(90 days)
No
The summary describes a dental implant system made of standard materials and tested using established mechanical and biocompatibility standards. There is no mention of AI, ML, image processing, or data-driven performance metrics.
No
The device is described as an implant system for replacing missing teeth, which is a restorative function, not a therapeutic one. Therapeutic devices are typically used for treating or curing a disease or condition.
No
The device is described as an implant system for replacing missing teeth, which involves surgical procedures and support for restorations. It does not perform any diagnostic function.
No
The device description explicitly states it is composed of physical components (Fixture and Abutments) made of titanium and other alloys, and performance studies include physical tests like dynamic fatigue and static strength.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used in the body (mandibles and maxillae) to support dental restorations. IVDs are used outside the body to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is described as a dental implant system composed of fixtures and abutments made of titanium and other alloys, designed to be placed in bone. This is consistent with a surgical implant, not a diagnostic test.
- No mention of biological specimens: There is no mention of the device being used with or analyzing biological specimens.
- Performance Studies: The performance studies described (dynamic fatigue, static strength, biocompatibility, sterilization, shelf life, pyrogenicity) are typical for implantable medical devices, not IVDs.
Therefore, the Dentis s-Clean s-Line is a dental implant system, which is a type of medical device, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications 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, 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.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
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:
s-Clean SQ-SL Fixture: Ø 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.
The dimensions of abutments are as following:
- 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, 13.2 and 15.2mm (L), Angulation: 0°
- 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), Angulation: 0°
- s-Clean TiN Half Coating 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), Angulation: 0°
- 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), Angulation: 0°
- s-Clean TiN Half Coating 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), Angulation: 0°
- 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), Angulation: 15°, 25°
- s-Clean TiN Half Coating 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), Angulation: 15°, 25°
- s-Clean Abutment Screw s-Line: Ø2.32 (D) x 9.4mm (L), Angulation: 0°
- s-Clean MU Straight Abutment: Ø4.8 (D) x 9.3, 10.3, 11.3, 12.3 and 13.3mm (L), Angulation: 0°
- s-Clean MU Angled Abutment: Ø4.8 (D) x 7.09, 7.58, 8.09, 8.58, 9.09, 9.58, 10.09 and 10.58mm (L), Angulation: 17°, 30°
- s-Clean MU Angled Abutment Screw: Ø1.96 (D) x 8.08mm (L), Angulation: 0°
- s-Clean MU Cylinder Screw: Ø1.97 (D) x 3.8mm (L), Angulation: 0°
- s-Clean MU Healing Cap: Ø4.8 (D) x 4.1mm (L), Angulation: 0°
- s-Clean MU Temporary Cylinder: Ø4.8 (D) x 12mm (L), Angulation: 0°
- s-Clean MU CCM Cylinder: Ø4.9 (D) x 14mm (L), Angulation: 0°
Tolerance of dimension for Abutments shall be within ± 1% range.
The Abutments have below featured:
- s-Clean Healing Abutment s-Line: Used for protecting inner hole of fixture and adjusting the appropriate height during the healing period, Surface: Non, Connection: Not Found
- s-Clean Sole Abutment s-Line: Not Found, Surface: Non, Connection: Not Found
- s-Clean TiN Half Coating Sole Abutment s-Line: Not Found, Surface: TiN-Coating, Connection: Not Found
- s-Clean Couple Abutment s-Line: Connected with fixture and it supports prosthesis which restores tooth function, Surface: Non, Connection: Not Found
- s-Clean TiN Half Coating Couple Abutment s-Line: Not Found, Surface: TiN-Coating, Connection: Not Found
- s-Clean Angled Abutment s-Line: Not Found, Surface: Non, Connection: Not Found
- s-Clean TiN Half Coating Angled Abutment s-Line: Not Found, Surface: TiN-Coating, Connection: Not Found
- s-Clean Abutment Screw s-Line: Used for connect fixture and abutment, Surface: Non, Connection: Internal Hex 2.5
- s-Clean MU Straight Abutment: Useful for various angulation implanted fixture and gingival angulation, Surface: TiN-Coating, Connection: Not Found
- s-Clean MU Angled Abutment: Not Found, Surface: TiN-Coating, Connection: Not Found
- s-Clean MU Angled Abutment Screw: Used for fixture and MU Angled Abutment, Surface: Non, Connection: Not Found
- s-Clean MU Cylinder Screw: Used for cylinder and MU Abutment, Surface: Non, Connection: Not Found
- s-Clean MU Healing Cap: Used for protect the abutment and reduce patient discomfort, Surface: Non, Connection: Not Found
- s-Clean MU Temporary Cylinder: Used for fabricating provisional restoration, Surface: Non, Connection: Not Found
- s-Clean MU CCM Cylinder: Used for screw retained prostheses, Surface: Non, Connection: Not Found
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
partially or fully edentulous mandibles and maxillae
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 10-6 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K082843, K150344, K171027, K171694, K192688
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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, 13.2 | ||
| and 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 Coating | ||
| 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° | ||
| 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 Coating | ||
| 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° | ||
| 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 Coating | ||
| 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° | ||
| 8 | s-Clean Abutment Screw s- | ||
| Line | Ø2.32 (D) x 9.4mm (L) | 0° | |
| 9 | s-Clean MU Straight | ||
| Abutment | Ø4.8 (D) x 9.3, 10.3, 11.3, 12.3 and 13.3mm (L) | 0° | |
| 10 | s-Clean MU Angled | ||
| Abutment | Ø4.8 (D) x 7.09, 7.58, 8.09, 8.58, 9.09, 9.58, 10.09 and | ||
| 10.58mm (L) | 17°, 30° | ||
| 11 | s-Clean MU Angled | ||
| 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 | ||
| 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:
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 Sole | |||
| 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 | |||
| Abutment s-Line | TiN-Coating | ||
| s-Clean Angled Abutment s-Line | Non | ||
| s-Clean TiN Half Coating Angled | |||
| Abutment s-Line | TiN-Coating | ||
| s-Clean Abutment Screw s-Line | This screw is used for connect fixture and abutment | Non | Internal Hex |
| 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).
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 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 | ||
| bridework. This system is dedicated for | ||
| one and two stage surgical procedures. | ||
| This system is intended for delayed | ||
| loading. | The OneQ-SL s-Clean Implant System is | |
| indicated for use in partially or fully | ||
| edentulous mandibles and maxillae, in | ||
| support of single or multiple unit | ||
| restorations including; cemented retained, | ||
| screw retained, or overdenture | ||
| restorations, and terminal or intermediate | ||
| abutment support for fixed | ||
| bridework. This system is dedicated for | ||
| one and two stage surgical procedures. | ||
| This system is intended for delayed | ||
| loading. | ||
| Diameter | Ø5.8, 6.8 and 7.8 | Ø3.7, 3.9, 4.2, 4.7, 5.2, 6.0, 7.0 and 8.0 |
| 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 | |
| Indications for Use, surface treatment, material, abutment connection, and sterilization. The | ||
| difference between two devices is the dimensions and external thread design. The difference | ||
| in dimensions is due to the change in external thread design. Since the dimensions of the | ||
| subject device are in range of the dimensions of the predicate, it doesn't impact device | ||
| performance. 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 Half | ||||
| Coating Sole Abutment s- | ||||
| Line | s-Clean TiN Partial Coating | |||
| 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 | ||||
| Height | 1.8, 2.8, 3.8 and 4.8mm | 0.8, 1.3, 1.8, 2.3, 3.3, 4.3 and | ||
| 5.3mm | 0.8, 1.3, 1.8, 2.3, 3.3, 4.3, and | |||
| 5.3mm | ||||
| Length | 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 and | ||||
| 18.5mm | 12.5, 13.0, 13.5, 14.0, 15.0, 16.0 | |||
| and 17.0mm | ||||
| Coating | Non/Tin Coating | TiN Coating | Non | |
| Material | Ti-6Al-4V ELI | 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 | |||
| sterilization and material, and similar dimensions. The subject device has two types of surface | ||||
| coating, non-coating and TiN coating. K171027 is selected for non-coating abutment and | ||||
| K171694 is selected for TiN coating abutment as predicates. The subject device is substantial | ||||
| equivalent. |
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 Coating | |
| Abutment | Dentis Dental Implant | ||
| System | |||
| Model Name | s-Clean Couple Abutment | ||
| s-Line / s-Clean TiN Half | |||
| Coating Couple | |||
| Abutment s-Line | s-Clean TiN Half Coating | ||
| 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 |
| 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 | |
| and 5.3mm | 0.8, 1.3, 1.8, 2.3, 3.3, 4.3 | ||
| and 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, 14.3 | |||
| and 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 and | |||
| 14.94mm | |||
| 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 indications | ||
| sterilization and material, and similar dimensions. The subject device has two types of | |||
| surface coating, non-coating and TiN coating. K171027 is selected for non-coating | |||
| abutment and K171694 is selected for TiN coating abutment as predicates. The subject | |||
| device is substantial equivalent. |
s-Clean 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 | |
| Abutment | s-Clean TiN Coating | ||
| Abutment | |||
| Model Name | s-Clean Angled Abutment s-Line / s-Clean | ||
| TiN Half Coating Angled Abutment s-Line | s-Clean TiN Half | ||
| Coating Angled | |||
| Abutment | s-Clean Angled | ||
| 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 |
| Ø6.5 | |||
| Gingival | |||
| 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 | ||
| and 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 User |
| Sterilization | |||
| Comparison | Subject Device and Reference Devices, K171694 and K082843 have same indications | ||
| sterilization and material, and similar dimensions. The subject device has two types of surface | |||
| coating, non-coating and TiN coating. K082843 is selected for non-coating abutment and | |||
| K171694 is selected for TiN coating abutment as predicates. The subject device is substantial | |||
| equivalent. |
s-Clean Angled Abutment s-Line & 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 impact | ||
| 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 | |
| Abutment | ||||
| Model Name | s-Clean MU Straight | |||
| Abutment | MU Solid Abutment / MU | |||
| Couple Abutment | s-Clean TiN Half Coating | |||
| 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 | |||
| 13.3mm | 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 is | ||||
| explained with Reference Device, K71694 that has same TiN coating and the length of the | ||||
| subject device is in range of the length of K171694. Thus, the subject device is substantial | ||||
| equivalent. |
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 Angled | |||
| Abutment | MU Angled Abutment | s-Clean TiN Half Coating | ||
| Angled 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 is | ||||
| explained with Reference Device, K71694 that has same TiN coating and the length of the subject | ||||
| device 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 and | ||
| material. The diameter and length are different but this difference is not important factor to | |||
| the 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 and | |
| material. The diameter and length are different but this difference is not important factor to | ||
| the 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 and | |
| material. The diameter and length are different but this difference is not important factor to | ||
| the 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 and | ||
| material. The length is different but this difference is not important factor to the device | |||
| performance because this device is used temporary. The subject device is substantial | |||
| equivalent. |
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. The | |
| diameter and length are different but this difference is not important factor to the device | ||
| performance. 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.