Predicate Devices

Reference Devices

K123155, K123988, K150344, K161689, K171027, K171694, K192436, K200099, K202773, K111364, K192688

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties, materials, and mechanical testing of dental implants and abutments. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.

Therapeutic

Yes
This device is a dental implant system used to replace missing teeth, which is a therapeutic intervention.

Diagnostic

No

This device is described as an implant system for replacing missing teeth, which is a therapeutic rather than a diagnostic function.

SaMD (Software as a Medical Device)

No

The device description clearly states that the device is composed of physical components (Fixture and Abutments) made of materials like titanium and PEEK, which are implanted into the bone. This is a hardware medical device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, the Dentis s-Clean s-Line Mini is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use clearly states that the device is for supporting dental restorations in the mandible and maxillae. This involves surgical implantation and mechanical support within the body.
Device Description: The description details a dental implant system composed of fixtures and abutments made of materials like titanium and PEEK, designed to be placed in bone.
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.

IVD devices are used outside the body to analyze biological samples. The Dentis s-Clean s-Line Mini is an implantable medical device used within the body for structural support.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Dentis s-Clean s-Line Mini is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures. This system is intended for delayed loading.

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

DZE, NHA

Device Description

Dentis s-Clean s-Line Mini is composed of Fixture and Abutments. s-Clean SQ-SL Fixture Mini is a thread type implant made of Pure titanium according to ASTM F67 which will be placed in the alveolar bone to replace the function of the missing tooth. This device has connection between the upper prosthesis and the internal Hex.

The subject implant body has a two screw-joint (structured with Upper and Lower screw joints) and a hex anti-rotation design connection. The two-screw-joint feature is for diverse screw connection with other abutment that has 1.6M screw or 2.0M Screw. s-Clean Sole Abutment s-Line Mini and s-Clean TiN Half Coating Sole Abutment s-Line Mini have Upper M2.0 screw and s-Clean Couple Abutment s-Line Mini, s-Clean TiN Half Coating Couple Abutment s-Line Mini, s-Clean Angled Abutment s-Line Mini and s-Clean TiN Half Coating Angled Abutment s-Line Mini have Lower M1.6 screw. When dividing screw assemble design, screw assembled one-piece abutment is connected with upper screw and screw separated two-piece abutment is connected with lower screw.

The surface of fixture is treated with SLA (Sandblasted with Large-grit and Acid-etching). It is only part to be implanted into bone, and to provide connection of prosthetic devices or other components of a dental implant set with human body (mandibular or maxillary bone).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

mandibles and maxillae

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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 Test Data:

Fatigue Testing under the worst-case scenario according to ISO 14801:2016.
Sterilization Validation Test on Fixtures according to ISO 11137-1.2,3 referenced in K192688.
End User Sterilization Validation Test Report on Abutments according to ANSI/AAMI ST79. ISO 17665-1, ISO 17665-2, ISO 11737-1, ISO 11737-2, and ISO 11138-1 referenced in K11364.
Shelf-Life Test on Fixtures according to ASTM F1980 referenced in K153639.
Biocompatibility testing on fixtures according to ISO 10993-1:2009. ISO 10993-3:2014. ISO 10993-5:2009, ISO 10993-6:2007, ISO 10993-10:2010 and ISO 10993-11:2006 referenced in K153639.
Biocompatibility testing on Abutments made with Ti-6Al-4V ELI according to ISO 10993-1:2009, ISO 10993-3:2014, ISO 10993-5:2009, ISO 10993-6:2007, ISO 10993-10:2010 and ISO 10993-11:2006 referenced in K171027 and K150344.
Biocompatibility testing on TiN Coating Abutments according to ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-10:2010 and ISO 10993-11:2006 referenced in K171694.
Biocompatibility evaluation on abutments made with PEEK referenced in K171027.
Bacterial Endotoxin Test Report on Fixtures according to ANSI/AAMI ST72:2011, USP , and USP referenced in K192688.

Results: The results of the above tests have met the criteria of the standards, and demonstrated the substantial equivalence with the predicate device. The surface modification information with SLA for fixtures was provided, and to compare surface modification between the subject and predicate devices, K153639, surface roughness, surface composition analysis, and SEM imaging were provided, demonstrating substantial equivalence. The Sterilization validation test and shelf-life test for fixtures were performed for predicate device, K192688 and K153639 and leveraged for the subject device because the material, sterilization method, packaging methods, and manufacturing process of both products are exactly same. The end user sterilization test was performed for predicate device, K111364 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. The fatigue testing per ISO 14801 was conducted under the worst-case scenario. To demonstrate the substantial equivalence of the device performance between single screw joint implant and dual screw joint implant, two fatigue tests were performed comparatively, and results indicate substantial equivalence. The non-clinical testing results demonstrate that the subject device is substantially equivalent to the predicate device.

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.

K153639

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.

K123155, K123988, K150344, K161689, K171027, K171694, K192436, K200099, K202773
Reference device K111364 is mentioned in the non-clinical test data.
Reference device K192688 is mentioned in the non-clinical test data.

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

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.

Summary

0

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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

Re: K210080

Trade/Device Name: Dentis s-Clean s-Line Mini Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: May 3, 2021 Received: May 6, 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.

1

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

2

Indications for Use

510(k) Number (if known) K210080

Device Name Dentis s-Clean s-Line Mini

Indications for Use (Describe)

Dentis s-Clean s-Line Mini is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures. This system is intended for delayed loading.

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CER 801 Subpart D)	□ Over-The-Counter Use (21 CER 801 Subpart C)

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3

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: Dentis s-Clean s-Line Mini ●
Common Name: Dental Implant System
Classification Name: Endosseous dental implant ●
Product Code: DZE
Secondary Product Code: NHA ●
Panel: Dental
Regulation Number: 872.3640
Device Class: Class II
Date Prepared: 06/04/2021

Predicate Devices:

Primary Predicate

K153639, Dentis Dental Implant System manufactured by Dentis Co., Ltd. ●

Reference devices

K123155, Luna Dental Implant System manufactured by SHINHUNG MST Co., Ltd. ●
K123988. AnyOne Internal Implant System by MegaGen implant Co., Ltd
K150344, Dentis Dental Implant System manufactured by Dentis Co., Ltd.
K161689, OSSTEM Implant System - Abutment by OSSTEM Implant Co., Ltd
K171027, Dentis Dental Implant System manufactured by Dentis Co., Ltd. ●
K171694, s-Clean TiN Coating Abutment manufactured by Dentis Co., Ltd.
K192436, Healing Abutments and Cover Screws manufactured by Dentium Co., Ltd.
K200099, s-Clean SQ-SL Implant System Mini manufactured by Dentis Co., Ltd. ●
K202773. s-Clean SO-SL Implant System Mini manufactured by Dentis Co., Ltd. ●

Indication for Use:

Dentis s-Clean s-Line Mini is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures. This system is intended for delayed loading.

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

Official Correspondent

4

Device Description:

Dentis s-Clean s-Line Mini is composed of Fixture and Abutments. s-Clean SO-SL Fixture Mini is a thread type implant made of Pure titanium according to ASTM F67 which will be placed in the alveolar bone to replace the function of the missing tooth. This device has connection between the upper prosthesis and the internal Hex.

The subject implant body has a two screw-joint (structured with Upper and Lower screw joints) and a hex anti-rotation design connection. The two-screw-joint feature is for diverse screw connection with other abutment that has 1.6M screw or 2.0M Screw. s-Clean Sole Abutment s-Line Mini and s-Clean TiN Half Coating Sole Abutment s-Line Mini have Upper M2.0 screw and s-Clean Couple Abutment s-Line Mini, s-Clean TiN Half Coating Couple Abutment s-Line Mini, s-Clean Angled Abutment s-Line Mini and s-Clean TiN Half Coating Angled Abutment s-Line Mini have Lower M1.6 screw. When dividing screw assemble design, screw assembled one-piece abutment is connected with upper screw and screw separated two-piece abutment is connected with lower screw.

The surface of fixture is treated with SLA (Sandblasted with Large-grit and Acid-etching). It is only part to be implanted into bone, and to provide connection of prosthetic devices or other components of a dental implant set with human body (mandibular or maxillary bone).

No.	Device Name	Dimension Ranges
1	s-Clean SQ-SL Fixture Mini	Ø5.8, 6.8 and 7.8 (D) X 7.5, 9.5, 11.4 and 11.5mm

The dimensions of fixtures are as following:

Tolerance of dimension shall be within ± 1% range.

No.	Device Name	Dimension Ranges	Angulation
1	s-Clean Cover Screw Mini	Ø3.2 (D) x 5.0mm (L)	0°
2	s-Clean Healing Abutment s-Line
Mini	Ø4.3, 4.8 and 5.8 (D) X 7.61, 8.61, 9.61, 10.61, 11.61,
12.61 and 14.61mm (L)	0°
3	s-Clean Sole Abutment s-Line
Mini	Ø4.5 and 5.5 (D) X 11.01, 12.01, 12.51, 13.01, 13.51,
14.01, 14.51, 15.01, 15.51, 16.01 and 17.01mm (L)	0°
4	s-Clean TiN Half Coating Sole
Abutment s-Line Mini	Ø4.5 and 5.5 (D) X 11.01, 12.01, 12.51, 13.01, 13.51,
14.01, 14.51, 15.01, 15.51, 16.01 and 17.01mm (L)	0°
5	s-Clean Couple Abutment s-Line
Mini	Ø4.0, 4.5 and 5.5 (D) X 8.35, 8.6, 9.35, 9.6, 9.85, 10.1,
10.35, 10.6, 10.85, 11.1, 11.35, 11.6, 11.85, 12.1, 12.35,
12.6, 12.85, 13.1, 13.35, 13.6, 14.35 and 14.6mm (L)	0°
6	s-Clean TiN Half Coating Couple
Abutment s-Line Mini	Ø4.0, 4.5 and 5.5 (D) X 8.35, 8.6, 9.35, 9.6, 9.85, 10.1,
10.35, 10.6, 10.85, 11.1, 11.35, 11.6, 11.85, 12.1, 12.35,
12.6, 12.85, 13.1, 13.35, 13.6, 14.35 and 14.6mm (L)	0°
7	s-Clean Angled Abutment s-Line
Mini	Ø4.0, 4.5 and 5.5 (D) X 12.09, 12.34, 12.51, 12.76,
13.09, 13.34, 13.51 and 13.76mm (L)	15° and 25°
8	s-Clean TiN Half Coating Angled
Abutment s-Line Mini	Ø4.0, 4.5 and 5.5 (D) X 12.09, 12.34, 12.51, 12.76,
13.09, 13.34, 13.51 and 13.76mm (L)	15° and 25°
9	s-Clean Abutment Screw s-Line
Mini	Ø2.03 (D) X 10.2mm (L)	0°
10	s-Clean Temporary Abutment
Mini	Ø4.0, 4.5 and 5.5 (D) X 13.45, 13.7, 15.45 and 15.7mm	0°
11	s-Clean MU Straight Abutment
Mini	Ø4.8 (D) X 8.71, 9.71, 10.71, 11.71 and 12.71mm (L)	0°

The dimensions of abutments are as following:

5

| 12 | s-Clean MU Angled Abutment
Mini | Ø1.56 (D) X 7.25, 7.74, 8.25, 8.74, 9.25, 9.74, 10.25
and 10.74mm (L) | 17° and 30° |
|----|------------------------------------------|--------------------------------------------------------------------------|-------------|
| 13 | s-Clean MU Angled Abutment
Screw Mini | Ø1.56 (D) X 9.3mm (L) | 0° |

The Abutments have below featured:

Name	Uses	Surface	Connection
s-Clean Cover Screw Mini	It is used for protecting inner hole and
connecting part with exposed upper part
of structure during the healing period after
inserting dental implant fixture	Anodizing
(Gold Color)	Screw
Retained
s-Clean Healing Abutment
s-Line Mini	The healing Abutment is used for
protecting inner hole of fixture and
adjusting the appropriate height during the
healing period	Anodizing
(Gold Color)	Screw
Retained
s-Clean Sole Abutment s-Line Mini		N/A
s-Clean TiN Half Coating Sole
Abutment s-Line Mini	The Abutment is connected with fixture	TiN-Coating	Internal Hex
s-Clean Couple Abutment s-Line Mini	The Abutment is connected with fixture
and it supports prosthesis which restores
tooth function.	N/A
s-Clean TiN Half Coating Couple
Abutment s-Line Mini	The Abutment is connected with fixture	TiN-Coating	Internal Hex
s-Clean Angled Abutment s-Line
Mini	The Abutment is connected with fixture
and it supports prosthesis which restores
tooth function	N/A
s-Clean TiN Half Coating Angled
Abutment s-Line Mini		TiN-Coating	Internal Hex
s-Clean Abutment Screw s-Line Mini	This screw is used for connect fixture and
abutment	N/A	Screw
Retained
s-Clean Temporary Abutment Mini	This Abutment is used for prosthetic
restore temporary	N/A	Internal Hex
s-Clean MU Straight Abutment Mini	MU Abutment is useful for various	TiN-Coating	Internal Hex
s-Clean MU Angled Abutment Mini	angulation implanted fixture and gingival
angulation.	TiN-Coating	Internal Hex
s-Clean MU Angled Abutment Screw
Mini	This Screw is used for fixture and MU
Angled Abutment	N/A	Screw
Retained

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

The multi-unit abutments are only intended to be used in multi-unit restorations.

The purpose of Anodizing for s-Clean Cover Screw Mini and s-Clean Healing Abutment s-Line Mini is to distinguish the sizes with the naked eyes for convenience.

s-Clean SQ-SL Fixture Mini, s-Clean Cover Screw Mini and s-Clean Healing Abutment s-Line Mini are provided sterilized. And the other Abutments are provided non-sterilized.

s-Clean SO-SL Fixture Mini is enclosed with s-Clean Cover Screw Mini in a set packing. s-Clean Cover Screw Mini is also provided separately.

Materials:

s-Clean SQ-SL Fixture Mini, s-Clean Cover Screw Mini, s-Clean Healing Abutment s-Line Mini and ● s-Clean Temporary Abutment Mini are fabricated from Pure titanium of ASTM F67
The s-Clean (TiN Half Coating) Sole Abutment s-Line Mini, s-Clean (TiN Half Coating) Couple ● Abutment s-Line Mini, s-Clean (TiN Half Coating) Angled Abutment s-Line Mini, s-Clean Abutment Screw s-Line Mini, s-Clean MU Straight Abutment Mini, s-Clean MU Angled Abutment Mini and s-Clean MU Angled Abutment Screw Mini are fabricated from Ti-6Al-4V of ASTM F136
The s-Clean Temporary Abutment Mini is fabricated from PEEK material. ●

6

Summaries of Technological Characteristics & Substantial Equivalence Discussion

s-Clean SO-SL Fixture Mini
----------------------------	--

	Subject Device	Predicate Device	Reference Device
K number	NA	K153639	K202773
Manufacturer	Dentis Co., Ltd	Dentis Co., Ltd	Dentis Co., Ltd.
Trade Name	Dentis s-Clean s-Line
Mini	Dentis Dental Implant
System	s-Clean SQ-SL Implant System
Mini
Design	Image: Dentis s-Clean s-Line Mini	Image: Dentis Dental Implant System	Image: s-Clean SQ-SL Implant System Mini
Indications for
Use	Dentis s-Clean s-Line
Mini is indicated for use
in partially or fully
edentulous mandibles and
maxillae, in support of
single or multiple unit
restorations including;
cemented retained, screw
retained, or overdenture
restorations, and terminal
or intermediate abutment
support for fixed
bridgework. This system
is dedicated for one and
two stage surgical
procedures. This system is
intended for delayed
loading.	The OneQ-SL s-Clean
Implant System is
indicated for use in
partially or fully
edentulous mandibles and
maxillae, in support of
single or multiple unit
restorations including;
cemented retained, screw
retained, or overdenture
restorations, and terminal
or intermediate abutment
support for fixed
bridgework. This system is
dedicated for one and two
stage surgical procedures
and not dedicated for
immediate loading. This
system is intended for
delayed loading	s-Clean SQ-SL Implant System
Mini is indicated for use in
partially or fully edentulous
mandibles and maxillae, in
support of single or multiple unit
restorations including; cemented
retained, screw retained, or
overdenture restorations, and
terminal or intermediate
abutment support for fixed
bridgework. This system is
dedicated for one and two stage
surgical procedures.
This system is intended for
delayed loading.
Diameter	Ø5.8, 6.8 and 7.8	Ø3.7, 3.9, 4.2, 4.7, 5.2, 6.0,
7.0 and 8.0	Ø3.7, 4.1
Length	7.5, 9.5, 11.4, 11.5mm	7, 8, 10, 12, 14mm	7.5, 9.5, 11.5, 13.5mm
Surface
Treatment	SLA	SLA	SLA
Material	CP Titanium Gr4 (ASTM
F67)	CP Titanium Gr4 (ASTM
F67)	CP Titanium Grade4 (ASTM
F67)
Sterilization	Gamma Irradiation	Gamma Irradiation	Gamma Irradiation
Comparison	The Subject Device and primary predicate have same characteristics such as indications for
Use, design, diameter, length, surface treatment, material, abutment connection, and
sterilization.
The difference between subject and primary predicate is only design of screw joint between
fixture and abutment. Subject device has two screw-joint of fixture and abutment but primary
predicate has only one screw-joint of fixture and abutment. This difference is mitigated
through our own device, K202773. Any differences in technology characteristics are
accompanied by information that demonstrated the device is substantially equivalent as the
predicate and do not raise different questions of safety and effectiveness than the predicate.

7

s-Clean Cover Screw Mini

	Subject Device	Reference Device	Reference Device
K number	NA	K200099	K192436
Manufacturer	Dentis Co., Ltd	Dentis Co., Ltd	Dentium Co., Ltd
Trade Name	Dentis s-Clean s-Line Mini	s-Clean SQ-SL Implant System Mini	Healing Abutments and Cover Screws
Model	s-Clean Cover screw Mini	s-Clean Mini Fixture Cover screw	Cover screw
Design	Image: Subject Device Design	Image: Reference Device K200099 Design	Image: Reference Device K192436 Design
Diameter	$Ø$ 3.2	$Ø$ 3.1	$Ø$ 3.10, 3.18, 3.37, 3.50, 3.55, 4.12 and 4.30
Length	5.0mm	5.4mm	4.70, 5.40, 5.70, 5.75, 6.35, 6.36, 6.88 and 8.92mm
Coating	Anodizing (Gold Color)	Non	Anodizing (Black, Blue, Green Color) / Non
Material	Titanium Gr4 (ASTM F67)	Titanium Gr4 (ASTM F67)	Ti-6Al-4V ELI (ASTM F136)
Sterilization	Sterile	Sterile	Sterile
Comparison	Subject Device and Reference Device, K200099 have same indications and material. The diameter and length are different from K200099, but this difference is not important factor to the device performance. Subject device is anodized to make a division according to device size. To support the surface coating and dimension differences from K200099, K192436 is added as the reference device. Therefore, the subject device is substantial equivalent.

s-Clean Healing Abutment s-Line Mini

	Subject Device	Reference Device	Reference Device
K number	NA	K171027	K123155
Manufacturer	Dentis Co., Ltd	Dentis Co., Ltd	SHINHUNG MST CO.,
Ltd
Trade Name	Dentis s-Clean s-Line Mini	Dentis Dental Implant System	Luna Dental Implant
System
Model	s-Clean Healing Abutment s-
Line Mini	Healing Abutment	Healing Abutment
Design	Image: Subject Device Design	Image: Reference Device K171027 Design	Image: Reference Device K123155 Design
Diameter	Ø4.3, 4.8 and 5.8	Ø4.0, 4.5, 4.8, 5.0, 5.5, 6.0, 6.5,
7.0 and 7.5	Ø4.5~7.0
Length	7.61, 8.61, 9.61, 10.61, 11.61,
12.61 and 14.61mm	9.5, 10.0, 10.5, 11.0, 11.5, 12.0,
12.5, 13.0, 13.5 and 14.0mm	2.0, 3.5, 5.0 and 7.0
Coating	Anodizing (Gold Color)	Non	Anodizing
(Purple, Blue Color)
Material	Titanium Gr4 (ASTM F67)	Titanium Gr4 (ASTM F67)	Titanium Gr4 (ASTM F67)
Sterilization	Sterile	Sterile	Sterile
Comparison	Subject Device and reference device, K171027 have same Indications and material. The diameter
and length are different from K171027 but this difference is not important factor to the device
performance. Subject device is anodized to make a division according to device size. This
difference about surface coating is explained through Reference Device, K123155. Therefore, the
subject device is substantial equivalent.

8

	Subject Device	Reference Device	Reference Device
K number	NA	K171694	K171027
Manufacturer	Dentis Co., Ltd	Dentis Co., Ltd	Dentis Co., Ltd
Trade Name	Dentis s-Clean s-Line
Mini	s-Clean TiN Coating Abutment	Dentis Dental Implant
System
Model	s-Clean Sole
Abutment s-Line Mini
& s-Clean TiN Half
Coating Sole
Abutment s-Line Mini	s-Clean TiN Partial Coating Sole
Abutment	Sole Abutment
Design	Image: Design of subject device	Image: Design of reference device K171694	Image: Design of reference device K171027
Diameter	Ø4.5 and 5.5	Ø4.5, 4.8, 5.5, 6.0 and 6.5	Ø4.5, 4.8, 5.5, 6.0 and
6.5
Gingival Height	1.8, 2.8, 3.8, 4.8	0.8, 1.3, 1.8, 2.3, 3.3, 4.3 and 5.3	0.8, 1.3, 1.8, 2.3, 3.3,
4.3, and 5.3
Length	11.01, 12.01, 12.51,
13.01, 13.51, 14.01,
14.51, 15.01, 15.51,
16.01 and 17.01mm	10.6, 11.0, 11.5, 11.6, 12.0, 12.1,
12.5, 13.0, 13.1, 13.5, 13.6, 14.0,
14.1, 14.5, 15.0, 15.1, 15.5, 16.0,
16.1, 16.5, 16.6, 17.0, 17.1, 17.5,
18.1 and 18.5mm	12.5, 13.0, 13.5, 14.0,
15.0, 16.0 and 17.0mm
Coating	Non & TiN Coating	TiN Coating	Non
Material	Ti-6Al-4V ELI
(ASTM F136)	Ti-6Al-4V ELI
(ASTM F136)	Ti-6Al-4V ELI
(ASTM F136)
Sterilization	End User Sterilization	End User Sterilization	End User Sterilization
Comparison	Subject Device and Reference Devices, K171694 and K171027 have same diameter,
length, material and sterilization method. The subject device has two types of surface
coating, non-coating and TiN coating. K171027 is selected for non-coating abutment and
K171694 is selected for TiN coating abutment as predicates. The subject device is
substantial equivalent.

s-Clean Sole Abutment s-Line Mini & s-Clean TiN Half Coating Sole Abutment s-Line Mini

s-Clean Couple Abutment s-Line Mini & s-Clean TiN Half Coating Couple Abutment s-Line Mini

	Subject Device		Reference Device	Reference Device
K number	NA		K171694	K171027
Manufacturer	Dentis Co., Ltd		Dentis Co., Ltd	Dentis Co., Ltd
Trade Name	Dentis s-Clean s-Line Mini		s-Clean TiN Coating
Abutment		Dentis Dental Implant System
Model	s-Clean Couple Abutment
s-Line Mini & s-Clean TiN
Half Coating Couple
Abutment s-Line Mini		s-Clean TiN Half Coating
Couple Abutment		Couple Abutment
Design	Image: Subject Device Design		Image: Reference Device K171694 Design	Image: Reference Device K171027 Design
Diameter	Ø4.0, 4.5 and 5.5		Ø4.5, 4.8, 5.5, 6.0 and Ø6.5	Ø4.0, 4.5, 4.8, 5.5, 6.0 and Ø6.5
Gingival Height	1.8, 2.8, 3.8, 4.8		0.8, 1.3, 1.8, 2.3, 3.3, 4.3
and 5.3mm		0.8, 1.3, 1.8, 2.3, 3.3, 4.3 and
5.3mm
Length	8.35, 8.6, 9.35, 9.6, 9.85,
10.1, 10.35, 10.6, 10.85,
11.1, 11.35, 11.6, 11.85,
12.1, 12.35, 12.6, 12.85,		7.3, 7.44, 7.8, 7.94, 8.3,
8.44, 8.8, 8.94, 9.3, 9.44,
9.8, 9.94, 10.3, 10.44, 10.8,
10.94, 11.3, 11.44, 11.8,		7.3, 7.44, 7.8, 7.94, 8.3, 8.44,
8.8, 8.94, 9.3, 9.44, 9.8, 9.94,
10.3, 10.4, 10.44, 10.8, 10.9,
10.94, 11.3, 11.4, 11.44, 11.8,

9

| | 13.1, 13.35, 13.6, 14.35,
14.6 | 11.94, 12.3, 12.44, 12.8,
12.94, 13.3, 13.44, 13.8,
13.94, 14.8 and 14.94mm | 11.9, 11.94, 12.3, 12.44, 12.8,
12.9, 12.94, 13.3, 13.44, 13.8,
13.9, 13.94, 14.8, 14.9 and
14.94mm |
|---------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| Coating | Non | TiN Coating | Non |
| Material | Ti-6Al-4V ELI
(ASTM F136) | Ti-6Al-4V ELI
(ASTM F136) | Ti-6Al-4V ELI
(ASTM F136) |
| Sterilization | End User Sterilization | End User Sterilization | End User Sterilization |
| Comparison | Subject Device and Reference Devices, K171694 and K171027 have same diameter, length,
material and sterilization method. The subject device has two types of surface coating, non-
coating and TiN coating. K171027 is selected for non-coating abutment and K171694 is
selected for TiN coating abutment as predicates. The subject device is substantial equivalent. | | |

s-Clean Angled Abutment s-Line Mini & s-Clean TiN Half Coating Angled Abutment s-Line Mini

	Subject Device	Reference Device	Reference Device
K number	NA	K171694	K123988
Manufacturer	Dentis Co., Ltd	Dentis Co., Ltd	MegaGemImpalnt Co., Ltd
Trade Name	Dentis s-Clean s-Line Mini	s-Clean TiN Coating Abutment	AnuOne Imternal Implant System
Model	s-Clean Angled Abutment s-Line Mini & s-Clean TiN Half Coating Angled Abutment s-Line Mini	s-Clean TiN Half Coating Angled Abutment	Angld Abutment
Design	Image: s-Clean Angled Abutment s-Line Mini & s-Clean TiN Half Coating Angled Abutment s-Line Mini	Image: s-Clean TiN Half Coating Angled Abutment	Image: Angld Abutment
Diameter	Ø4.0, 4.5 and 5.5	Ø4.5, 5.0,5.5 and Ø6.5	Ø3.8~10.0
Gingival
Height	2.8 and 3.8	0.8, 1.8 and 3.8mm	2.5 and 4.5mm
Length	12.09, 12.34, 12.51, 12.76, 13.09,
13.34, 13.51, 13.76,	10.18, 10.4, 10.46, 10.6,
11.18, 11.6, 12.4, 13.18 and
13.6	7.7~18.7
Angulation	15° and 25°	15° and 25°	15° and 25°
Coating	Non	TiN Coating	TiN Coating
Material	Ti-6Al-4V ELI
(ASTM F136)	Ti-6Al-4V ELI
(ASTM F136)	Ti-6Al-4V ELI
(ASTM F136)
Sterilization	End User Sterilization	End User Sterilization	End User Sterilization
Comparison	Subject Device and Reference Devices, K171694 and K171027 have same diameter, length,
material, angulation and sterilization method. The subject device has two types of surface
coating, non-coating and TiN coating. K171027 is selected for non-coating abutment and
K171694 is selected for TiN coating abutment as predicates. The subject device is substantial
equivalent.

10

s-Clean Abutment Screw s-Line Mini

	Subject Device	Reference Device
K number	NA	K171027
Manufacturer	Dentis Co., Ltd	Dentis Co., Ltd
Trade Name	Dentis s-Clean s-Line Mini	s-Clean TiN Coating Abutment
Model	s-Clean Abutment Screw s-Line Mini	Abutment Screw
Design	Image: Subject Device Design	Image: Reference Device Design
Head Diameter	$Ø$ 2.03	$Ø$ 2.32
Length	10.2mm	8.8, 9.8, 9.95 and 10.5mm
Coating	Non	Non
Material	Ti-6Al-4V ELI (ASTM F136)	Ti-6Al-4V ELI (ASTM F136)
Sterilization	End User Sterilization	End User Sterilization
Comparison	Subject Device and Reference Device, K171694 have same material and applications and
similar dimensions. The diameter is different but this difference is not important factor to
the device performance. Therefore, the subject device is substantial equivalent.

s-Clean Temporary Abutment Mini

	Subject Device	Reference Device	Reference Device
K number	NA	K171027	K161689
Manufacturer	Dentis Co., Ltd	Dentis Co., Ltd	OSSTEM Implant Co., Ltd
Trade Name	Dentis s-Clean s-Line Mini	Dentis Dental Implant System	OSSTEM Implant System - Abutment
Model	s-Clean Temporary Abutment Mini	Temporary Abutment	Quick Temporary Abutment
Design	Image: Design of s-Clean Temporary Abutment Mini	Image: Design of Temporary Abutment	Image: Design of Quick Temporary Abutment
Diameter	$Ø$ 4.0, 4.5, and 5.5	$Ø$ 4.5, 4.8, 5.5, 6.0 and 6.5	$Ø$ 4.0 and 4.5
Length	13.45, 13.7, 15.45 and 15.7mm	13.4 and 13.54mm	11.5mm
Coating	Non	Non	Non
Material	PEEK	PEEK	PEEK
Sterilization	End User Sterilization	End User Sterilization	End User Sterilization
Comparison	Subject Device and Reference Device, K171027 have same material and applications and similar dimensions. Difference are lengths but this difference is not important factor for performance because this device is used for temporary and explained through Reference Device, K161689

11

s-Clean Temporary Abutment Mini

	Subject Device	Reference Device	Reference Device
K number	NA	K171027	K161689
Manufacturer	Dentis Co., Ltd	Dentis Co., Ltd	OSSTEM Implant Co., Ltd
Trade Name	Dentis s-Clean s-Line Mini	Dentis Dental Implant
System	OSSTEM Implant System -
Abutment
Model	s-Clean Temporary
Abutment Mini	Temporary Abutment	Quick Temporary Abutment
Design	Image: Design of s-Clean Temporary Abutment Mini	Image: Design of Temporary Abutment	Image: Design of Quick Temporary Abutment
Diameter	⌀4.0, 4.5, and 5.5	⌀4.5, 4.8, 5.5, 6.0 and 6.5	⌀4.0 and 4.5
Length	13.45, 13.7, 15.45 and
15.7mm	13.4 and 13.54mm	13.0, 13.5, 13.6, 15.0, 15.5
and 15.6mm
Coating	Non	Non	Non
Material	CP Titanium Gr4
(ASTM F67)	CP Titanium Gr4
(ASTM F67)	Ti-6Al-4V ELI
(ASTM F136)
Sterilization	End User Sterilization	End User Sterilization	End User Sterilization
Comparison	Subject Device and Reference Device, K171027 have same material and applications and
similar dimensions. Difference are diameter but this difference is not important factor for
performance because this device is used for temporary and explained through Reference
Device. K161689.

s-Clean MU Straight Abutment Mini

	Subject Device	Reference Device	Reference Device
K number	NA	K150344	K171694
Manufacturer	Dentis Co., Ltd	Dentis Co., Ltd	Dentis Co., Ltd
Trade Name	Dentis s-Clean s-Line
Mini	Dentis Dental Implant
System	s-Clean TiN Coating Abutment
Model	s-Clean MU Straight
Abutment Mini	MU Solid Abutment	s-Clean TiN Partial Coating Sole
Abutment
Design	Image: s-Clean MU Straight Abutment Mini	Image: MU Solid Abutment	Image: s-Clean TiN Partial Coating Sole Abutment
Diameter	$Ø4.8$	$Ø4.8$	$Ø4.5$ , 4.8, 5.5, 6.0 and 6.5
Length	8.71, 9.71, 10.71, 11.71
and 12.71mm	4.34, 5.34, 6.08, 6.34, 6.69,
7.34, 8.08, 8.69, 9.2, 10.2,
11.2 and 12.2mm	10.6, 11.0, 11.5, 11.6, 12.0, 12.1,
12.5, 13.0, 13.1, 13.5, 13.6, 14.0,
14.1, 14.5, 15.0, 15.1, 15.5, 16.0,
16.1, 16.5, 16.6, 17.0, 17.1, 17.5,
18.1 and 18.5mm
Coating	TiN Coating	Non	TiN Coating
Material	Ti-6Al-4V ELI
(ASTM F136)	Ti-6Al-4V ELI
(ASTM F136)	Ti-6Al-4V ELI
(ASTM F136)
Sterilization	End User Sterilization	End User Sterilization	End User Sterilization
Comparison	Subject Device and Reference Device, K150344 have same material, diameter and
applications. Differences between subject device and reference device is surface coating and
lengths. To support this discrepancy, K171694 is added. The length difference doesn't affect
product performance because the subject device's lengths are in range of the predicate's.
Therefore, the subject device is substantial equivalent.

12

	Subject Device	Reference Device	Reference Device
K number	NA	K150344	K171694
Manufacturer	Dentis Co., Ltd	Dentis Co., Ltd	Dentis Co., Ltd
Trade Name	Dentis s-Clean s-Line
Mini	Dentis Dental Implant
System
Multi-unit Abutments	s-Clean TiN Coating Abutment
Model	s-Clean MU Angled
Abutment Mini	MU Angled Abutment	s-Clean TiN Half Coating Angled
Abutment
Design	Image: s-Clean MU Angled Abutment Mini	Image: MU Angled Abutment	Image: s-Clean TiN Half Coating Angled Abutment
Diameter	Ø4.8	Ø4.8	Ø4.5, 5.0,5.5 and Ø 6.5
Length	7.25, 7.74, 8.25, 8.74,
9.25, 9.74, 10.25 and
10.74mm	4.34, 5.34, 6.08, 6.34, 6.69,
7.34, 8.08, 8.69, 9.2, 10.2,
11.2 and 12.2mm	10.18, 10.4, 10.46, 10.6, 11.18,
11.6, 12.4, 13.18 and 13.6
Angulation	17° and 30 °	17° and 30 °	15° and 25°
Coating	TiN Coating	Non	TiN Coating
Material	Ti-6Al-4V ELI
(ASTM F136)	Ti-6Al-4V ELI
(ASTM F136)	Ti-6Al-4V ELI
(ASTM F136)
Sterilization	End User Sterilization	End User Sterilization	End User Sterilization
Comparison	Subject Device and Reference Device, K150344 have same indications, material, diameter,
angulation, and sterilization method. Differences between subject device and reference device
is surface coating and lengths. To support this discrepancy, K171694 is added. The length
difference doesn't affect product performance because the subject device's lengths are in range
of the predicate's. Therefore, the subject device is substantial equivalent.

s-Clean MU Angled Abutment Mini

s-Clean MU Angled Abutment Screw Mini

	Subject Device	Reference Device
K number	NA	K150344
Manufacturer	Dentis Co., Ltd	Dentis Co., Ltd
Trade Name	Dentis s-Clean s-Line Mini	Dentis Dental Implant System
Model	s-Clean MU Angled Abutment Screw Mini	MU Abutment Screw
Design	Image: Subject Device Design	Image: Reference Device Design 1, Image: Reference Device Design 2
Head Diameter	$Ø$ 1.56	$Ø$ 1.96 and 2.32
Length	9.3	7.8, 9.2, 10.2, 11.2 and 12.2mm
Material	Ti-6Al-4V ELI (ASTM F136)	Ti-6Al-4V ELI (ASTM F136)
Sterilization	End User Sterilization	End User Sterilization
Comparison	Subject Device and Reference Device, K150344 have same indications and material and similar dimensions. The diameter and length is different but this difference is not important factor to the device performance. Therefore, the subject device is substantial equivalent.

13

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:
Sterilization Validation Test on Fixtures according to ISO 11137-1.2,3 referenced in K192688 ●
End User Sterilization Validation Test Reort on Abutments according to ANSVAAMI ST79. ● ISO 17665-1, ISO 17665-2, ISO 11737-1, ISO 11737-2, and ISO 11138-1 referenced in K11364
Shelf-Life Test on Fixtures according to ASTM F1980 referenced in K153639
Biocompatibility testing on fixtures according to ISO 10993-1:2009. ISO 10993-3:2014. ISO ● 10993-5:2009, ISO 10993-6:2007, ISO 10993-10:2010 and ISO 10993-11:2006 referenced in K153639
. Biocompatibility testing on Abutments made with Ti-6Al-4V ELI according to ISO 10993-1:2009, ISO 10993-3:2014, ISO 10993-5:2009, ISO 10993-6:2007, ISO 10993-10:2010 and ISO 10993-11:2006 referenced in K171027 and K150344
Biocompatibility testing on TiN Coating Abutments according to ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-10:2010 and ISO 10993-11:2006 referenced in K171694
Biocompatibility evaluation on abutments made with PEEK referenced in K171027
Bacterial Endotoxin Test Report on Fixtures according to ANSVAAMI ST72:2011, USP , and USP referenced in K192688

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

The surface modification information with SLA (Sandblasted with Large-grit and Acid-etching) for fixtures was provided. To compare surface modification between the subject and predicate devices, K153639, surface roughness, surface composition analysis, and SEM imaging were provided and it demonstrate the substantial equivalence.

The Sterilization validation test and shelf-life test for fixtures were performed for predicate device, K192688 and K153639 and leveraged for the subject device the material, sterilization method, packaging methods, and manufacturing process of the both products are exactly same.

The end user sterilization test was performed for predicate device, K111364 and leveraged for the subject device because the product category, material, manufacturing process, facility, and packaging of the 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.

The fatigue testing per ISO 14801 was conducted under the worst-case scenario. To demonstrate the substantial equivalence of the device performance between single screw joint implant and dual screw joint implant, two fatigue tests were performed comparatively, and result say that device performance was substantial equivalent.

The non-clinical testing results demonstrate that the subject device is substantially equivalent to the predicate device.

Conclusion

Dentis s-Clean s-Line 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, Dentis s-Clean s-Line Mini and its predicates are substantially equivalent.