Predicate Devices

K 190299

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the physical characteristics, manufacturing process (CAD/CAM and milling), and compatibility with existing dental implant systems. There is no mention of AI or ML in the intended use, device description, or performance studies.

Therapeutic

Yes
The device is a medical prosthetic (abutment) that provides the basis for single or multiple tooth prosthetic restorations through attachment to dental implants, directly addressing a medical need or condition.

Diagnostic

No

Explanation: The device is described as a "patient specific abutment intended for attaching to dental implants in order to provide basis for single- or multiple tooth prosthetic restorations." Its function is to support prosthetic restorations, not to diagnose medical conditions or provide diagnostic information.

SaMD (Software as a Medical Device)

No

The device is a physical dental abutment made of Titanium alloy, not a software program. While it is digitally designed using CAD/CAM, the final product is a manufactured hardware component.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to provide a basis for dental prosthetic restorations by attaching to dental implants. This is a direct clinical application within the patient's body.
Device Description: The device is a patient-specific abutment made of titanium alloy, designed to be attached to a dental implant and then to a crown/coping. It is delivered nonsterile and intended for sterilization before placement in the patient. This describes a medical device used in a surgical/restorative procedure.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.

In summary, the Elos Accurate® Customized Abutment is a medical device used in dental procedures, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Elos Accurate Customized Abutment – Model Type	Platform compatibility	Platform diameter [mm]	Implant Body diameter [mm]
AB-NBR43	Nobel Replace RP	4.3	4.3
AB-NBR50	Nobel Replace WP	5	5
AB-NBR60	Nobel Replace 6.0	6	6
AB-NBA35	Nobel CC NP	3.5	3.5 & 3.75

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.

Product codes (comma separated list FDA assigned to the subject device)

NHA

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Dental implants

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Dental clinic, clinicians and laboratories

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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 (test of primary predicate device K190299)
- MediCarb coated prosthetic screw representative for subject device (test of reference predicate device K171799)
- Elos accurate® Customized Abutment representative for subject devices (test of reference predicate device (K171799))

Key results: Based on the test results and additional supporting documentation provided, the subject devices demonstrated substantial equivalence to the previously listed predicate devices.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K 190299

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K023113, K071370, K171799

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.)

Summary

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Image /page/0/Picture/0 description: The image shows 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.

January 2, 2020

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

Re: K192457

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: September 25, 2019 Received: October 4, 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 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 (1-800-638-2041 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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Traditional 510(k) Premarket Notification: Elos Accurate® Customized Abutment CONFIDENTIAL Elos Medtech Pinol A/S

INDICATIONS FOR USE

510(k) Number: K192457 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		1.
-------	--	----

| Elos Accurate
Customized
Abutment –
Model Type | Platform compatibility | Platform diameter
[mm] | Implant Body
diameter
[mm] |
|---------------------------------------------------------|------------------------|---------------------------|----------------------------------|
| AB-NBR43 | Nobel Replace RP | 4.3 | 4.3 |
| AB-NBR50 | Nobel Replace WP | 5 | 5 |
| AB-NBR60 | Nobel Replace 6.0 | 6 | 6 |
| AB-NBA35 | Nobel CC NP | 3.5 | 3.5 & 3.75 |

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__ AND/OR Over-The-Counter Use _ (Part 21 CFR 801 Subpart D) (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 December 28, 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/S
Engvej 33
DK-3330 Goerloese
Denmark |
|------|-------------------------|------------------------------------------------------------------------------------------------------------------------|
| | Contacts: | Tina Friis Poulsen
Head of Compliance
Tel: +45 27 77 11 17
E-mail: tina.poulsen@elosmedtech.com |
| | | Magnus Lynge Bergholt
Regulatory Affairs Manager
Tel: +45 48 21 64 58
E-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:

K 190299 / SE 06/26/2019 Elos Accurate® Customized Abutment .

Reference Devices:

K023113 / SE 09/26/2002 NOBEL REPLACE TIUNITE ENDOSSEOUS ● IMPLANT
K071370 / SE 08/03/2007 - NOBEL ACTIVE INTERNAL CONNECTION IMPLANT
K171799 / SE 01/15/2018 Elos Accurate® Customized Abutment ●

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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 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.

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.

| Elos Accurate
Customized
Abutment -
Model Type | Platform compatibility | Platform diameter
mm | Implant Body
diameter
mm |
|---------------------------------------------------------|------------------------|-------------------------|--------------------------------|
| AB-NBR43 | Nobel Replace RP | 4.3 | 4.3 |
| AB-NBR50 | Nobel Replace WP | 5 | 5 |
| AB-NBR60 | Nobel Replace 6.0 | 6 | 6 |
| AB-NBA35 | Nobel CC NP | 3.5 | 3.5 & 3.75 |

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 (K190299 / SE 06/26/2019). 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 identical except for implant system compatibility. The implant system compatibility of the subject device is extended to include compatibility other implant platforms. The difference in implant system compatibility have been substantiated by engineering and dimensional analysis of original manufactures' components (abutments, implants & abutment screws) for determination of compatibility and fatigue testing.

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Element of Comparison	Indications for Use
Subject Device
Elos Accurate® Customized 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:
Table 1.
Elos Accurate Customized Abutment – Model Type Platform compatibility Platform diameter [mm] Implant Body diameter [mm] AB-NBR43 Nobel Replace RP 4.3 4.3 AB-NBR50 Nobel Replace WP 5 5 AB-NBR60 Nobel Replace 6.0 6 6 AB-NBA35 Nobel CC NP 3.5 3.5 & 3.75
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.
Primary Predicate Device
(K190299)
Elos Accurate® Customized 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:
Table 1.
Elos Accurate Customized Abutment – 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 3.3 3.3 AB-SBO41 Straumann Bone Level 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.

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| Element of Comparison | Subject Device
Elos Accurate® Customized Abutment | Primary Predicate Device (K190299)
Elos Accurate® Customized Abutment |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FDA Classification & Product Code | 21 CFR 872.3630: NHA
Endosseous Dental Implant Abutment | 21 CFR 872.3630: NHA
Endosseous Dental Implant Abutment |
| Base Materials | Elos Accurate® Customized Abutments:
Titanium Alloy 6Al-4V ELI, medical grade 5

Elos Prosthetic screws:
Titanium Alloy 6Al-4V ELI, medical grade 5 | Elos Accurate® Customized Abutments:
Titanium Alloy 6Al-4V ELI, medical grade 5

Elos Prosthetic screws:
Titanium Alloy 6Al-4V ELI, medical grade 5 |
| Surface Finish | Elos Accurate® Customized Abutment:
Non-coated

Elos Abutment screws:
Non-coated | Elos Accurate® Customized Abutment:
Non-coated

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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: o
- non-coated prosthetic screw representative for subject device (test of primary । predicate device K190299)
- -Medicarb coated prosthetic screw representative for subject device (test of reference predicate device K171799)
- Elos accurate® Customized Abutment representative for subject devices (test of reference predicate device (K171799))

As the primary predicate device were tested according to ISO 17665-1 & ISO 17665-2, demonstrating a SAL of 10° 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.