s-Clean Pre-Milled Abutment Mini is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.

All digitally designed abutments for use with s-Clean Pre-Milled Abutment Mini are intended to be manufactured at a Dentis validated milling center.

Device Description

Patient-specific abutment is made from titanium alloy conforming to ASTM F136 titanium abutment to be used in fabricating patient-specific abutments. The subject abutments are indicated for cemented or "Screw-and Cement-Retained Prosthesis(SCRP)" restorations. Each patient-specific abutment is individually prescribed by the clinician.

The diameters of patient-specific abutment are 5.8, 6.8mm and two connection designs (Hex, Non-hex).

s-Clean Pre-Milled Abutment Mini are supplied with s-Clean abutment screw Mini, previously cleared in K210080 and provided non-sterile.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a dental device, the "s-Clean Pre-Milled Abutment Mini." It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of the device's performance against specific acceptance criteria in the context of a diagnostic or AI-driven system.

Therefore, many of the requested details about acceptance criteria, study design for performance, sample sizes, expert qualifications, and ground truth establishment are not applicable or available in this document. This is because the device is a dental abutment, not a diagnostic or AI-powered system that requires performance metrics like sensitivity, specificity, or human reader improvement.

However, I can extract information related to the device's testing and the conclusion of its substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

For a physical device like a dental abutment, "acceptance criteria" typically refer to meeting specified engineering and materials standards, rather than diagnostic performance metrics. The "performance" is demonstrated by passing these tests.

Acceptance Criteria (Standards)	Reported Device Performance
Fatigue Resistance: ISO 14801:2016 (Determination of dynamic fatigue properties of endosseous dental implants)	The subject device underwent fatigue tests under a worst-case scenario according to ISO 14801:2016. The results met the criteria of the standards and demonstrated substantial equivalence with the predicate device.
Biocompatibility: ISO 10993-1:2009 (Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process)	Biocompatibility testing for predicate devices (referenced in K200099) was leveraged for the subject device.
Sterilization Validation: ANSI/AAMI ST79, ISO 17665-1, ISO 17665-2, ISO 11737-1, ISO 11737-2, and ISO 11138-1	End User Sterilization Validation Test Report for predicate devices (referenced in K111364) was leveraged. A worst-case evaluation showed that the previously cleared device was able to be leveraged for the steam sterilization of the subject device. The subject device is supplied non-sterile and requires steam sterilization by the user.
FDA Guidance Compliance: "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments"	Non-clinical test data was conducted in accordance with the recommendations of this FDA Guidance, consisting of testing finished assembled implant/abutment systems of the worst-case scenario (smallest diameter with maximum angulation) through fatigue testing. The results of the tests met the criteria of the standards and demonstrated substantial equivalence with the predicate device.

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

The document does not specify a distinct "test set" in the way a diagnostic study would. For the fatigue testing, it refers to "the worst-case scenario" (smallest diameter with maximum angulation) but does not provide the specific number of units tested. The provenance of this data is from the manufacturer's (Dentis Co., Ltd.) non-clinical testing, which is implicitly prospective testing done for the 510(k) submission.

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

Not applicable. This device is a physical dental abutment, not a diagnostic tool requiring expert interpretation or ground truth establishment.

4. Adjudication method for the test set

Not applicable. There is no diagnostic "test set" or human interpretation involved to require an adjudication method.

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 is not an AI-assisted diagnostic device.

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

Not applicable. This is not an algorithmic device.

7. The type of ground truth used

For a physical medical device, "ground truth" would refer to its adherence to engineering specifications and material properties, validated through physical testing against established technical standards (like ISO or ASTM standards) rather than expert consensus on diagnostic images or pathology. The "ground truth" here is compliance with these standards.

8. The sample size for the training set

Not applicable. This is a physical device, not a machine learning model.

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

Not applicable. There is no training set for a machine learning model. The "ground truth" for the device's design and manufacturing is established by adherence to recognized engineering standards and quality control processes.

Summary

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

Re: K210410

Trade/Device Name: s-Clean Pre-Milled Abutment Mini Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: June 10, 2021 Received: June 15, 2021

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) K210410

Device Name s-Clean Pre-Milled Abutment Mini

Indications for Use (Describe)

s-Clean Pre-Milled Abutment Mini is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.

All digitally designed abutments for use with s-Clean Pre-Milled Abutment Mini are intended to be manufactured at a Dentis validated milling center.

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)

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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

Device Information

● Trade Name: s-Clean Pre-Milled Abutment Mini

Common Name: Dental Abutment System
Classification Name: Endosseous dental implant abutment
Product Code: NHA
Panel: Dental
Regulation Number: 872.3630
Device Class: Class II ●
. Date prepared: 09/09/2021

Predicate Devices:

Primary Predicate K181037, DIO CAD/CAM Abutment by DIO CORPORATION

Reference Device K200099, s-Clean SQ-SL Implant System Mini by Dentis Co., Ltd. K111364, Haptite Coating Implant System by Dentis Co., Ltd.

Indications for Use:

s-Clean Pre-Milled Abutment Mini is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.

All digitally designed abutments for use with s-Clean Pre-Milled Abutment Mini are intended to be manufactured at a Dentis validated milling center.

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

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Device Description:

The diameters of patient-specific abutment are 5.8, 6.8mm and two connection designs (Hex, Non-hex).

Patient-Specific Abutment is compatible with following Implant Systems:

Proprietary Name	Dentis s-Clean s-Line Mini
Compatible Implants (K number)	K210080
Implant diameter size	5.8/6.8
Implant Interface Connection Type/Size (mm)	Internal Connection type / 2.1
Type of Implant-Abutment Connection	Hex/Non-Hex

s-Clean Pre-Milled Abutment Mini are supplied with s-Clean abutment screw Mini, previously cleared in K210080 and provided non-sterile.

Materials:

. s-Clean Pre-Milled Abutment Mini and s-Clean Abutment Screw s-Line Mini is fabricated from Ti-6Al-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 connection interfaces to the implants are identical diameter and connection type. Comparison demonstrating Substantial Equivalence follows:

	Subject Device	Primary Predicate Device
Applicant	Dentis Co., Ltd.	DIO Corporation
Trade Name	s-Clean Pre-Milled Abutment Mini	DIO CAM/CAM Abutment
510(k) No.	Not yet assigned	K181037
Classification Name	Endosseous Dental Implant, Abutment (872.3630)	Endosseous Dental Implant, Abutment (872.3630)
Product Code	NHA	NHA
Class	II	II
Material	Ti-6AL-4V ELI (ASTM F136)	Ti-6AL-4V ELI (ASTM F136)
Diameter (mm)	CAD/CAM Patient-Specific Abutment: 5.8/6.8	CAD/CAM Patient-Specific Abutment: 3.0/3.3/3.8/4.0/4.5/5.0/5.5/6.0/6.5/7.0
Sterile	Steam Sterilization by user(Provided Non-Sterile)	Steam Sterilization by user(Provided Non-Sterile)
Type of Retention	Screw-retained or cement retained	Screw-retained or cement retained
Abutment Seat	Sits on Taper	Sits on Taper
Anatomical Site	Oral Cavity	Oral Cavity
Constructions	Machined	Machined
	s-Clean Pre-Milled Abutment Mini is intended for use with dentalimplants as a support for single or multiple tooth prostheses in the maxillaor mandible of a partially or fully edentulous patient.		DIO CAD/CAM Abutment is intended for use with dental implants as asupport for single or multiple tooth prostheses in the maxilla or mandible ofa partially or fully edentulous patient.
Indications For Use/Intended Use	All digitally designed abutments for use with s-Clean Pre-MilledAbutment Mini are intended to be manufactured at a Dentis validatedmilling center.	Implant SystemCompatibility	Implant Diameter(mm)
		UF(II) NarrowImplant System	3.0/3.3
		UF Sub mergedImplant System	3.8/4.0/4.5/5.0/5.5/6.0/6.5/7.0
			Platform Diameter(mm)
			3.0/3.3
			3.8/4.0/4.5/5.0/5.5/6.0/6.5/7.0

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K210410

		UF(II) ImplantSystem		3.8/4.0/4.5/5.0/5.5	3.8/4.0/4.5/5.0/5.5
		Patient specific abutment is intended for use with the UF implant systemsprovided in the chart. All digitally designed abutments for use with DIOCAD/CAM Abutments are intended to be manufactured at a DIOCorporation validated milling center.
SubstantialEquivalenceComparison		The subject patient specific abutment is substantially equivalent in designs, dimensions, material, indications, abutment seat, screw seat,anatomical site, connection, and technological characteristics with the identified primary predicate device. The patient specific abutmentis similar in fundamental scientific technology to the predicate.The Indications for Use of the subject and primary predicate device are identical other than the compatible implant bodies. Thisdifference is mitigated by fatigue testing, and identification of reference device for compatible implant bodies. Both the predicate andsubject devices are intended to be milled into patient specific abutments using CAD/CAM technology under the manufacturing controlof the sponsor. Any differences in technology characteristics are accompanied by information that demonstrated the device issubstantially equivalent as the predicate.

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Non-Clinical Testing

The subject device was tested to evaluate its substantial equivalence according to the following standards.

Fatigue Tests on subject device under the worst-case scenario according to ISO 14801:2016 .
Below tests were performed for predicate devices and leveraged for the subject device:
Biocompatibility testing according to ISO 10993-1:2009 abutments referenced in K200099 ●
. 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 A worst-case evaluation showed that the previously cleared device was able to be leveraged for the steam sterilization of the subject device

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 the recommendations of FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments", and it consisted of testing finished assembled implant/abutment systems of the worstcase scenario, (smallest diameter with maximum angulation) through fatigue testing.

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

Conclusion

The s-Clean Pre-Milled 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 s-Clean Pre-Milled 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.)