Dentis s-Clean s-Line Mini
Device Facts
| Record ID | K210080 |
|---|---|
| Device Name | Dentis s-Clean s-Line Mini |
| Applicant | Dentis Co., Ltd. |
| Product Code | DZE · Dental |
| Decision Date | Jun 4, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3640 |
| Device Class | Class 2 |
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.
Device Story
Dental implant system comprising fixtures and abutments; placed in alveolar bone to replace missing teeth. Fixtures feature SLA surface treatment (sandblasted, large-grit, acid-etched) and internal hex connection. System utilizes two-screw-joint design for diverse abutment compatibility (1.6M or 2.0M screws). Components include cover screws, healing abutments, sole/couple abutments (some TiN-coated), angled abutments, and temporary abutments. Used by dental professionals in clinical settings for surgical tooth replacement. Output is a stable foundation for prosthetic restorations. Benefits include restoration of tooth function and aesthetics. Fixtures and select components provided sterile; others require end-user sterilization.
Clinical Evidence
Bench testing only. Fatigue testing performed per ISO 14801:2016 under worst-case scenarios. Biocompatibility, sterilization, and shelf-life data were leveraged from predicate devices (K153639, K171027, K171694, K192688, K111364) based on identical materials, manufacturing processes, and packaging. Surface modification (SLA) equivalence confirmed via surface roughness, composition analysis, and SEM imaging compared to predicate K153639.
Technological Characteristics
Materials: Pure titanium (ASTM F67) for fixtures/cover screws; Ti-6Al-4V ELI (ASTM F136) for abutments; PEEK for temporary abutments. Surface: SLA (sandblasted, large-grit, acid-etched) on fixtures; TiN coating on select abutments. Connection: Internal hex with dual screw-joint design. Sterilization: Gamma irradiation (fixtures) or end-user (abutments). Dimensions: Fixture diameters Ø5.8-7.8mm; abutment angulations 0°-30°.
Indications for Use
Indicated for partially or fully edentulous adult patients requiring single or multiple unit dental restorations, including cemented, screw-retained, or overdenture restorations, and fixed bridgework support. 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
- Dentis Dental Implant System (K153639)
Reference Devices
- Luna Dental Implant System (K123155)
- AnyOne Internal Implant System (K123988)
- Dentis Dental Implant System (K150344)
- OSSTEM Implant System - Abutment (K161689)
- Dentis Dental Implant System (K171027)
- s-Clean TiN Coating Abutment (K171694)
- Healing Abutments and Cover Screws (K192436)
- s-Clean SQ-SL Implant System Mini (K200099)
- s-Clean SO-SL Implant System Mini (K202773)
Submission Summary (Full Text)
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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.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) 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) | |
|------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|
| <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CER 801 Subpart D) | <span style="">□</span> Over-The-Counter Use (21 CER 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 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
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### 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<br>Mini | Ø4.3, 4.8 and 5.8 (D) X 7.61, 8.61, 9.61, 10.61, 11.61,<br>12.61 and 14.61mm (L) | 0° |
| 3 | s-Clean Sole Abutment s-Line<br>Mini | Ø4.5 and 5.5 (D) X 11.01, 12.01, 12.51, 13.01, 13.51,<br>14.01, 14.51, 15.01, 15.51, 16.01 and 17.01mm (L) | 0° |
| 4 | s-Clean TiN Half Coating Sole<br>Abutment s-Line Mini | Ø4.5 and 5.5 (D) X 11.01, 12.01, 12.51, 13.01, 13.51,<br>14.01, 14.51, 15.01, 15.51, 16.01 and 17.01mm (L) | 0° |
| 5 | s-Clean Couple Abutment s-Line<br>Mini | Ø4.0, 4.5 and 5.5 (D) X 8.35, 8.6, 9.35, 9.6, 9.85, 10.1,<br>10.35, 10.6, 10.85, 11.1, 11.35, 11.6, 11.85, 12.1, 12.35,<br>12.6, 12.85, 13.1, 13.35, 13.6, 14.35 and 14.6mm (L) | 0° |
| 6 | s-Clean TiN Half Coating Couple<br>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,<br>10.35, 10.6, 10.85, 11.1, 11.35, 11.6, 11.85, 12.1, 12.35,<br>12.6, 12.85, 13.1, 13.35, 13.6, 14.35 and 14.6mm (L) | 0° |
| 7 | s-Clean Angled Abutment s-Line<br>Mini | Ø4.0, 4.5 and 5.5 (D) X 12.09, 12.34, 12.51, 12.76,<br>13.09, 13.34, 13.51 and 13.76mm (L) | 15° and 25° |
| 8 | s-Clean TiN Half Coating Angled<br>Abutment s-Line Mini | Ø4.0, 4.5 and 5.5 (D) X 12.09, 12.34, 12.51, 12.76,<br>13.09, 13.34, 13.51 and 13.76mm (L) | 15° and 25° |
| 9 | s-Clean Abutment Screw s-Line<br>Mini | Ø2.03 (D) X 10.2mm (L) | 0° |
| 10 | s-Clean Temporary Abutment<br>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<br>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:
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| 12 | s-Clean MU Angled Abutment<br>Mini | Ø1.56 (D) X 7.25, 7.74, 8.25, 8.74, 9.25, 9.74, 10.25<br>and 10.74mm (L) | 17° and 30° |
|----|------------------------------------------|--------------------------------------------------------------------------|-------------|
| 13 | s-Clean MU Angled Abutment<br>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<br>connecting part with exposed upper part<br>of structure during the healing period after<br>inserting dental implant fixture | Anodizing<br>(Gold Color) | Screw<br>Retained |
| s-Clean Healing Abutment<br>s-Line Mini | The healing Abutment is used for<br>protecting inner hole of fixture and<br>adjusting the appropriate height during the<br>healing period | Anodizing<br>(Gold Color) | Screw<br>Retained |
| s-Clean Sole Abutment s-Line Mini | | N/A | |
| s-Clean TiN Half Coating Sole<br>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<br>and it supports prosthesis which restores<br>tooth function. | N/A | |
| s-Clean TiN Half Coating Couple<br>Abutment s-Line Mini | The Abutment is connected with fixture | TiN-Coating | Internal Hex |
| s-Clean Angled Abutment s-Line<br>Mini | The Abutment is connected with fixture<br>and it supports prosthesis which restores<br>tooth function | N/A | |
| s-Clean TiN Half Coating Angled<br>Abutment s-Line Mini | | TiN-Coating | Internal Hex |
| s-Clean Abutment Screw s-Line Mini | This screw is used for connect fixture and<br>abutment | N/A | Screw<br>Retained |
| s-Clean Temporary Abutment Mini | This Abutment is used for prosthetic<br>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<br>angulation. | TiN-Coating | Internal Hex |
| s-Clean MU Angled Abutment Screw<br>Mini | This Screw is used for fixture and MU<br>Angled Abutment | N/A | Screw<br>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. ●
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# 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<br>Mini | Dentis Dental Implant<br>System | s-Clean SQ-SL Implant System<br>Mini | |
| Design | Image: Dentis s-Clean s-Line Mini | Image: Dentis Dental Implant System | Image: s-Clean SQ-SL Implant System Mini | |
| Indications for<br>Use | Dentis s-Clean s-Line<br>Mini is indicated for use<br>in partially or fully<br>edentulous mandibles and<br>maxillae, in support of<br>single or multiple unit<br>restorations including;<br>cemented retained, screw<br>retained, or overdenture<br>restorations, and terminal<br>or intermediate abutment<br>support for fixed<br>bridgework. This system<br>is dedicated for one and<br>two stage surgical<br>procedures. This system is<br>intended for delayed<br>loading. | The OneQ-SL s-Clean<br>Implant System is<br>indicated for use in<br>partially or fully<br>edentulous mandibles and<br>maxillae, in support of<br>single or multiple unit<br>restorations including;<br>cemented retained, screw<br>retained, or overdenture<br>restorations, and terminal<br>or intermediate abutment<br>support for fixed<br>bridgework. This system is<br>dedicated for one and two<br>stage surgical procedures<br>and not dedicated for<br>immediate loading. This<br>system is intended for<br>delayed loading | s-Clean SQ-SL Implant System<br>Mini is indicated for use in<br>partially or fully edentulous<br>mandibles and maxillae, in<br>support of single or multiple unit<br>restorations including; cemented<br>retained, screw retained, or<br>overdenture restorations, and<br>terminal or intermediate<br>abutment support for fixed<br>bridgework. This system is<br>dedicated for one and two stage<br>surgical procedures.<br>This system is intended for<br>delayed loading. | |
| Diameter | Ø5.8, 6.8 and 7.8 | Ø3.7, 3.9, 4.2, 4.7, 5.2, 6.0,<br>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<br>Treatment | SLA | SLA | SLA | |
| Material | CP Titanium Gr4 (ASTM<br>F67) | CP Titanium Gr4 (ASTM<br>F67) | CP Titanium Grade4 (ASTM<br>F67) | |
| Sterilization | Gamma Irradiation | Gamma Irradiation | Gamma Irradiation | |
| Comparison | The Subject Device and primary predicate have same characteristics such as indications for<br>Use, design, diameter, length, surface treatment, material, abutment connection, and<br>sterilization.<br>The difference between subject and primary predicate is only design of screw joint between<br>fixture and abutment. Subject device has two screw-joint of fixture and abutment but primary<br>predicate has only one screw-joint of fixture and abutment. This difference is mitigated<br>through our own device, K202773. Any differences in technology characteristics are<br>accompanied by information that demonstrated the device is substantially equivalent as the<br>predicate and do not raise different questions of safety and effectiveness than the predicate. | | | |
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# 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.,<br>Ltd |
| Trade Name | Dentis s-Clean s-Line Mini | Dentis Dental Implant System | Luna Dental Implant<br>System |
| Model | s-Clean Healing Abutment s-<br>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,<br>7.0 and 7.5 | Ø4.5~7.0 |
| Length | 7.61, 8.61, 9.61, 10.61, 11.61,<br>12.61 and 14.61mm | 9.5, 10.0, 10.5, 11.0, 11.5, 12.0,<br>12.5, 13.0, 13.5 and 14.0mm | 2.0, 3.5, 5.0 and 7.0 |
| Coating | Anodizing (Gold Color) | Non | Anodizing<br>(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<br>and length are different from K171027 but this difference is not important factor to the device<br>performance. Subject device is anodized to make a division according to device size. This<br>difference about surface coating is explained through Reference Device, K123155. Therefore, the<br>subject device is substantial 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<br>Mini | s-Clean TiN Coating Abutment | Dentis Dental Implant<br>System |
| Model | s-Clean Sole<br>Abutment s-Line Mini<br>& s-Clean TiN Half<br>Coating Sole<br>Abutment s-Line Mini | s-Clean TiN Partial Coating Sole<br>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<br>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,<br>4.3, and 5.3 |
| Length | 11.01, 12.01, 12.51,<br>13.01, 13.51, 14.01,<br>14.51, 15.01, 15.51,<br>16.01 and 17.01mm | 10.6, 11.0, 11.5, 11.6, 12.0, 12.1,<br>12.5, 13.0, 13.1, 13.5, 13.6, 14.0,<br>14.1, 14.5, 15.0, 15.1, 15.5, 16.0,<br>16.1, 16.5, 16.6, 17.0, 17.1, 17.5,<br>18.1 and 18.5mm | 12.5, 13.0, 13.5, 14.0,<br>15.0, 16.0 and 17.0mm |
| 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 diameter,<br>length, material and sterilization method. 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<br>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<br>Abutment | | Dentis Dental Implant System | |
| Model | s-Clean Couple Abutment<br>s-Line Mini & s-Clean TiN<br>Half Coating Couple<br>Abutment s-Line Mini | | s-Clean TiN Half Coating<br>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<br>and 5.3mm | | 0.8, 1.3, 1.8, 2.3, 3.3, 4.3 and<br>5.3mm | |
| Length | 8.35, 8.6, 9.35, 9.6, 9.85,<br>10.1, 10.35, 10.6, 10.85,<br>11.1, 11.35, 11.6, 11.85,<br>12.1, 12.35, 12.6, 12.85, | | 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, | | 7.3, 7.44, 7.8, 7.94, 8.3, 8.44,<br>8.8, 8.94, 9.3, 9.44, 9.8, 9.94,<br>10.3, 10.4, 10.44, 10.8, 10.9,<br>10.94, 11.3, 11.4, 11.44, 11.8, | |
{9}------------------------------------------------
| | 13.1, 13.35, 13.6, 14.35,<br>14.6 | 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 | 11.9, 11.94, 12.3, 12.44, 12.8,<br>12.9, 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 | 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 diameter, length,<br>material and sterilization method. The subject device has two types of surface coating, non-<br>coating and TiN coating. K171027 is selected for non-coating abutment and K171694 is<br>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<br>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,<br>13.34, 13.51, 13.76, | 10.18, 10.4, 10.46, 10.6,<br>11.18, 11.6, 12.4, 13.18 and<br>13.6 | 7.7~18.7 |
| Angulation | 15° and 25°…
