Dentis s-Clean s-Line
Device Facts
| Record ID | K210134 |
|---|---|
| Device Name | Dentis s-Clean s-Line |
| Applicant | Dentis Co., Ltd. |
| Product Code | DZE · Dental |
| Decision Date | Apr 19, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3640 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
Dentis s-Clean s-Line 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.
Device Story
Dentis s-Clean s-Line is an endosseous dental implant system comprising fixtures and various abutments. Fixtures are placed into the alveolar bone to replace missing teeth; abutments connect to fixtures to support dental prostheses. The system is used in dental clinics by dentists for one or two-stage surgical procedures. Fixtures feature an internal hex connection and SLA (sandblasted, large-grit, acid-etched) surface treatment. Abutments include healing, sole, couple, angled, and multi-unit (MU) variants, some with TiN (Titanium Nitride) coating to potentially improve surface characteristics. The device provides a foundation for restorative dentistry, enabling the attachment of crowns, bridges, or overdentures. Clinical benefit includes restoration of tooth function and aesthetics for edentulous patients. Healthcare providers use the system to plan and execute implant-supported restorations based on patient anatomy.
Clinical Evidence
No clinical data provided. Substantial equivalence is supported by bench testing, including dynamic fatigue and static strength testing per ISO 14801:2016 and FDA guidance for root-form endosseous dental implants. Biocompatibility was assessed per ISO 10993-1. Sterilization validation was performed per ISO 11137-1/2, and shelf-life validation per ASTM F1980. Surface characteristics (SLA and TiN coating) were leveraged from predicate/reference devices (K153639, K171694) via chemical and microscopic analysis.
Technological Characteristics
Materials: Commercially Pure Titanium Grade 4 (ASTM F67), Ti-6Al-4V ELI (ASTM F136), and Chrome-cobalt-molybdenum alloy (ASTM F1537). Surface: SLA (Sandblasted with Large-grit and Acid-etching) for fixtures; TiN (Titanium Nitride) coating for specific abutments. Connection: Internal Hex. Sterilization: Gamma radiation (sterile) or end-user steam sterilization. Dimensions: Fixture diameters 5.8-7.8mm; various abutment lengths/diameters. Connectivity: Mechanical interface only.
Indications for Use
Indicated for partially or fully edentulous mandibles and maxillae in patients requiring single or multiple unit restorations (cemented, screw-retained, or overdenture) or terminal/intermediate abutment support for fixed bridgework. Dedicated for one or two-stage surgical procedures with delayed loading.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- OneQ SL s-Clean Implant System (K153639)
Reference Devices
- Dentis Dental Implant System (K082843)
- Dentis Dental Implant System (K150344)
- Dentis Dental Implant System (K171027)
- s-Clean TiN Coating Abutment (K171694)
- s-Clean SQ-SL Implant System Regular (K192688)
Related Devices
- K192688 — s-Clean SQ-SL Implant System Regular · Dentis Co., Ltd. · Feb 4, 2020
- K200099 — s-Clean SQ-SL Implant System Mini · Dentis Co., Ltd. · Apr 13, 2020
- K210080 — Dentis s-Clean s-Line Mini · Dentis Co., Ltd. · Jun 4, 2021
- K231426 — 8plant Implant System · Hoowon Edi Co., Ltd. · May 24, 2024
- K211090 — ZENEX Implant System · Izenimplant Co., Ltd. · Apr 13, 2022
Submission Summary (Full Text)
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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: K210134
Trade/Device Name: Dentis s-Clean s-Line Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: January 8, 2021 Received: January 19, 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 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) K210134
Device Name Dentis s-Clean s-Line
Indications for Use (Describe)
Dentis s-Clean s-Line 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 internediate 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)
> 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: Dentis s-Clean s-Line
- Common Name: Dental Implant System .
- Classification Name: implant, endosseous, root-. form
- . Product Code: DZE
- . Secondary Product Code: NHA
- . Panel: Dental
- . Regulation Number: 872.3640
- . Device Class: Class II
- Date Prepared: 04/19/2021 .
#### Predicate Devices:
The subject device is substantially equivalent to the following predicate devices:
#### Primary Predicate
- . K153639, OneQ SL s-Clean Implant System manufactured by Dentis Co., Ltd.
Reference devices
- K082843, Dentis Dental Implant System manufactured by Dentis Co., Ltd .
- . K150344, Dentis Dental Implant System manufactured by Dentis Co., Ltd.
- K171027, Dentis Dental Implant System manufactured by Dentis Co., Ltd. .
- . K171694, s-Clean TiN Coating Abutment manufactured by Dentis Co., Ltd.
- . K192688, s-Clean SQ-SL Implant System Regular
#### Indication for Use:
Dentis s-Clean s-Line 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.
#### 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:
Dentis s-Clean s-Line is composed of Fixture and Abutments. s-Clean SQ-SL Fixture 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 surface of fixture is treated with SLA (Sandblasted with Large-grit and Acidetching).
The dimensions of fixtures are as follows:
| No. | Device Name | Dimension Ranges |
|-----|-----------------------|-------------------------------------------------------------------------------|
| 1 | s-Clean SQ-SL Fixture | $ \varnothing $ 5.8, 6.8 and 7.8 (D) x 7.0, 7.5, 9.5, 11.4 and 11.5mm (L) |
Tolerance of dimension shall be within ± 1% range.
| No. | Device Name | Dimension Ranges | Angulation |
|-----|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| 1 | s-Clean Healing Abutment s-<br>Line | Ø4.8, 5.8, 6.8 and 7.8 (D) x 8.2, 9.2, 10.2, 11.2, 12.2, 13.2<br>and 15.2mm (L) | 0° |
| 2 | s-Clean Sole Abutment s-<br>Line | Ø4.5, 5.5 and 6.5 (D) x 13.1, 14.1, 14.6, 15.1, 15.6, 16.1,<br>16.6 and 17.6mm (L) | 0° |
| 3 | s-Clean TiN Half Coating<br>Sole Abutment s-Line | Ø4.5, 5.5 and 6.5 (D) x 13.1, 14.1, 14.6, 15.1, 15.6, 16.1,<br>16.6 and 17.6mm (L) | 0° |
| 4 | s-Clean Couple Abutment s-<br>Line | Ø4.5, 5.5 and 6.5 (D) x 8.3, 8.44, 9.3, 9.44, 9.8, 9.94, 10.3,<br>10.44, 10.8, 10.94, 11.3, 11.44, 11.8, 11.94, 12.3, 12.44,<br>12.8, 12.94, 13.3 13.44, 14.3 and 14.44mm (L) | 0° |
| 5 | s-Clean TiN Half Coating<br>Couple Abutment s-Line | Ø4.5, 5.5 and 6.5 (D) x 8.3, 8.44, 9.3, 9.44, 9.8, 9.94, 10.3,<br>10.44, 10.8, 10.94, 11.3, 11.44, 11.8, 11.94, 12.3, 12.44,<br>12.8, 12.94, 13.3 13.44, 14.3 and 14.44mm (L) | 0° |
| 6 | s-Clean Angled Abutment s-<br>Line | Ø4.5, 5.5 and 6.5 (D) x 12.04, 12.18, 12.46, 12.6, 13.04,<br>13.18, 13.46 and 13.6mm (L) | 15°, 25° |
| 7 | s-Clean TiN Half Coating<br>Angled Abutment s-Line | Ø4.5, 5.5 and 6.5 (D) x 12.04, 12.18, 12.46, 12.6, 13.04,<br>13.18, 13.46 and 13.6mm (L) | 15°, 25° |
| 8 | s-Clean Abutment Screw s-<br>Line | Ø2.32 (D) x 9.4mm (L) | 0° |
| 9 | s-Clean MU Straight<br>Abutment | Ø4.8 (D) x 9.3, 10.3, 11.3, 12.3 and 13.3mm (L) | 0° |
| 10 | s-Clean MU Angled<br>Abutment | Ø4.8 (D) x 7.09, 7.58, 8.09, 8.58, 9.09, 9.58, 10.09 and<br>10.58mm (L) | 17°, 30° |
| 11 | s-Clean MU Angled<br>Abutment Screw | Ø1.96 (D) x 8.08mm (L) | 0° |
| 12 | s-Clean MU Cylinder Screw | Ø1.97 (D) x 3.8mm (L) | 0° |
| 13 | s-Clean MU Healing Cap | Ø4.8 (D) x 4.1mm (L) | 0° |
| 14 | s-Clean MU Temporary<br>Cylinder | Ø4.8 (D) x 12mm (L) | 0° |
| 15 | s-Clean MU CCM Cylinder | Ø4.9 (D) x 14mm (L) | 0° |
The dimensions of abutments are as following:
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The Abutments have below featured:
| Name | Uses | Surface | Connection |
|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|-------------|---------------------|
| s-Clean Healing Abutment s-Line | The healing Abutment is used for protecting inner hole of fixture and adjusting the appropriate height during the healing period | Non | |
| s-Clean Sole Abutment s-Line | | Non | |
| s-Clean TiN Half Coating Sole<br>Abutment s-Line | | TiN-Coating | |
| s-Clean Couple Abutment s-Line | The Abutment is connected with fixture and it supports prosthesis which restores tooth function. | Non | |
| s-Clean TiN Half Coating Couple<br>Abutment s-Line | | TiN-Coating | |
| s-Clean Angled Abutment s-Line | | Non | |
| s-Clean TiN Half Coating Angled<br>Abutment s-Line | | TiN-Coating | |
| s-Clean Abutment Screw s-Line | This screw is used for connect fixture and abutment | Non | Internal Hex<br>2.5 |
| s-Clean MU Straight Abutment | MU Abutment is useful for various angulation implanted fixture and gingival angulation. | TiN-Coating | |
| s-Clean MU Angled Abutment | | TiN-Coating | |
| s-Clean MU Angled Abutment Screw | This Screw is used for fixture and MU Angled Abutment | Non | |
| s-Clean MU Cylinder Screw | This Screw is used for cylinder and MU Abutment | Non | |
| s-Clean MU Healing Cap | This Healing cap is used for protect the abutment and reduce patient discomfort. | Non | |
| s-Clean MU Temporary Cylinder | This Cylinder is used for fabricating provisional restoration | Non | |
| s-Clean MU CCM Cylinder | This Cylinder used for screw retained prostheses | Non | |
Tolerance of dimension for Abutments shall be within ± 1% range.
s-Clean SQ-SL Implant Fixture and s-Clean Healing Abutment s-Line are provided sterilized. And all other Abutments are provided non-sterilized.
### Materials:
- The fixtures, s-Clean Healing Abutment s-Line, and s-Clean MU Temporary Cylinder are fabricated ● from Commercially Pure Titanium Grade 4 (ASTM F67).
- . s-Clean Sole Abutment s-Line, s-Clean TiN Half Coating Sole Abutment s-Line, s-Clean Couple Abutment s-Line, s-Clean TiN Half Coating Couple Abutment s-Line, s-Clean Angled Abutment s-Line, s-Clean TiN Half Coating Angled Abutment s-Line, s-Clean Abutment Screw s-Line, s-Clean MU Straight Abutment, s-Clean MU Angled Abutment, s-Clean MU Angled Abutment Screw, s-Clean MU Cylinder Screw, and s-Clean MU Healing Cap are fabricated from Ti-6A1-4V (ASTM F136).
- The s-Clean MU CCM Cylinder is fabricated from Chrome-cobalt-molybdenum (CCM) alloy . material (ASTM F1537).
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# Summaries of Technological Characteristics & Substantial Equivalence Discussion
# s-Clean SQ-SL Fixture
| K number | Subject Device | Predicate Device |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Dentis Co., Ltd | Dentis Co., Ltd |
| Trade Name | Dentis s-Clean s-Line | OneQ SL s-Clean Implant System |
| Design | Image: Dentis s-Clean s-Line design | Image: OneQ SL s-Clean Implant System design |
| Indications for Use | Dentis s-Clean s-Line is indicated for use<br>in partially or fully edentulous mandibles<br>and maxillae, in support of single or<br>multiple unit restorations including;<br>cemented retained, screw retained, or<br>overdenture restorations, and terminal or<br>intermediate abutment support for fixed<br>bridework. This system is dedicated for<br>one and two stage surgical procedures.<br>This system is intended for delayed<br>loading. | The OneQ-SL s-Clean Implant System is<br>indicated for use in partially or fully<br>edentulous mandibles and maxillae, in<br>support of single or multiple unit<br>restorations including; cemented retained,<br>screw retained, or overdenture<br>restorations, and terminal or intermediate<br>abutment support for fixed<br>bridework. This system is dedicated for<br>one and two stage surgical procedures.<br>This system is intended for delayed<br>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 |
| Length | 7.0, 7.5, 9.5, 11.4 and 11.5mm | 7, 8, 10, 12 and 14mm |
| Surface Treatment | SLA | SLA |
| Material | CP Titanium Gr4 (ASTM F67) | CP Titanium Gr4 (ASTM F67) |
| Sterilization | Gamma sterile | Gamma sterile |
| Comparison | The Subject Device and Predicate Device (K153639) has same characteristics such as<br>Indications for Use, surface treatment, material, abutment connection, and sterilization. The<br>difference between two devices is the dimensions and external thread design. The difference<br>in dimensions is due to the change in external thread design. Since the dimensions of the<br>subject device are in range of the dimensions of the predicate, it doesn't impact device<br>performance. Therefore, subject device and predicate device are substantially equivalent. | |
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| | Subject Device | Reference Device |
|---------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|
| K number | NA | K171027 |
| Manufacturer | Dentis Co., Ltd | Dentis Co., Ltd |
| Trade Name | Dentis s-Clean s-Line | Dentis Dental Implant System |
| Model Name | s-Clean Healing Abutment s-Line | s-Clean Healing Abutment |
| Design | Image: Subject Device Design | Image: Reference Device Designs |
| Diameter | Ø4.8, 5.8, 6.8 and 7.8 | Ø4.0, 4.5, 4.8, 5.0, 5.5, 6.0, 6.5, 7.0 and 7.5 |
| Length | 8.2, 9.2, 10.2, 11.2, 12.2, 13.2 and 15.2mm | 9.5, 10.0, 10.5, 11.0, 11.5, 12.0, 12.5, 13.0, 13.5 and 14.0mm |
| Coating | Non | Non |
| Material | Titanium Gr4 (ASTM F67) | Titanium Gr4 (ASTM F67) |
| Sterilization | Sterile | Sterile |
| Comparison | Subject Device and Reference Device, K171027 have same indication for use and material. The diameter and length are different but this difference is not important factor to the device performance. Therefore, subject device and predicate device are substantially equivalent. | |
# s-Clean Healing Abutment s-Line
### s-Clean Sole Abutment s-Line & s-Clean TiN Half Coating Sole Abutment s-Line
| | 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 | s-Clean TiN Coating Abutment | Dentis Dental Implant System | |
| Model name | s-Clean Sole Abutment s-<br>Line / s-Clean TiN Half<br>Coating Sole Abutment s-<br>Line | s-Clean TiN Partial Coating<br>Sole Abutment | s-Clean Sole Abutment | |
| Design | Image: Design of Subject Device | Image: Design of Reference Device K171694 | Image: Design of Reference Device K171027 | |
| Diameter | Ø4.5, 5.5 and 6.5 | Ø4.5, 4.8, 5.5, 6.0 and 6.5 | Ø4.5, 4.8, 5.5, 6.0 and 6.5 | |
| Gingival<br>Height | 1.8, 2.8, 3.8 and 4.8mm | 0.8, 1.3, 1.8, 2.3, 3.3, 4.3 and<br>5.3mm | 0.8, 1.3, 1.8, 2.3, 3.3, 4.3, and<br>5.3mm | |
| Length | 13.1, 14.1, 14.6, 15.1, 15.6,<br>16.1, 16.6 and 17.6mm | 10.6, 11.0, 11.5, 11.6, 12.0,<br>12.1, 12.5, 13.0, 13.1, 13.5,<br>13.6, 14.0, 14.1, 14.5, 15.0,<br>15.1, 15.5, 16.0, 16.1, 16.5,<br>16.6, 17.0, 17.1, 17.5, 18.1 and<br>18.5mm | 12.5, 13.0, 13.5, 14.0, 15.0, 16.0<br>and 17.0mm | |
| Coating | Non/Tin Coating | TiN Coating | Non | |
| Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI | |
| | (ASTM F136) | (ASTM F136) | (ASTM F136) | |
| Sterilization | End User Sterilization | End User Sterilization | End User Sterilization | |
| Comparison | Subject Device and Reference Devices, K171694 and K171027 have same indications<br>sterilization and material, and similar dimensions. The subject device has two types of surface<br>coating, non-coating and TiN coating. K171027 is selected for non-coating abutment and<br>K171694 is selected for TiN coating abutment as predicates. The subject device is substantial<br>equivalent. | | | |
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| | 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 | s-Clean TiN Coating<br>Abutment | Dentis Dental Implant<br>System |
| Model Name | s-Clean Couple Abutment<br>s-Line / s-Clean TiN Half<br>Coating Couple<br>Abutment s-Line | s-Clean TiN Half Coating<br>Couple Abutment | s-Clean Couple Abutment |
| Design | Image: Design of s-Clean Couple Abutment s-Line / s-Clean TiN Half Coating Couple Abutment s-Line | Image: Design of s-Clean TiN Half Coating Couple Abutment | Image: Design of s-Clean Couple Abutment |
| Diameter | Ø4.5, 5.5 and 6.5 | Ø4.5, 4.8, 5.5, 6.0 and Ø6.5 | Ø4.0, 4.5, 4.8, 5.5, 6.0 and<br>Ø6.5 |
| Gingival Height | 1.8, 2.8, 3.8 and 4.8mm | 0.8, 1.3, 1.8, 2.3, 3.3, 4.3<br>and 5.3mm | 0.8, 1.3, 1.8, 2.3, 3.3, 4.3<br>and 5.3mm |
| Length | 8.3, 8.44, 9.3, 9.44, 9.8,<br>9.94, 10.3, 10.44, 10.8,<br>10.94, 11.3, 11.44, 11.8,<br>11.94, 12.3, 12.44, 12.8,<br>12.94, 13.3 13.44, 14.3<br>and 14.44mm | 7.3, 7.44, 7.8, 7.94, 8.3,<br>8.44, 8.8, 8.94, 9.3, 9.44,<br>9.8, 9.94, 10.3, 10.44, 10.8,<br>10.94, 11.3, 11.44, 11.8,<br>11.94, 12.3, 12.44, 12.8,<br>12.94, 13.3, 13.44, 13.8,<br>13.94, 14.8 and 14.94mm | 7.3, 7.44, 7.8, 7.94, 8.3,<br>8.44, 8.8, 8.94, 9.3, 9.44,<br>9.8, 9.94, 10.3, 10.4, 10.44,<br>10.8, 10.9, 10.94, 11.3, 11.4,<br>11.44, 11.8, 11.9, 11.94,<br>12.3, 12.44, 12.8, 12.9,<br>12.94, 13.3, 13.44, 13.8,<br>13.9, 13.94, 14.8, 14.9 and<br>14.94mm |
| Coating | Non / TiN Coating | TiN Coating | Non |
| Material | Ti-6Al-4V ELI<br>(ASTM F136) | Ti-6Al-4V ELI<br>(ASTM F136) | Ti-6Al-4V ELI<br>(ASTM F136) |
| Sterilization | End User Sterilization | End User Sterilization | End User Sterilization |
| Comparison | Subject Device and Reference Devices, K171694 and K171027 have same indications<br>sterilization and material, and similar dimensions. The subject device has two types of<br>surface coating, non-coating and TiN coating. K171027 is selected for non-coating<br>abutment and K171694 is selected for TiN coating abutment as predicates. The subject<br>device is substantial equivalent. | | |
# s-Clean Couple Abutment s-Line & s-Clean TiN Half Coating Couple Abutment s-Line
{9}------------------------------------------------
| | Subject Device | Reference Device | Reference Device |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|-------------------------------------------|
| K number | NA | K171694 | K082843 |
| Manufacturer | Dentis Co., Ltd | Dentis Co., Ltd | Dentis Co., Ltd |
| Trade Name | Dentis s-Clean s-Line | s-Clean TiN Coating<br>Abutment | s-Clean TiN Coating<br>Abutment |
| Model Name | s-Clean Angled Abutment s-Line / s-Clean<br>TiN Half Coating Angled Abutment s-Line | s-Clean TiN Half<br>Coating Angled<br>Abutment | s-Clean Angled<br>Abutment |
| Design | Image: Design of subject device | Image: Design of reference device K171694 | Image: Design of reference device K082843 |
| Diameter | Ø4.5, 5.5 and 6.5 | Ø4.5, 5.0,5.5 and Ø6.5 | Ø4.5, 5.0,5.5 and<br>Ø6.5 |
| Gingival<br>Height | 2.8 and 3.8 | 0.8, 1.8 and 3.8mm | 1.8 and 3.8mm |
| Length | 12.04, 12.18, 12.46, 12.6, 13.04, 13.18, 13.46<br>and 13.6mm | 10.18, 10.4, 10.46,<br>10.6, 11.18, 11.6, 12.4,<br>13.18 and 13.6 | 10.54 and 12.54mm |
| Angulation | 15° and 25° | 15° and 25° | 15° and 25° |
| Coating | Non / TiN Coating | TiN Coating | Non |
| Material | Ti-6Al-4V ELI<br>(ASTM F136) | Ti-6Al-4V ELI<br>(ASTM F136) | Ti-6Al-4V ELI<br>(ASTM F136) |
| Sterilization | End User Sterilization | End User Sterilization | End User<br>Sterilization |
| Comparison | Subject Device and Reference Devices, K171694 and K082843 have same indications<br>sterilization and material, and similar dimensions. The subject device has two types of surface<br>coating, non-coating and TiN coating. K082843 is selected for non-coating abutment and<br>K171694 is selected for TiN coating abutment as predicates. The subject device is substantial<br>equivalent. | | |
#### s-Clean Angled Abutment s-Line & s-Clean TiN Half Coating Angled Abutment s-Line
### s-Clean Abutment Screw s-Line
| | Subject Device | Reference Device |
|---------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|
| K number | NA | K171027 |
| Manufacturer | Dentis Co., Ltd | Dentis Co., Ltd |
| Trade Name | Dentis s-Clean s-Line | s-Clean TiN Coating Abutment |
| Model Name | s-Clean Abutment Screw s-Line | s-Clean Abutment Screw |
| Design | Image: Subject Device Design | Image: Reference Device Design |
| Head Diameter | $Ø$ 2.32 | $Ø$ 2.32 |
| Length | 9.4mm | 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, K171027 have same indications for use, diameter,<br>and material. The difference between two devices is the length, however it doesn't impact<br>device performance. The subject device is substantial equivalent. | |
{10}------------------------------------------------
# s-Clean MU Straight Abutment
| | 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 | Dentis Dental Implant System | s-Clean TiN Coating<br>Abutment | |
| Model Name | s-Clean MU Straight<br>Abutment | MU Solid Abutment / MU<br>Couple Abutment | s-Clean TiN Half Coating<br>Couple Abutment | |
| Design | Image: s-Clean MU Straight Abutment | Image: MU Solid Abutment / MU Couple Abutment | Image: s-Clean TiN Half Coating Couple Abutment | |
| Diameter | Ø4.8 | Ø4.8 | Ø4.5, 4.8, 5.5, 6.0 and Ø6.5 | |
| Length | 9.3, 10.3, 11.3, 12.3 and<br>13.3mm | 6.08, 8.08, 6.69, 8.69, 9.2,<br>10.2, 11.2 and 12.2mm | Cuff-2, 37.3, 7.44, 7.8, 7.94,<br>8.3, 8.44, 8.8, 8.94, 9.3, 9.44,<br>9.8, 9.94, 10.3, 10.44, 10.8,<br>10.94, 11.3, 11.44, 11.8,<br>11.94, 12.3, 12.44, 12.8,<br>12.94, 13.3, 13.44, 13.8,<br>13.94, 14.8 and 14.94mm, 4,<br>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 indications,diameter, angulation,<br>material and sterilization method. Differences are length and coating. But the coating feature is<br>explained with Reference Device, K71694 that has same TiN coating and the length of the<br>subject device is in range of the length of K171694. Thus, the subject device is substantial<br>equivalent. | | | |
# s-Clean MU Angled Abutment
| | Subject Device | Reference Device | Reference Device | |
|---------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|----------------------------------------------------------------|--|
| K number | NA…
