(90 days)
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.
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 device includes various abutments made from Ti-6A1-4V (ASTM F136) and Chrome-cobalt-molybdenum (CCM) alloy material (ASTM F1537). Some abutments have a TiN coating. Some components are provided sterile, while others are non-sterilized.
The provided text describes a 510(k) premarket notification for a dental implant system (Dentis s-Clean s-Line). This document primarily focuses on establishing substantial equivalence to previously cleared predicate devices. Therefore, it does not present a typical device performance study with specific acceptance criteria and reported numerical performance metrics.
Instead, the "acceptance criteria" can be inferred as demonstration of substantial equivalence to predicate devices through various tests and comparisons, particularly in terms of:
- Indications for Use
- Design and dimensions
- Materials
- Surface treatments
- Sterilization methods
- Biocompatibility
- Dynamic fatigue and static strength
The "study that proves the device meets the acceptance criteria" is fundamentally the comparative analysis against the predicate and reference devices, along with performance testing (dynamic fatigue, static strength) and biological assessment (biocompatibility).
Here's an attempt to structure the information based on your request, acknowledging that the format of a 510(k) summary is different from a clinical study report.
Implied Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission, the primary "acceptance criterion" is demonstrating substantial equivalence to legally marketed predicate devices. The performance data presented is in comparison to these predicates rather than against pre-defined numerical thresholds for novel performance.
| Acceptance Criteria (Implied for Substantial Equivalence to Predicates) | Reported Device Performance (as demonstrated by comparison/testing) |
|---|---|
| Mechanical Performance: - Dynamic Fatigue Strength- Static Strength | Tests conducted according to FDA guidance and ISO 14801:2016 for worst-case scenario. Results are implied to be equivalent to predicate (as no significant differences were cited to impact performance). |
| Material Characteristics: - Adherence to ASTM standards (F67, F136, F1537)- Surface characteristics (SLA, TiN coating) | Fixtures made of CP Titanium Gr4 (ASTM F67). Abutments from Ti-6Al-4V (ASTM F136) and Chrome-cobalt-molybdenum (ASTM F1537). SLA surface identical to K153639. TiN coating identical to K171694. EDX, SEM, surface roughness, coating thickness, porosity, adhesion leveraged from predicates. |
| Biocompatibility: - Non-cytotoxic, non-sensitizing, non-irritating | Biological assessment performed according to ISO 10993-1:2009 and FDA Guidance. Device has equivalent nature of body contact, duration, material formulation, and sterilization methods compared to predicates, thus no new issues raised. |
| Sterilization: - Sterility Assurance Level (SAL) of 10^-6- Shelf Life Validation- Pyrogenicity | Validated in accordance with ISO 11137-1:2006. Shelf life of 8 years for sterile devices, validated per ASTM F1980. LAL Endotoxin Analysis (testing limit 20 EU/device) meets pyrogen limit specifications. |
| Dimensional Tolerance: - Fixtures and Abutments | Stated tolerance of ± 1% range for dimensions. The dimensions of the subject device are stated to be "in range" or "similar" to the predicate devices and not to impact device performance. |
Detailed Information as Requested:
-
A table of acceptance criteria and the reported device performance: (See table above).
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document does not specify a "test set" in the context of a clinical study or human subject data. The samples for mechanical testing (dynamic fatigue, static strength) and biocompatibility are laboratory samples/implants, not patient data.
- The document does not provide details on the number of samples used for these specific tests.
- Data Provenance: The mechanical and surface characteristic data were leveraged from previous clearances (K153639, K171694, K082843, K150344, K171027), indicating prior existing test results. It is prospective testing for the elements that are different or new, but retrospective use of data for elements deemed identical to predicates. Country of origin for testing is not specified.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This question is not applicable to a 510(k) submission based on mechanical and biocompatibility testing. There is no "ground truth" established by experts in the clinical sense for this type of submission. The "ground truth" for material properties and mechanical performance would be the universally accepted standards (ASTM, ISO) and the empirical results of the tests themselves, interpreted by qualified engineers/scientists.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This type of adjudication method is used in clinical trials or diagnostic accuracy studies involving expert panel reviews, which are not part of this 510(k) submission for mechanical equivalence.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This pertains to AI/CAD devices, not dental implants. No MRMC study was conducted or relevant to this submission.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This pertains to AI/CAD devices, not dental implants.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the mechanical and material aspects, the "ground truth" is defined by international standards (ISO, ASTM) and regulatory guidance (FDA Guidance Documents) for dental implants. The device components are compared against these established specifications and the validated characteristics of the predicate devices.
- For biocompatibility, the ground truth is established by recognized biological evaluation standards (ISO 10993-1).
-
The sample size for the training set:
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
-
How the ground truth for the training set was established:
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
{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: 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.
{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 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) 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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{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
- 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
{4}------------------------------------------------
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-Line | Ø4.8, 5.8, 6.8 and 7.8 (D) x 8.2, 9.2, 10.2, 11.2, 12.2, 13.2and 15.2mm (L) | 0° |
| 2 | s-Clean Sole Abutment s-Line | Ø4.5, 5.5 and 6.5 (D) x 13.1, 14.1, 14.6, 15.1, 15.6, 16.1,16.6 and 17.6mm (L) | 0° |
| 3 | s-Clean TiN Half CoatingSole Abutment s-Line | Ø4.5, 5.5 and 6.5 (D) x 13.1, 14.1, 14.6, 15.1, 15.6, 16.1,16.6 and 17.6mm (L) | 0° |
| 4 | s-Clean 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, 10.3,10.44, 10.8, 10.94, 11.3, 11.44, 11.8, 11.94, 12.3, 12.44,12.8, 12.94, 13.3 13.44, 14.3 and 14.44mm (L) | 0° |
| 5 | s-Clean TiN Half CoatingCouple Abutment s-Line | Ø4.5, 5.5 and 6.5 (D) x 8.3, 8.44, 9.3, 9.44, 9.8, 9.94, 10.3,10.44, 10.8, 10.94, 11.3, 11.44, 11.8, 11.94, 12.3, 12.44,12.8, 12.94, 13.3 13.44, 14.3 and 14.44mm (L) | 0° |
| 6 | s-Clean Angled Abutment s-Line | Ø4.5, 5.5 and 6.5 (D) x 12.04, 12.18, 12.46, 12.6, 13.04,13.18, 13.46 and 13.6mm (L) | 15°, 25° |
| 7 | s-Clean TiN Half CoatingAngled Abutment s-Line | Ø4.5, 5.5 and 6.5 (D) x 12.04, 12.18, 12.46, 12.6, 13.04,13.18, 13.46 and 13.6mm (L) | 15°, 25° |
| 8 | s-Clean Abutment Screw s-Line | Ø2.32 (D) x 9.4mm (L) | 0° |
| 9 | s-Clean MU StraightAbutment | Ø4.8 (D) x 9.3, 10.3, 11.3, 12.3 and 13.3mm (L) | 0° |
| 10 | s-Clean MU AngledAbutment | Ø4.8 (D) x 7.09, 7.58, 8.09, 8.58, 9.09, 9.58, 10.09 and10.58mm (L) | 17°, 30° |
| 11 | s-Clean MU AngledAbutment 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 TemporaryCylinder | 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:
{5}------------------------------------------------
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 SoleAbutment 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 CoupleAbutment s-Line | TiN-Coating | ||
| s-Clean Angled Abutment s-Line | Non | ||
| s-Clean TiN Half Coating AngledAbutment s-Line | TiN-Coating | ||
| s-Clean Abutment Screw s-Line | This screw is used for connect fixture and abutment | Non | Internal Hex2.5 |
| 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).
{6}------------------------------------------------
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 usein partially or fully edentulous mandiblesand maxillae, in support of single ormultiple unit restorations including;cemented retained, screw retained, oroverdenture restorations, and terminal orintermediate abutment support for fixedbridework. This system is dedicated forone and two stage surgical procedures.This system is intended for delayedloading. | The OneQ-SL s-Clean Implant System isindicated for use in partially or fullyedentulous mandibles and maxillae, insupport of single or multiple unitrestorations including; cemented retained,screw retained, or overdenturerestorations, and terminal or intermediateabutment support for fixedbridework. This system is dedicated forone and two stage surgical procedures.This system is intended for delayedloading. |
| 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 asIndications for Use, surface treatment, material, abutment connection, and sterilization. Thedifference between two devices is the dimensions and external thread design. The differencein dimensions is due to the change in external thread design. Since the dimensions of thesubject device are in range of the dimensions of the predicate, it doesn't impact deviceperformance. Therefore, subject device and predicate device are substantially equivalent. |
{7}------------------------------------------------
| 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-Line / s-Clean TiN HalfCoating Sole Abutment s-Line | s-Clean TiN Partial CoatingSole 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 | |
| GingivalHeight | 1.8, 2.8, 3.8 and 4.8mm | 0.8, 1.3, 1.8, 2.3, 3.3, 4.3 and5.3mm | 0.8, 1.3, 1.8, 2.3, 3.3, 4.3, and5.3mm | |
| Length | 13.1, 14.1, 14.6, 15.1, 15.6,16.1, 16.6 and 17.6mm | 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 and18.5mm | 12.5, 13.0, 13.5, 14.0, 15.0, 16.0and 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 indicationssterilization and material, and similar dimensions. The subject device has two types of surfacecoating, non-coating and TiN coating. K171027 is selected for non-coating abutment andK171694 is selected for TiN coating abutment as predicates. The subject device is substantialequivalent. |
{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 | s-Clean TiN CoatingAbutment | Dentis Dental ImplantSystem |
| Model Name | s-Clean Couple Abutments-Line / s-Clean TiN HalfCoating CoupleAbutment s-Line | s-Clean TiN Half CoatingCouple 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 andØ6.5 |
| Gingival Height | 1.8, 2.8, 3.8 and 4.8mm | 0.8, 1.3, 1.8, 2.3, 3.3, 4.3and 5.3mm | 0.8, 1.3, 1.8, 2.3, 3.3, 4.3and 5.3mm |
| Length | 8.3, 8.44, 9.3, 9.44, 9.8,9.94, 10.3, 10.44, 10.8,10.94, 11.3, 11.44, 11.8,11.94, 12.3, 12.44, 12.8,12.94, 13.3 13.44, 14.3and 14.44mm | 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, 11.8,11.94, 12.3, 12.44, 12.8,12.94, 13.3, 13.44, 13.8,13.94, 14.8 and 14.94mm | 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, 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 and14.94mm |
| 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 indicationssterilization and material, and similar dimensions. The subject device has two types ofsurface coating, non-coating and TiN coating. K171027 is selected for non-coatingabutment and K171694 is selected for TiN coating abutment as predicates. The subjectdevice 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 CoatingAbutment | s-Clean TiN CoatingAbutment |
| Model Name | s-Clean Angled Abutment s-Line / s-CleanTiN Half Coating Angled Abutment s-Line | s-Clean TiN HalfCoating AngledAbutment | s-Clean AngledAbutment |
| 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 andØ6.5 |
| GingivalHeight | 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, 13.46and 13.6mm | 10.18, 10.4, 10.46,10.6, 11.18, 11.6, 12.4,13.18 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(ASTM F136) | Ti-6Al-4V ELI(ASTM F136) | Ti-6Al-4V ELI(ASTM F136) |
| Sterilization | End User Sterilization | End User Sterilization | End UserSterilization |
| Comparison | Subject Device and Reference Devices, K171694 and K082843 have same indicationssterilization and material, and similar dimensions. The subject device has two types of surfacecoating, non-coating and TiN coating. K082843 is selected for non-coating abutment andK171694 is selected for TiN coating abutment as predicates. The subject device is substantialequivalent. |
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,and material. The difference between two devices is the length, however it doesn't impactdevice 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 CoatingAbutment | |
| Model Name | s-Clean MU StraightAbutment | MU Solid Abutment / MUCouple Abutment | s-Clean TiN Half CoatingCouple 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 and13.3mm | 6.08, 8.08, 6.69, 8.69, 9.2,10.2, 11.2 and 12.2mm | Cuff-2, 37.3, 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, 11.8,11.94, 12.3, 12.44, 12.8,12.94, 13.3, 13.44, 13.8,13.94, 14.8 and 14.94mm, 4,5mm | |
| 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,material and sterilization method. Differences are length and coating. But the coating feature isexplained with Reference Device, K71694 that has same TiN coating and the length of thesubject device is in range of the length of K171694. Thus, the subject device is substantialequivalent. |
s-Clean MU Angled 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 Abutment | |
| Model Name | s-Clean MU AngledAbutment | MU Angled Abutment | s-Clean TiN Half CoatingAngled Abutment | |
| Design | Image: abutment | Image: abutment | Image: abutments | |
| Diameter | $Ø4.8$ | $Ø4.8$ | $Ø4.5, 5.0, 5.5$ and $Ø6.5$ | |
| Length | 7.09, 7.58, 8.09, 8.58, 9.09,9.58, 10.09 and 10.58mm | 6.08, 8.08, 6.69 and 8.69mm | 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 | 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,material and sterilization method. Differences are length and coating. But the coating feature isexplained with Reference Device, K71694 that has same TiN coating and the length of the subjectdevice is in range of the length of K171694. Thus, the subject device is substantial equivalent. |
{11}------------------------------------------------
| s-Clean MU Angled Abutment Screw | ||||
|---|---|---|---|---|
| -- | -- | -- | ---------------------------------- | -- |
| Subject Device | Reference Device | ||
|---|---|---|---|
| K number | NA | K150344 | |
| Manufacturer | Dentis Co., Ltd | Dentis Co., Ltd | |
| Trade Name | Dentis s-Clean s-Line | Dentis Dental Implant System | |
| Model Name | s-Clean MU Angled Abutment Screw | MU Abutment Screw | |
| Design | Image: s-Clean MU Angled Abutment Screw | Image: MU Abutment Screw | |
| Head Diameter | Ø1.96 | Ø1.96 and 2.32 | |
| Length | 8.08 | 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 for use andmaterial. The diameter and length are different but this difference is not important factor tothe device performance. The subject device is substantial equivalent. |
s-Clean MU Cylinder Screw
| Subject Device | Reference Device | |
|---|---|---|
| K number | NA | K150344 |
| Manufacturer | Dentis Co., Ltd | Dentis Co., Ltd |
| Trade Name | Dentis s-Clean s-Line | Dentis Dental Implant System |
| Model Name | s-Clean MU Cylinder Screw | s-Clean Retaining Screw |
| Design | Image: s-Clean MU Cylinder Screw | Image: s-Clean Retaining Screw |
| Head Diameter | $\text{\u00f8}1.97$ | $\text{\u00f8}1.98$ |
| Length | 3.8mm | 3.7mm |
| Material | Ti-6Al-4V ELI (ASTM F136) | Ti-6Al-4V ELI (ASTM F136) |
| Sterilization | Steam sterilization by User | Steam sterilization by User |
| Comparison | Subject Device and Reference Device, K150344 have same indications for use andmaterial. The diameter and length are different but this difference is not important factor tothe device performance. The subject device is substantial equivalent. |
s-Clean MU Healing Cap
| Subject Device | Reference Device | |
|---|---|---|
| K number | NA | K150344 |
| Manufacturer | Dentis Co., Ltd | Dentis Co., Ltd |
| Trade Name | Dentis s-Clean s-Line | Dentis Dental Implant System |
| Model Name | s-Clean MU Healing Cap | MU Healing Cap |
| Design | Image: s-Clean MU Healing Cap | Image: MU Healing Cap |
| Diameter | Ø4.8 | Ø5.4 |
| Length | 4.1mm | 5.0mm |
| 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 for use andmaterial. The diameter and length are different but this difference is not important factor tothe device performance. The subject device is substantial equivalent. |
{12}------------------------------------------------
s-Clean MU Temporary Cylinder
| Subject Device | Reference Device | ||
|---|---|---|---|
| K number | NA | K150344 | |
| Manufacturer | Dentis Co., Ltd | Dentis Co., Ltd | |
| Trade Name | Dentis s-Clean s-Line | Dentis Dental Implant System | |
| Model Name | s-Clean MU Temporary Cylinder | MU Temporary Cylinder | |
| Design | Image: Subject Device Design | Image: Reference Device Design | |
| Diameter | Ø 4.8 | Ø 4.8 | |
| Length | 12mm | 10.0mm | |
| Material | CP Titanium Gr4 (ASTM F67) | CP Titanium Gr4 (ASTM F67) | |
| Sterilization | End User Sterilization | End User Sterilization | |
| Comparison | Subject Device and Reference Device, K150344 have same indications, diameter andmaterial. The length is different but this difference is not important factor to the deviceperformance because this device is used temporary. The subject device is substantialequivalent. |
s-Clean MU CCM Cylinder
| Subject Device | Reference Device | |
|---|---|---|
| K number | NA | K150344 |
| Manufacturer | Dentis Co., Ltd | Dentis Co., Ltd |
| Trade Name | Dentis s-Clean s-Line | Dentis Dental Implant System |
| Model Name | s-Clean MU CCM Cylinder | MU CCM Cylinder |
| Description | Image: Subject Device | Image: Reference Device |
| Diameter | $Ø$ 4.9 | $Ø$ 4.8 |
| Length | 14mm | 14.25mm |
| Material | Body : Cobalt-Chrome-molybdenum Alloy(ASTM F1537)Sleeve: Acetal | Body : Cobalt-Chrome-molybdenum Alloy(ASTM F1537)Sleeve : Acetal |
| Sterilization | Steam sterilization by User | Steam sterilization by User |
| Comparison | Subject Device and Reference Device, K150344 have same indications and material. Thediameter and length are different but this difference is not important factor to the deviceperformance. The subject device is substantial equivalent. |
{13}------------------------------------------------
Performance Data
Dynamic fatigue and static strength tests were conducted according to the FDA guidance document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form EndosseousDental Implants and Endosseous Dental Abutments" and ISO 14801:2016, "Dentistry – Implants – Dynamic fatigue test for endosseous dental implants" under the worst-case scenario.
Surface modification information according to the recommendations of the FDA guidance document, "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments", was leveraged from prior clearances.
The SLA (Sandblasted with Large-grit and Acid-etching) surface modification for the fixtures is identical to the primary predicate K153639. Thus, SLA (Sandblasted with Large-grit and Acidetching) surface modification information to evaluate the fixture surface characteristics after SLA treatment (i.e., EDX chemical analysis of the surface, Scanning Electron Microscope analysis), was leveraged from the primary predicate K153639.
The subject device TiN coating for the subject s-Clean TiN Half Coated Abutments is identical to the surface treatment for the reference device, K171694. Thus, TiN (Titanium Nitride) coating information (i.e., EDS chemical composition analysis, scanning electron microscopy analysis, surface roughness, coating thickness and porosity, adhesion) was leveraged from the reference device, K171694.
Biocompatibility Testing
Biological assessment has been performed according to ISO 10993-1:2009, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process," and to fDA Guidance document, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process', Guidance for Industry and Food andDrug Administration Staff", Document issued on: June 16, 2016", for each of the subject devices.
The subject devices have equivalent nature of body contact, contact duration, material formulation, and sterilization methods compared to the primary predicate and reference devices, therefore, no new issues regarding biocompatibility were raised.
Sterilization Validation and Packaging
The sterilization process for the Dentis s-Clean s-Line Implant system as recommended in the labeling was validated according to:
For devices delivered sterile (Dentis s-Clean s-Line implants and Healing abutments) - a sterility assurancelevel (SAL) of 10 ° have been validated in accordance with ISO 11137-1:2006, Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.
The validation method used was the bioburden method in accordance with ISO 11137-2:2013, Sterilizationof health care products - Radiation - Part 2: Establishing the sterilization dose. Shelf Life validation was performed in accordance with ASTM F1980, Standard Guide for Accelerated Aging of Sterile Medical Device Packages. The worst-case construct was tested, and results demonstrated equivalence to the predicate devices. The shelf life for devices provided sterile is 8 years. The devices will not be marketed as non-pyrogenic.
Pyrogenicity information provided is based on FDA Guidance on "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submission for Devices Labeled as Sterile, issued on 21 January 2016." The method used to determine the device meets pyrogen limit specifications is LAL Endotoxin Analysis with testing limit of 20 EU/device, based on a blood contacting and implanted device.
§ 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.