 mmMaximum post height: 13 mmMaximum angulation: 30°Maximum diameter: 12 mmMinimum post height: 4mmMinimum gingiva height: 0.5mmMaximum gingiva height: 5mm	Minimum wall thickness: 0.5 mmMaximum post height: 13 mmMaximum angulation: 20°Maximum diameter: 12 mmMinimum post height: 4mmMinimum gingiva height: 0.5mmMaximum gingiva height: not stated

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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 included:

engineering and dimensional analysis of original manufactures' components (abutments, implants & abutment screws) for determination of compatibility.
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.
biocompatibility testing for cytotoxicity according to ISO 10993-5. Tests included covered: ●
- non-coated prosthetic screw representative for subject device -
- -Medicarb coated prosthetic screw representative for subject devices (test of primary predicate device (K171799))
- -Elos accurate® Customized Abutment representative for subject devices (test of primary predicate device (K171799))

As the primary predicate device were tested according to ISO 17665-1 & ISO 17665-2, demonstrating a SAL of 10th no additional testing were necessary on the subject device.

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.

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.)