The Dentis s-Clean Abutment Mini is an endosseous dental implant that is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple-units prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.

Device Description

Dentis s-Clean Abutment Mini is composed of Abutments are made of Ti-6AI-4V ELI according to ASTM F136 and Cobalt-28Chromium-6Molybdenum Alloy ASTM F1537. The s-Clean O-Ring Abutment s-Line and s-Clean TiN Half Coating Sub-Octa Abutment is screw assembled design but s-Clean CCM UCLA Abutment s-Line is screw separation design. The s-Clean TiN Half Coating Sub-Octa Abutment is always to be combined with a casting abutment (e.g., Gold Cylinder) or burn-out plastic sleeve for single-unit loading. The minimum post height of s-Clean TiN Half Coating Sub-Octa Abutment when combined with casting abutment (e.g., Gold Cylinder) or burn-out plastic sleeve for single-unit loading is 4mm. The minimum post height of s-Clean CCM UCLA Abutment s-Line for single-unit loading is 4mm. The Subject device is compatible with implants cleared in K210080. Compatible fixture diameters are Ø5.8. 6.8 and Ø7.8 and lengths are 7.5. 9.5, 11.4 and 11.5mm. Compatible fixture, K210080, has dual screw-joint (structured with Upper and Lower screw joint) and a hex anti-rotation design connection. As explained in K210080, there are two-screw-joint features, 1.6M screw (Lower part) or 2.0M Screw (Upper Part) for diverse screw connection with other abutments. s-Clean O-Ring Abutment s-Line and s-Clean TiN Half Coating Sub-Octa Abutment have Upper M2.0 Screw and s-Clean CCM UCLA Abutment s-Line has Lower M1.6 screw. When dividing screw assemble design, screw assembled one-piece abutment is connected with upper screw and screw separated twopiece abutment is connected with lower screw.

AI/ML Overview

The Dentis s-Clean Abutment Mini is an endosseous dental implant system, and the provided document is a 510(k) summary for its FDA clearance. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than providing a standalone study with specific acceptance criteria and performance data for the subject device itself. Therefore, much of the requested information regarding acceptance criteria, performance data, sample sizes, expert ground truth, and specific study types (MRMC, standalone) as typically described for AI/ML device evaluations is not applicable or available in this kind of regulatory submission.

Instead, the document asserts substantial equivalence based on:

Similarities in intended use, materials, and product specifications with predicate devices.
Leveraging non-clinical testing data from predicate devices for biocompatibility and sterilization, as the materials and manufacturing processes are considered equivalent.
Scientific rationale and literature review for MRI safety, rather than new testing.

Here's a breakdown of the provided information relative to your request:

1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the context of specific performance metrics for the Dentis s-Clean Abutment Mini against defined acceptance criteria. The regulatory approval is based on demonstrating that the device is substantially equivalent to predicate devices already on the market, implying that it meets the accepted safety and effectiveness standards without necessarily requiring new, specific performance studies for this particular submission.

The document highlights the following characteristics of the subject devices (Dentis s-Clean Abutment Mini: s-Clean O-Ring Abutment s-Line, s-Clean TiN Half Coating Sub-Octa Abutment, and s-Clean CCM UCLA Abutment s-Line) and compares them to predicate devices:

Characteristic	Subject Device Performance (Dentis s-Clean Abutment Mini)	Predicate Device (K171027, K161244, K210080)	Acceptance Criteria/Comparison Summary
Material (s-Clean O-Ring Abutment s-Line & s-Clean TiN Half Coating Sub-Octa Abutment)	Ti-6Al-4V ELI (ASTM F136)	Ti-6Al-4V ELI (ASTM F136)	Same material, implying equivalent biocompatibility and mechanical properties.
Material (s-Clean CCM UCLA Abutment s-Line)	Cobalt-28Chromium-6Molybdenum Alloy (ASTM F1537)	Cobalt-28Chromium-6Molybdenum Alloy (ASTM F1537)	Same material, implying equivalent biocompatibility and mechanical properties.
Sterilization	End User Sterilization	End User Sterilization	Same sterilization method, leveraging predicate device sterilization validation.
Intended Use	Indicated for surgical placement in upper and lower jaw arches, to provide a root form means for single or multiple-units prosthetic appliance attachment to restore a patient's chewing function. Two-stage or single-stage (immediate loading) surgical processes.	Identical or substantially similar indications for use.	Same indications for use.
Dimensions (Example: s-Clean O-Ring Abutment s-Line)	Diameter: Ø4.5 mm; Length: 10.71 and 12.71 mm	Diameter: Ø3.4 and Ø4.5 mm; Length: 10.1, 11.6 and 13.6 mm	Difference in specific dimensions, but stated not to affect fundamental functions and safety, establishing substantial equivalence.
Dimensions (Example: s-Clean TiN Half Coating Sub-Octa Abutment)	Diameter: Ø4.8 mm; Length: 8.16, 8.66, 9.66, 10.66, 11.66 and 12.66 mm	Diameter: Ø4.8 mm; Length: 9.15, 9.65, 10.65, 11.65, 12.65 and 13.65 mm	Difference in specific lengths, but stated not to affect fundamental functions and safety.
Dimensions (Example: s-Clean CCM UCLA Abutment s-Line)	Diameter: Ø4.0 mm; Gingival Height: 1mm and 3mm	Diameter: Ø4.5 mm; Gingival Height: 1mm and 3mm (for predicate K171027)	Difference in diameter, supported by reference device (K161244) with similar diameter, demonstrating substantial equivalence.
Surface Treatment (s-Clean TiN Half Coating Sub-Octa Abutment)	TiN Coating	TiN Coating	Same surface treatment.
MR Environment Condition	Non-clinical worst-case MRI review performed using scientific rationale and published literature.	-	Based on scientific rationale and published literature for material composition; considered safe in MR environment.

2. Sample size used for the test set and the data provenance
Not applicable/Not provided. This document does not describe a new clinical or non-clinical test set specifically for the Dentis s-Clean Abutment Mini for performance evaluation against acceptance criteria. The approach relies on substantial equivalence to predicate devices and leveraging existing data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. No specific "test set" with expert-established ground truth is described for this submission, as it focuses on demonstrating equivalence rather than proving new performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not provided. As there's no defined test set for performance, adjudication methods are not relevant here.

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
Not applicable. This device is a physical dental implant abutment, not an AI/ML diagnostic or assistive software. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical component, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable/Not provided. No new ground truth data was established for performance evaluation of the subject device in this submission. The "ground truth" for the clearance is the established safety and effectiveness of the legally marketed predicate devices.

8. The sample size for the training set
Not applicable. This device is a physical product, not an AI/ML model that requires training data.

9. How the ground truth for the training set was established
Not applicable. This device is a physical product, not an AI/ML model that requires training data.

Summary of the Study (Compliance with Standards and Leveraged Data):

The "study" described in this 510(k) submission is primarily a non-clinical review and comparison to predicate devices, leveraging previously established data and scientific rationale.

Biocompatibility Testing: Performed for predicate devices and "leveraged for the subject device" because the materials (Ti-6Al-4V ELI and Cobalt-28Chromium-6Molybdenum Alloy) and manufacturing processes are substantially equivalent. Tests were conducted according to ISO 10993-1:2009.
End User Sterilization Validation Test Report: Performed for predicate devices (K210080 for Ti-6Al-4V, K161244 for Cobalt-28Chrominum-6Molybdenum, and K171027 for Ti-6Al-4V with TiN Coating) and "leveraged for the subject device." Tests were conducted according to ANSI/AAMI ST79, ISO 17665-1, ISO 17665-2, ISO 11737-1, ISO 11737-2, and ISO 11138-1. The report also mentions a test article for Cobalt-27Chrominum-6Molybdenum that was the "largest surface area among the devices that have the same manufacturing process and material," likely representing a worst-case scenario.
Fatigue Testing: Not performed for the subject device itself, as it does not include angled abutments. This decision is based on FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments," which states fatigue testing is not necessary for systems without angled abutments.
Surface Modification Information: Not tested or provided for the subject device because it was "provided in the predicate devices and can be leveraged for the subject device," implying similar surface characteristics.
MR Environment Condition: A non-clinical worst-case MRI review was performed. This involved evaluating the device's components (materials) against scientific rationale and published literature (e.g., Woods, Terry O., et al., 2019) to assess magnetically induced displacement force and torque. The FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment" was referenced.
Clinical Testing: This was explicitly stated as "not necessary to establish substantial equivalency of the device."

In conclusion, this regulatory submission focuses on demonstrating substantial equivalence through a rigorous comparison of the subject device's features (materials, dimensions, intended use, sterilization, surface treatment) to already-cleared predicate devices, coupled with leveraging existing non-clinical test data and scientific literature for safety aspects. It is not a performance study in the sense of establishing new acceptance criteria and demonstrating achievement through new testing specific to the subject device alone.

Summary

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Dentis Co., Ltd. % April Lee Consultant Withus Group Inc 106 Superior Irvine, California 92620

Re: K220440

Trade/Device Name: Dentis s-Clean Abutment Mini Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: May 14, 2022 Received: May 17, 2022

Dear April Lee:

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.

Andrew I Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K220440

Device Name Dentis s-Clean Abutment Mini

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
✓ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

Submitter

Dentis Co., Ltd. Gyu Ri Kim 99, Seongseoseo-ro, Dalseo-gu Daegu, 42718 Korea Email: kgr1026@dentis.co.kr Tel. +82-53-589-3541 Fax. +82-53-289-7922

Official Correspondent

Withus Group Inc. April Lee 106 Superior, Irvine, CA 92620 USA Email: withus6664@gmail.com Phone: 1-909-274-9971 Fax: 1-909-460-8122

Device Information

. Trade Name: Dentis s-Clean Abutment Mini
. Common Name: Endosseous dental implant abutment
Classification Name: Endosseous dental implant abutment ●
. Product Code: NHA
Panel: Dental
Regulation Number: 872.3630
Device Class: Class II
Date prepared: 06/15/2022 ●

Predicate Devices:

Primary Predicate K171027, Dentis Dental Implant System by Dentis Co., Ltd

Reference Device K161244, s-Clean OneQ-SL Narrow Implant System by Dentis Co., Ltd. K210080, Dentis s-Clean s-Line Mini by Dentis Co., Ltd.

Indication for Use:

Device Description:

The s-Clean TiN Half Coating Sub-Octa Abutment is always to be combined with a casting abutment (e.g., Gold Cylinder) or burn-out plastic sleeve for single-unit loading. The minimum post height of s

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Clean TiN Half Coating Sub-Octa Abutment when combined with casting abutment (e.g., Gold Cylinder) or burn-out plastic sleeve for single-unit loading is 4mm. The minimum post height of s-Clean CCM UCLA Abutment s-Line for single-unit loading is 4mm.

The Subject device is compatible with implants cleared in K210080. Compatible fixture diameters are Ø5.8. 6.8 and Ø7.8 and lengths are 7.5. 9.5, 11.4 and 11.5mm.

Compatible fixture, K210080, has dual screw-joint (structured with Upper and Lower screw joint) and a hex anti-rotation design connection. As explained in K210080, there are two-screw-joint features, 1.6M screw (Lower part) or 2.0M Screw (Upper Part) for diverse screw connection with other abutments. s-Clean O-Ring Abutment s-Line and s-Clean TiN Half Coating Sub-Octa Abutment have Upper M2.0 Screw and s-Clean CCM UCLA Abutment s-Line has Lower M1.6 screw. When dividing screw assemble design, screw assembled one-piece abutment is connected with upper screw and screw separated twopiece abutment is connected with lower screw.

No.	Device Name	Diameter X Total Length	Angulation
1	s-Clean O-Ring Abutment s-Line	$\varnothing$ 4.5 X 10.71 and 12.71mm	0°
2	s-Clean TiN Half Coating Sub-Octa Abutment	$\varnothing$ 4.8 X 8.16, 8.66, 9.66, 10.66, 11.66 and 12.66mm	0°
3	s-Clean CCM UCLA Abutment s-Line	$\varnothing$ 4.0 X 1, 3mm (Gingival Height)	0°

The dimensions of abutments are as following:

The Abutments have below featured:

Name	Uses	Surface	Connection
s-Clean O-Ring Abutments-Line	It is used to retain an overdenture prosthetics.	N/A	Screw retain
s-Clean TiN Half CoatingSub-Octa Abutment	This Abutment is connected with fixture and itsupports prosthesis which restore tooth function.	TiN Coating	Screw retain
s-Clean CCM UCLA Abutments-Line	This Abutment is connected with fixture and itsupports prosthesis which restore tooth function.	N/A	Screw retain

Materials:

. s-Clean O-Ring Abutment s-Line and s-Clean TiN Half Coating Sub-Octa Abutment is fabricated from Ti-6A1-4V ELI (Conforming to ASTM Standard F136).
S-Clean CCM UCLA Abutment s-Line is fabricated from Cobalt-28Chromium-6Molybdenum . Alloy (Conforming to ASTM F1537)
CCM UCLA s-Line Abutment Screw is fabricated from Ti-6A1-4V ELI (Conforming to ASTM Standard F136).

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Summaries of Technology Characteristics

The subject device is substantially equivalent to the current cleared devices. They are substantially equivalent in intended use, material and product spec as diameter and length. Comparison demonstrating Substantial Equivalence follows:

1. s-Clean O-Ring Abutment s-Line

	Subject Device	Primary Predicate
Applicant	Dentis Co., Ltd.	Dentis Co., Ltd.
Trade Name	Dentis s-Clean Abutment Mini	Dentis Dental Implant System
510(k) No.		K171027
ClassificationName	Endosseous Dental Implant	Endosseous Dental Implant
Product Code	NHA	DZE, NHA
Description	Image: Dentis s-Clean Abutment Mini	Image: Dentis Dental Implant System
Material	Ti-6Al-4V ELI (ASTM F136)	Ti-6Al-4V ELI (ASTM F136)
Diameter (mm)	$\text{\O}4.5$	$\text{\O}3.4$ and $\text{\O}4.5$
Length (mm)	10.71 and 12.71	10.1, 11.6 and 13.6
Sterile	End User Sterilization	End User Sterilization
Indications ForUse	The Dentis s-Clean Abutment Mini is an endosseousdental implant that is indicated for surgicalplacement in the upper and lower jaw arches, toprovide a root form means for single or multiple-units prosthetic appliance attachment to restore apatient's chewing function. Implants can be placedwith a conventional two stage surgical process withan option for transmucosal healing or they can beplaced in a single stage surgical process forimmediate loading when good primary stability hasbeen achieved and with appropriate occlusal loading.	The Dentis Dental Implant System is anendosseous dental implant that is indicated forsurgical placement in the upper and lower jawarches, to provide a root form means for single ormultiple-units prosthetic appliance attachment torestore a patient's chewing function. Implantscan be placed with a conventional two stagesurgical process with an option for transmucosalhealing or they can be placed in a single stagesurgical process for immediate loading whengood primary stability has been achieved andwith appropriate occlusal loading.
SubstantialEquivalenceComparison	The subject device has same indications for Use, fundamental scientific technology, principle ofoperation, technology, functions, and materials and has similar design with the primary predicate.The difference between the subject and primary predicate is the Dimensions of the device and thecompatible implant body. The subject device's diameter( $\text{\O}2.88$ ) with length (9.11mm) is smaller sizethan the primary predicate but doesn't affect device's fundamental functions and safety; therefore, it issubstantial equivalent.

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	Subject Device	Primary Predicate		Subject Device	Primary Predicate Device	Reference Device
Applicant	Dentis Co., Ltd.	Dentis Co., Ltd.	Applicant	Dentis Co., Ltd.	Dentis Co., Ltd.	Dentis Co., Ltd.
Trade Name	Dentis s-Clean Abutment Mini	Dentis Dental Implant System	Trade Name	Dentis s-Clean Abutment Mini	Dentis Dental Implant System	s-Clean OneQ-SL Narrow ImplantSystem
510(k) No.	-	K171027	510(k) No.	-	K171027	K161244
ClassificationName	Endosseous Dental Implant	Endosseous Dental Implant	ClassificationName	Endosseous Dental Implant	Endosseous Dental Implant	Endosseous Dental Implant
Product Code	NHA	DZE, NHA	Product Code	NHA	DZE, NHA	DZE, NHA
Description	Image: Dentis s-Clean Abutment Mini	Image: Dentis Dental Implant System	Class	Class II	Class II	Class II
Material	Ti-6Al-4V ELI (ASTM F136)	Ti-6Al-4V ELI (ASTM F136)	Description
Diameter (mm)	Ø4.8	Ø4.8	Material	Cobalt-28Chromium-6MolybdenumAlloy(ASTM F1537)	Cobalt-28Chromium-6Molybdenum Alloy(ASTM F1537)	Cobalt-28Chromium-6MolybdenumAlloy(ASTM F1537)
Length (mm)	8.16, 8.66, 9.66, 10.66, 11.66 and 12.66	9.15, 9.65, 10.65, 11.65, 12.65 and 13.65	Diameter (mm)	$Ø4.0$	$Ø4.5$	$Ø4.0$
Surface Treatment	TiN Coating	TiN Coating	Gingival Height	1mm and 3mm	1mm and 3mm	1mm
Sterile	End User Sterilization	End User Sterilization	Sterile	End User Sterilization	End User Sterilization	End User Sterilization
Indications ForUse	The Dentis s-Clean Abutment Mini is an endosseousdental implant that is indicated for surgical placementin the upper and lower jaw arches, to provide a rootform means for single or multiple-units prostheticappliance attachment to restore a patient's chewingfunction. Implants can be placed with a conventionaltwo stage surgical process with an option fortransmucosal healing or they can be placed in a singlestage surgical process for immediate loading whengood primary stability has been achieved and withappropriate occlusal loading.	The Dentis Dental Implant System is anendosseous dental implant that is indicated forsurgical placement in the upper and lower jawarches, to provide a root form means for single ormultiple-units prosthetic appliance attachment torestore a patient's chewing function. Implants canbe placed with a conventional two stage surgicalprocess with an option for transmucosal healing orthey can be placed in a single stage surgicalprocess for immediate loading when good primarystability has been achieved and with appropriateocclusal loading.	Indications ForUse/Intended Use	The Dentis s-Clean Abutment Miniis an endosseous dental implant thatis indicated for surgical placementin the upper and lower jaw arches,to provide a root form means forsingle or multiple-units prostheticappliance attachment to restore apatient's chewing function.Implants can be placed with aconventional two stage surgicalprocess with an option fortransmucosal healing or they can beplaced in a single stage surgicalprocess for immediate loading whengood primary stability has beenachieved and with appropriateocclusal loading.	The Dentis Dental ImplantSystem is an endosseous dentalimplant that is indicated forsurgical placement in the upperand lower jaw arches, to providea root form means for single ormultiple-units prostheticappliance attachment to restorea patient's chewing function.Implants can be placed with aconventional two stage surgicalprocess with an option fortransmucosal healing or theycan be placed in a single stagesurgical process for immediateloading when good primarystability has been achieved andwith appropriate occlusalloading.	The s-Clean OneQ-SL NarrowImplant System is indicated foruse in partially or fully edentulousmandibles and maxillae, in supportof single or multiple-unitrestorations including; cemented,retained, screw retained, oroverdenture restorations, andterminal or intermediate abutmentsupport for fixed bridgework. Thissystem is dedicated for one andtwo stage surgical procedures andnot dedicated for immediateloading. This system is intendedfor delayed loading. Only, s-CleanOneQ-SL Narrow fixture (3.0, 3.3,3.7mm) is limited to replacementof maxillary lateral incisors andmandibular incisors.
SubstantialEquivalenceComparison	The subject device has same indications for Use, fundamental scientific technology, principle of operation,technology, functions, and materials and has similar design with the primary predicate.The difference between the subject and primary predicate is the lengths of the device and the compatibleimplant body. The subject device has shorter size than the primary predicate but doesn't affect device'sfundamental functions and safety; therefore, it is substantial equivalent.		SubstantialEquivalenceComparison	The subject device has same indications for Use, fundamental scientific technology, principle of operation,technology, functions, and materials and has similar design with the primary predicate.The difference between the subject and primary predicate is the diameter of the device and the compatibleimplant body. To support this discrepancy, K161244 was added; therefore, it is substantial equivalent.

2. s-Clean TiN Half Coating Sub-Octa Abutment

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3. s-Clean CCM UCLA Abutment s-Line

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Non-Clinical Testing

Below tests were performed for predicate devices and leveraged for the subject device:

Biocompatibility testing according to ISO 10993-1:2009 for Ti-6A1-4V material abutments . referenced in K210080, for Cobalt-28Chrominum-6Molybdenum material abutment referenced in K161244 and for Ti-6Al-4V with TiN Coating abutments referenced in K171027
End User Sterilization Validation Test Report according to ANSI/AAMI ST79, ISO 17665-1, ● ISO 17665-2. ISO 11737-1, ISO 11737-2, and ISO 11138-1 referenced in K111364 for Ti-6Al-4V material abutments non-coating and TiN-Coating.

The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the predicate device.

Non-clinical test data was conducted in accordance with FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments".

Biocompatibility testing for Ti-6AI-4V wth TiN Coating material abutments was conducted on the predicate device, K171027 and can be leveraged for the subject device because both devices have same material and manufacturing process which is substantially equivalent.

Fatigue testing was not performed for the subject device according to the ISO 14801:2016 because this subject device system does not include any angled abutments. Based on the FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments", the fatigue testing is not necessary if the system does not consist of angled abutments. Also, the surface modification for the subject device was not tested or provided because the surface modification information was provided in the predicate devices and can be leveraged for the subject device.

End User Sterilization Validation Test Report for Cobalt-27Chrominum-6Molybdenum was conducted on the device that is not cleared by FDA. The test article is the largest surface area among the devices that have the same manufacturing process and material.

Clinical testing was not necessary to establish substantial equivalency of the device.

MR Environment Condition -
Non-clinical worst-case MRI review was performed to evaluate the Dentis s-Clean Abutment Mini in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan. "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795), based on the entire system including all variations (all compatible implant bodies, dental abutments, and fixation screws) and material composition. Rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque

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Conclusion

Dentis s-Clean Abutment Mini constitutes a substantially equivalent medical device, meeting all the declared requirements of its intended use. This system has the same intended use and fundamental scientific technology as its predicate devices. Therefore, the Dentis s-Clean Abutment Mini and its predicates are substantially equivalent.

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.)