The Dentis s-Clean SQ-SL Narrow Implant System is intended for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic attachment to restore a patient's chewing function. The Dentis s-Clean SQ-SL Narrow Implant System is limited to the replacement of maxillary lateral incisors and mandibular incisors. It is intended for delayed loading.

The Dentis s-Clean SQ-SL Narrow Implant System may be used as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors.

The implants may be restored immediately

with a temporary prosthesis that is not in functional occlusion,
when splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors, or
for denture stabilization using multiple implants in the anterior mandible and maxilla.

The implants may be placed in immediate function when good primary stability has been achieved and with appropriate occlusal loading.

Device Description

The Dentis s-Clean SQ-SL Narrow Implant System is used to replace missing teeth in various situations ranging from a single tooth loss to the complete loss of incisors teeth. This system is restricted to substitute the maxillary lateral incisors and mandibular incisors. It is one and two stage endosseous screw type implant with internal connection, intended for single use. Dentis s-Clean SQ-SL Narrow Implant System is a suitable treatment option when the possibility of placing a standard implant is limited due to physical conditions, where the horizontal space is limited by adjacent teeth and roots, or in situations with a narrow alveola ridge.

AI/ML Overview

The provided text is a 510(k) summary for a dental implant system. It focuses on demonstrating "substantial equivalence" to predicate devices, rather than presenting a study to prove a device meets specific performance acceptance criteria for a novel function. As such, the information required for a study proving device performance against acceptance criteria (sections 1-9 of your request) is largely absent from this type of regulatory document.

However, I can extract information related to the acceptance criteria for ensuring safety and performance based on the type of testing performed, which is primarily non-clinical (bench) testing.

Here's an attempt to answer your questions based on the provided text, highlighting where information is absent or not applicable to this type of regulatory submission:

Device: Dentis s-Clean SQ-SL Narrow Implant System

Indications for Use (from K230246): The Dentis s-Clean SQ-SL Narrow Implant System is intended for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic attachment to restore a patient's chewing function. The Dentis s-Clean SQ-SL Narrow Implant System is limited to the replacement of maxillary lateral incisors and mandibular incisors. It is intended for delayed loading.

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

The document does not provide a table of acceptance criteria with specific numerical performance metrics. Instead, it lists the types of tests performed and states that the device was found "substantially equivalent." For specific performance criteria, one would typically refer to the referenced ISO standards (e.g., ISO 14801:2016 for fatigue). The "reported device performance" is implicitly that it met the requirements of these standards.

Acceptance Criteria (General Category)	Reported Device Performance (Implicitly Met)
Mechanical/Fatigue Strength	Complies with ISO 14801:2016 (Fatigue Testing under worst-case scenario)
Biocompatibility	Complies with ISO 10993-1:2009 (leveraged from predicate devices)
Sterilization Efficacy	Complies with ANSI/AAMI ST79, ISO 17665-1,-2, ISO 11737-1,-2, and ISO 11138-1 (End User Sterilization Validation, leveraged from predicate devices)
Material Composition Equivalence	Demonstrated substantial equivalence in chemical composition between subject and predicate (specifically for TiN coating via SEM, EDS, adhesion, thickness)
MR Environment Compatibility	Assessed via non-clinical worst-case MRI review using scientific rationale and published literature per FDA guidance (magnetically induced displacement force and torque assessed)

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified for any of the tests. For fatigue testing per ISO 14801, a minimum number of samples is typically tested, but the exact number isn't provided here.
Data Provenance: Not specified, but the submission is from Dentis Co., Ltd. in Korea. The studies are described as "non-clinical test data," implying bench testing, not patient data. Therefore, "retrospective or prospective" is not applicable in the clinical trial sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is a 510(k) submission for a dental implant system, demonstrating substantial equivalence through non-clinical (bench) testing, not through expert-reviewed clinical imaging data or diagnostic performance studies. "Ground truth" in this context refers to the defined metrics and standards of the bench tests (e.g., fatigue cycles to failure, material composition analysis).

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

Not applicable. This concept applies to clinical studies involving human readers and interpretations, not to non-clinical bench 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

Not applicable. The device is a dental implant system, not an AI-powered diagnostic tool requiring human reader studies.

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

Not applicable. The device is a physical dental implant, not an algorithm.

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

The "ground truth" for this device's non-clinical testing is defined by international and national standards for material properties, mechanical performance, biocompatibility, and sterilization (e.g., ISO 14801:2016, ISO 10993-1:2009, ANSI/AAMI ST79). For the MR environment assessment, it relies on "scientific rationale and published literature."

8. The sample size for the training set

Not applicable. This is not a machine learning model.

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

Not applicable. This is not a machine learning model.

Summary of the "Study" (Non-Clinical Testing):

The "study" described in this 510(k) summary is a set of non-clinical (bench) tests designed to demonstrate that the Dentis s-Clean SQ-SL Narrow Implant System is as safe and effective as previously cleared predicate devices.

Purpose: To demonstrate substantial equivalence to predicate devices (K161244, K182194, K210080, K171027, K171694) in terms of materials, design, mechanical performance, biocompatibility, and sterilization, rather than proving performance against novel clinical acceptance criteria.
Key Tests Performed:
- Fatigue Testing: Performed on the subject device according to ISO 14801:2016 under worst-case scenarios.
- Biocompatibility Testing: Leveraged from predicate devices (K171694) and based on ISO 10993-1:2009. The rationale is that the subject device uses the same materials and manufacturing process.
- End User Sterilization Validation: Leveraged from predicate devices (K171694 and K171027) based on ANSI/AAMI ST79, ISO 17665-1,-2, ISO 11737-1,-2, and ISO 11138-1. The rationale is similar product category, material, manufacturing process, facility, and packaging.
- Surface Modification (TiN Coating): Data provided to compare chemical composition, SEM, EDS, adhesion, and thickness between subject and predicate (K171694).
- MR Environment Compatibility: Non-clinical worst-case MRI review performed based on scientific rationale and published literature, referencing FDA guidance.
Conclusion: The device "constitutes a substantially equivalent medical device, meeting all the declared requirements of its intended use," based on these non-clinical tests and comparisons to predicate devices.

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 & Human Services logo. To the right of that 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.

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

Re: K230246

Trade/Device Name: Dentis s-Clean SQ-SL Narrow Implant System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: April 28, 2023 Received: April 28, 2023

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 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.

Andrew I. Steen -S

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

Enclosure

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Indications for Use

510(k) Number (if known) K230246

Device Name Dentis s-Clean SQ-SL Narrow Implant System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CER 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) Summary

Submitter

Dentis Co., Ltd. EunJin, Shin 99, Seongseoseo-ro, Dalseo-gu Daegu, 42718 Korea Email: ej0616@dentis.co.kr Tel. +82-53-589-3646 Fax. +82-53-289-7922

Device Information

Trade Name: Dentis s-Clean SQ-SL Narrow Implant System
Common Name: Dental Implant Abutment
Classification Name: Abutment, Implant, Dental, Endosseous ●
Product Code: NHA
. Panel: Dental
Regulation Number: 872.3630
Device Class: Class II
Date Prepared: 05/25/2023

Predicate Devices:

Primary Predicate

K161244, s-Clean OneQ-SL Narrow Implant System

Reference devices

K182194, UV Active Implant System manufactured by DIO Corporation
K210080, Dentis s-Clean s-Line Mini manufactured by Dentis Co., Ltd.
K171027, Dentis Dental Implant System by Dentis Co., Ltd.
K171694, s-Clean TiN Coating Abutments by Dentis Co., Ltd.

Indication for Use:

The Dentis s-Clean SQ-SL Narrow Implant System may be used as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors.

The implants may be restored immediately

1. with a temporary prosthesis that is not in functional occlusion,
1. when splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors, or
1. for denture stabilization using multiple implants in the anterior mandible and maxilla.

The implants may be placed in immediate function when good primary stability has been achieved and with appropriate occlusal loading.

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 dimensions of abutments are as following:

No.	Device Name	Dimension Ranges	Angulation
1	s-Clean TiN Half Coating AngledAbutment (Narrow)	Ø4.0 (D) X 10.26, 10.76, 12.26 and 12.76mm (L)	15°
2	s-Clean Temporary Abutment(Narrow)	Ø4.0 (D) X 12.5, 13, 14.5 and 15mm (L)	0°

Tolerance of dimension for Abutments shall be within ± 1% range.

The Abutments have below featured:

Name	Uses	Surface	Connection
s-Clean TiN Half CoatingAngled Abutment (Narrow)	The Abutment is connected with fixture and itsupports prosthesis which restores tooth function.	TiN Coating	ScrewRetained
s-Clean Temporary Abutment(Narrow)	Arbitrarily shaped upper structure used to restoremasticatory movement temporarily by usingprosthesis made according to patient's condition	N/A	ScrewRetained

The s-Clean TiN Half Coating Angled Abutment (Narrow) and s-Clean Temporary Abutment (Narrow) intended for use with the s-Clean OneQ-SL Fixture in K161244.

The s-Clean Temporary Abutment (Narrow) is not intended to be cast at angulation or placed to provide angular correction.

Materials:

. s-Clean TiN Half Coating Angled Abutment (Narrow) is fabricated from Ti-6Al-4V ELI of ASTM F136
The s-Clean Temporary Abutment (Narrow) is fabricated from PEEK material. ●

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Summaries of Technological Characteristics & Substantial Equivalence Discussion

	Subject Device	Primary Predicate	Reference Predicate
K number	K230246	K161244	K182194
Manufacturer	Dentis Co., Ltd.	Dentis Co., Ltd.	DIO CORPORATION
Trade Name	Dentis s-Clean SQ-SL NarrowImplant System	s-Clean OneQ-SL NarrowImplant System	UV Active Implant System
Indications forUse	The Dentis s-Clean SQ-SLNarrow Implant System may beused as an artificial root structureforsingle tooth replacement ofmandibular central and lateralincisors and maxillary lateralincisors.The implants may be restoredimmediately1) with a temporary prosthesisthat is not in functionalocclusion,2) when splinted together as anartificial root structure formultiple tooth replacement ofmandibular incisors, or3) for denture stabilizationusing multiple implants in theanterior mandible and maxilla.The implants may be placed inimmediate function when goodprimary stability has beenachieved and with appropriateocclusal loading.	The s-Clean OneQ-SL NarrowImplant System may be used asan artificial root structure forsingle tooth replacement ofmandibular central and lateralincisors and maxillary lateralincisors.The implants may be restoredimmediately1) with a temporary prosthesisthat is not in functionalocclusion,2) when splinted together as anartificial root structure formultiple tooth replacement ofmandibular incisors, or3) for denture stabilizationusing multiple implants in theanterior mandible and maxilla.The implants may be placed inimmediate function when goodprimary stability has beenachieved and with appropriateocclusal loading.	The UV Active Implant System isindicated for surgical placementin the upper and lower jaw arches,to provide a rootform means for single or multipleunits' prosthetic attachment torestore a patient's chewingfunction.The narrow (Ø3.0, Ø3.3) implantis limited to the replacement ofmaxillary lateral incisors andmandibular incisors. It isintended for delayed loading.The Regular (Ø3.8 ~ Ø5.5)implants can be placed with aconventional two stage surgicalprocess with an option fortransmucosal healing or they canbe placed in a single stagesurgical process for immediateloading when good primarystability is achieved withappropriate occlusal loading.The Wide (Ø6.0 ~ Ø6.4) implantscan be placed with a conventionaltwo stage surgical process with anoption fortransmucosal healing and areindicated for the molar regionwith delayed loading.
Design	Image: Two implants	-	Image: Two implants
Diameter	Ø4.0	-	Ø4.0, 4.5 and 5.5
GingivalHeight	1.8 and 3.8mm	-	1.5, 2.0, 3.0, 4.0 and 5.0 mm
Angled	15°	-	15° and 25°
Coating	TiN Coating	-	TiN Coating
Material	Ti-6Al-4V ELI	-	Ti-6Al-4V ELI
Sterilization	End User Sterilization	End User Sterilization	End User Sterilization
Comparison	The subject device and reference predicate, K182194 have same intended use, material, coatingand sterilization method. The differences between the two devices are dimensions andindications. The dimensions of the subject device are in range of the predicate device and theindications for use of the subject device is exactly same as the primary predicate, K161244;therefore, the subject device is substantial equivalent.

s-Clean TiN Half Coating Angled Abutment (Narrow)

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s-Clean Temporary Abutment (Narrow)

	Subject Device	Primary Predicate	Reference Device
K number	K230246	K161244	K210080
Manufacturer	Dentis Co., Ltd	Dentis Co., Ltd	Dentis Co., Ltd
Trade Name	Dentis s-Clean SQ-SL NarrowImplant System	s-Clean OneQ-SL NarrowImplant System	Dentis s-Clean s-LineMini
Indications forUse	The Dentis s-Clean SQ-SL NarrowImplant System may be used as anartificial root structure forsingle tooth replacement of mandibularcentral and lateral incisors andmaxillary lateral incisors.The implants may be restoredimmediately1) with a temporary prosthesis that isnot in functional occlusion,2) when splinted together as anartificial root structure for multipletooth replacement of mandibularincisors, or3) for denture stabilization usingmultiple implants in the anteriormandible and maxilla.The implants may be placed inimmediate function when good primarystability has been achieved and withappropriate occlusal loading.	The s-Clean OneQ-SL NarrowImplant System may be used as anartificial root structure forsingle tooth replacement ofmandibular central and lateral incisorsand maxillary lateral incisors.The implants may be restoredimmediately1) with a temporary prosthesis that isnot in functional occlusion,2) when splinted together as anartificial root structure for multipletooth replacement of mandibularincisors, or3) for denture stabilization usingmultiple implants in the anteriormandible and maxilla.The implants may be placed inimmediate function when goodprimary stability has been achievedand with appropriate occlusal loading.	Dentis s-Clean s-Line Miniis indicated for use inpartially or fullyedentulous mandibles andmaxillae, in support ofsingle or multiple unitrestorations including;cemented retained, screwretained, or overdenturerestorations, and terminalor intermediate abutmentsupport for fixedbridgework. This system isdedicated for one and twostage surgicalprocedures. This system isintended for delayedloading.
Design	Image: Subject Device Design	Image: Primary Predicate Design	Image: Reference Device Design
Diameter	$Ø4.0$	-	$Ø4.0$ , 4.5 and 5.5
Length	12.5, 13, 14.5 and 15 mm	-	13.45, 13.7, 15.45 and15.7mm
Coating	Non	-	Non
Material	PEEK	-	PEEK
Sterilization	End User Sterilization	-	End User Sterilization
Comparison	The subject device and reference device, K210080 have the same material and applications andsimilar dimensions. The differences between two devices are lengths and indications for use. Thelength difference is not important factor for performance because this device is used temporarily andthe indications for use of the subject device is exactly same as the primary predicate, K161244;therefore, the subject device is substantial equivalent.

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Non-Clinical Test Data

Below tests were performed on subject device:

Fatigue Testing 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 on Abutment according to ISO 10993-1:2009 referenced in K171694
. End User Sterilization Validation Test Report on Abutments according to ANSI/AAMI ST79, ISO 17665-1,-2, ISO 11737-1,-2, and ISO 11138-1 referenced in K171694 and K171027

The surface modification information with TiN Coating for Abutments was provided. To compare surface modification between the subject and predicate devices, K171694 and , chemical composition, SEM, EDS, adhesion and thickness were provided, and it demonstrate the substantial equivalence.

The end user sterilization test was performed for predicate device. K171694 and K171027 and leveraged for the subject device because the product category, material, manufacturing process, facility, and packaging of both products are exactly same.

The Biocompatibility Test was conducted on the predicate device and leveraged for the subject device because both products are manufactured with same materials and manufacturing process. It demonstrates that the subject device is biocompatible and substantial equivalence with the predicate.

The Fatigue Testing was performed under the worst-case scenario according to ISO 14801:2016.

MR Environment Condition

Non-clinical worst-case MRI review was performed to evaluate the metallic Dentis SQ-SL Implant System 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.

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

Conclusion

Dentis s-Clean SQ-SL Narrow Implant System 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, Dentis s-Clean SO-SL Narrow Implant System 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.)