(143 days)
Dentis s-Clean s-Line Mini is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures. This system is intended for delayed loading.
Dentis s-Clean s-Line Mini is composed of Fixture and Abutments. s-Clean SO-SL Fixture Mini is a thread type implant made of Pure titanium according to ASTM F67 which will be placed in the alveolar bone to replace the function of the missing tooth. This device has connection between the upper prosthesis and the internal Hex. The subject implant body has a two screw-joint (structured with Upper and Lower screw joints) and a hex anti-rotation design connection. The two-screw-joint feature is for diverse screw connection with other abutment that has 1.6M screw or 2.0M Screw. The surface of fixture is treated with SLA (Sandblasted with Large-grit and Acid-etching). It is only part to be implanted into bone, and to provide connection of prosthetic devices or other components of a dental implant set with human body (mandibular or maxillary bone). The system includes various abutments (Cover Screw, Healing Abutment, Sole Abutment, TiN Half Coating Sole Abutment, Couple Abutment, TiN Half Coating Couple Abutment, Angled Abutment, TiN Half Coating Angled Abutment, Abutment Screw, Temporary Abutment, MU Straight Abutment, MU Angled Abutment, MU Angled Abutment Screw) made from Pure titanium (ASTM F67), Ti-6Al-4V (ASTM F136), or PEEK material. Some abutments have Anodizing (Gold Color) or TiN-Coating surface treatments.
This document (K210080) describes the Dentis s-Clean s-Line Mini, an endosseous dental implant system, and its substantial equivalence to predicate devices, rather than an AI/ML-driven device requiring a study to prove meeting acceptance criteria in the context of diagnostic performance (e.g., sensitivity, specificity, AUC).
The acceptance criteria described in this document are related to the physical, chemical, and mechanical properties, as well as the sterility and biocompatibility of the dental implant components, and their substantial equivalence to already marketed devices. The "study" proving acceptance is a series of non-clinical tests and comparisons to predicate devices.
Therefore, I cannot provide a table with "acceptance criteria and reported device performance" as typically found for AI/ML diagnostic devices (e.g., sensitivity, specificity). Instead, I will describe the non-clinical tests and their outcomes as presented in the document to demonstrate the device meets its acceptance criteria for safety and effectiveness as a physical medical device.
1. Table of Acceptance Criteria (for a physical dental implant) and Reported Device Performance
Since this is a physical dental implant, the "acceptance criteria" are based on meeting established standards and demonstrating substantial equivalence to predicate devices in terms of material, design, performance, and biocompatibility.
| Acceptance Criteria Category | Specific Criteria (as implied by tests/comparisons) | Reported Device Performance / Method of Proof |
|---|---|---|
| Material Composition | Conformance to ASTM F67 (Pure titanium) and ASTM F136 (Ti-6Al-4V ELI) standards. | Subject device components (fixture, cover screw, healing abutment, temporary abutment) are fabricated from Pure titanium (ASTM F67). Other abutments are fabricated from Ti-6Al-4V ELI (ASTM F136). Temporary abutment also made of PEEK. This demonstrates material compatibility with predicates. |
| Biocompatibility | Meet ISO 10993 standards (e.g., cytotoxicity, sensitization, irritation, genotoxicity, systemic toxicity, implantation). | Biocompatibility testing was performed on predicate devices (K153639, K171027, K150344, K171694) and was leveraged for the subject device because both products are manufactured with the same materials and manufacturing process. Results met ISO 10993 criteria. |
| Sterilization | Effective sterilization and maintenance of sterility. | Fixture sterilization validation (ISO 11137-1,2,3) leveraged from predicate K192688. End User Sterilization Validation Test Report on Abutments (ANSVAAMI ST79, ISO 17665-1, ISO 17665-2, ISO 11737-1, ISO 11737-2, ISO 11138-1) leveraged from predicate K11364. Fixtures provided sterilized; other abutments provided non-sterilized for end-user sterilization. |
| Shelf-Life | Maintain integrity and performance over specified shelf-life. | Shelf-Life Test on fixtures leveraged from predicate K153639 (ASTM F1980), as material, sterilization, packaging, and manufacturing are the same. |
| Bacterial Endotoxin | Meet endotoxin limits for medical devices. | Bacterial Endotoxin Test Report on fixtures leveraged from predicate K192688 (ANSVAAMI ST72:2011, USP <161>, USP <85>). |
| Mechanical Performance (Fatigue) | Withstand cyclic loading without failure, demonstrating structural integrity comparable to or better than predicates. | Fatigue Testing under worst-case scenario (ISO 14801:2016) was performed on the subject device. A comparative fatigue test between single-screw and dual-screw joint implants showed that the device performance was substantially equivalent. |
| Surface Characteristics | Comparable surface treatment properties to predicates. | Fixture surface treated with SLA (Sandblasted with Large-grit and Acid-etching). Surface roughness, surface composition analysis, and SEM imaging were provided (compared to K153639) to demonstrate substantial equivalence. |
| Dimensional Tolerance | Dimensions within acceptable manufacturing tolerances. | Reported tolerance of dimension for fixtures and abutments is within ± 1% range. This is a manufacturing acceptance criterion rather than a test result. |
| Indications for Use | Aligned with predicate devices for safe and effective use. | Identical indications for use as the primary predicate device (K153639), including use in partially/fully edentulous mandibles/maxillae, support for single/multiple unit restorations (cemented, screw-retained, overdenture, fixed bridgework), one/two-stage surgical procedures, and delayed loading. |
| Design Characteristics | Overall design comparable and functionally equivalent to predicates. | Detailed comparison tables are provided for each component (fixture, cover screw, various abutments, screws) against multiple predicate/reference devices, highlighting similarities in design, diameter, length, angulation (where applicable), coating, and material. Any differences are explained and justified by comparison to other referenced devices. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: The document doesn't specify a "test set" in the context of an AI/ML diagnostic algorithm. For the physical device, fatigue testing per ISO 14801 would involve a specific number of samples, but the exact count is not provided. Other tests like biocompatibility, sterilization, and shelf-life are typically performed on a limited number of samples representative of the product. The document states a comparative fatigue test was conducted.
- Data Provenance: Not applicable in the context of AI/ML. The "data" here refers to the results of non-clinical bench testing and material characterization. The manufacturer is Dentis Co., Ltd. from South Korea. The testing was performed according to international standards (ISO, ASTM, USP) and FDA-recognized guidance. It's a "prospective" assessment in that the tests were done on the manufactured devices to demonstrate their properties.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This is not applicable for a physical medical device submission like this one. "Ground truth" in this context refers to established standards (e.g., ISO for fatigue, ASTM for materials, ISO/AAMI for sterilization), which are derived from broad expert consensus in relevant fields (engineering, microbiology, toxicology, dentistry).
4. Adjudication Method for the Test Set:
- Not applicable as this is not an AI/ML diagnostic study with human readers. Test results are compared against defined standard criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, this type of study is not relevant for a physical dental implant. MRMC studies are typically for evaluating the diagnostic performance of AI/ML systems, often with human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. There is no algorithm or AI component in this dental implant.
7. The Type of Ground Truth Used:
- The "ground truth" for proving the device's acceptance is based on:
- International Standards: Conformance to recognized standards such as ISO 14801 (fatigue), ISO 10993 series (biocompatibility), ISO 11137 series (sterilization), ASTM F67, F136, F1980 (materials, shelf-life), and AAMI/USP guidelines for bacterial endotoxins.
- Predicate Device Comparison: Substantial equivalence is established by demonstrating that the subject device has the "same intended use and fundamental scientific technology" as legally marketed predicate devices, and any differences "do not raise different questions of safety and effectiveness."
8. The Sample Size for the Training Set:
- Not applicable. There is no AI/ML training set for this physical device.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. There is no AI/ML training set.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Dentis Co., Ltd. % April Lee Consultant Withus Group Inc 106 Superior Irvine, California 92620
Re: K210080
Trade/Device Name: Dentis s-Clean s-Line Mini Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: May 3, 2021 Received: May 6, 2021
Dear April Lee:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210080
Device Name Dentis s-Clean s-Line Mini
Indications for Use (Describe)
Dentis s-Clean s-Line Mini is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures. This system is intended for delayed loading.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CER 801 Subpart D) | □ Over-The-Counter Use (21 CER 801 Subpart C) |
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510(K) Summary
Submitter
Dentis Co., Ltd. Gyu Ri Kim 99, Seongseoseo-ro, Dalseo-gu Daegu, 42718 Korea Email: kgr1026@dentis.co.kr Tel. +82-53-589-3541 Fax. +82-53-289-7922
Device Information
- Trade Name: Dentis s-Clean s-Line Mini ●
- Common Name: Dental Implant System
- Classification Name: Endosseous dental implant ●
- Product Code: DZE
- Secondary Product Code: NHA ●
- Panel: Dental
- Regulation Number: 872.3640
- Device Class: Class II
- Date Prepared: 06/04/2021
Predicate Devices:
Primary Predicate
- K153639, Dentis Dental Implant System manufactured by Dentis Co., Ltd. ●
Reference devices
- K123155, Luna Dental Implant System manufactured by SHINHUNG MST Co., Ltd. ●
- K123988. AnyOne Internal Implant System by MegaGen implant Co., Ltd
- K150344, Dentis Dental Implant System manufactured by Dentis Co., Ltd.
- K161689, OSSTEM Implant System - Abutment by OSSTEM Implant Co., Ltd
- K171027, Dentis Dental Implant System manufactured by Dentis Co., Ltd. ●
- K171694, s-Clean TiN Coating Abutment manufactured by Dentis Co., Ltd.
- K192436, Healing Abutments and Cover Screws manufactured by Dentium Co., Ltd.
- K200099, s-Clean SQ-SL Implant System Mini manufactured by Dentis Co., Ltd. ●
- K202773. s-Clean SO-SL Implant System Mini manufactured by Dentis Co., Ltd. ●
Indication for Use:
Dentis s-Clean s-Line Mini is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures. This system is intended for delayed loading.
Withus Group Inc. April Lee 106 Superior, Irvine, CA 92620 USA Email: withus6664@gmail.com Phone: 1-909-274-9971 Fax: 1-909-460-8122
Official Correspondent
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Device Description:
Dentis s-Clean s-Line Mini is composed of Fixture and Abutments. s-Clean SO-SL Fixture Mini is a thread type implant made of Pure titanium according to ASTM F67 which will be placed in the alveolar bone to replace the function of the missing tooth. This device has connection between the upper prosthesis and the internal Hex.
The subject implant body has a two screw-joint (structured with Upper and Lower screw joints) and a hex anti-rotation design connection. The two-screw-joint feature is for diverse screw connection with other abutment that has 1.6M screw or 2.0M Screw. s-Clean Sole Abutment s-Line Mini and s-Clean TiN Half Coating Sole Abutment s-Line Mini have Upper M2.0 screw and s-Clean Couple Abutment s-Line Mini, s-Clean TiN Half Coating Couple Abutment s-Line Mini, s-Clean Angled Abutment s-Line Mini and s-Clean TiN Half Coating Angled Abutment s-Line Mini have Lower M1.6 screw. When dividing screw assemble design, screw assembled one-piece abutment is connected with upper screw and screw separated two-piece abutment is connected with lower screw.
The surface of fixture is treated with SLA (Sandblasted with Large-grit and Acid-etching). It is only part to be implanted into bone, and to provide connection of prosthetic devices or other components of a dental implant set with human body (mandibular or maxillary bone).
| No. | Device Name | Dimension Ranges |
|---|---|---|
| 1 | s-Clean SQ-SL Fixture Mini | Ø5.8, 6.8 and 7.8 (D) X 7.5, 9.5, 11.4 and 11.5mm |
The dimensions of fixtures are as following:
Tolerance of dimension shall be within ± 1% range.
| No. | Device Name | Dimension Ranges | Angulation |
|---|---|---|---|
| 1 | s-Clean Cover Screw Mini | Ø3.2 (D) x 5.0mm (L) | 0° |
| 2 | s-Clean Healing Abutment s-LineMini | Ø4.3, 4.8 and 5.8 (D) X 7.61, 8.61, 9.61, 10.61, 11.61,12.61 and 14.61mm (L) | 0° |
| 3 | s-Clean Sole Abutment s-LineMini | Ø4.5 and 5.5 (D) X 11.01, 12.01, 12.51, 13.01, 13.51,14.01, 14.51, 15.01, 15.51, 16.01 and 17.01mm (L) | 0° |
| 4 | s-Clean TiN Half Coating SoleAbutment s-Line Mini | Ø4.5 and 5.5 (D) X 11.01, 12.01, 12.51, 13.01, 13.51,14.01, 14.51, 15.01, 15.51, 16.01 and 17.01mm (L) | 0° |
| 5 | s-Clean Couple Abutment s-LineMini | Ø4.0, 4.5 and 5.5 (D) X 8.35, 8.6, 9.35, 9.6, 9.85, 10.1,10.35, 10.6, 10.85, 11.1, 11.35, 11.6, 11.85, 12.1, 12.35,12.6, 12.85, 13.1, 13.35, 13.6, 14.35 and 14.6mm (L) | 0° |
| 6 | s-Clean TiN Half Coating CoupleAbutment s-Line Mini | Ø4.0, 4.5 and 5.5 (D) X 8.35, 8.6, 9.35, 9.6, 9.85, 10.1,10.35, 10.6, 10.85, 11.1, 11.35, 11.6, 11.85, 12.1, 12.35,12.6, 12.85, 13.1, 13.35, 13.6, 14.35 and 14.6mm (L) | 0° |
| 7 | s-Clean Angled Abutment s-LineMini | Ø4.0, 4.5 and 5.5 (D) X 12.09, 12.34, 12.51, 12.76,13.09, 13.34, 13.51 and 13.76mm (L) | 15° and 25° |
| 8 | s-Clean TiN Half Coating AngledAbutment s-Line Mini | Ø4.0, 4.5 and 5.5 (D) X 12.09, 12.34, 12.51, 12.76,13.09, 13.34, 13.51 and 13.76mm (L) | 15° and 25° |
| 9 | s-Clean Abutment Screw s-LineMini | Ø2.03 (D) X 10.2mm (L) | 0° |
| 10 | s-Clean Temporary AbutmentMini | Ø4.0, 4.5 and 5.5 (D) X 13.45, 13.7, 15.45 and 15.7mm | 0° |
| 11 | s-Clean MU Straight AbutmentMini | Ø4.8 (D) X 8.71, 9.71, 10.71, 11.71 and 12.71mm (L) | 0° |
The dimensions of abutments are as following:
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| 12 | s-Clean MU Angled AbutmentMini | Ø1.56 (D) X 7.25, 7.74, 8.25, 8.74, 9.25, 9.74, 10.25and 10.74mm (L) | 17° and 30° |
|---|---|---|---|
| 13 | s-Clean MU Angled AbutmentScrew Mini | Ø1.56 (D) X 9.3mm (L) | 0° |
The Abutments have below featured:
| Name | Uses | Surface | Connection |
|---|---|---|---|
| s-Clean Cover Screw Mini | It is used for protecting inner hole andconnecting part with exposed upper partof structure during the healing period afterinserting dental implant fixture | Anodizing(Gold Color) | ScrewRetained |
| s-Clean Healing Abutments-Line Mini | The healing Abutment is used forprotecting inner hole of fixture andadjusting the appropriate height during thehealing period | Anodizing(Gold Color) | ScrewRetained |
| s-Clean Sole Abutment s-Line Mini | N/A | ||
| s-Clean TiN Half Coating SoleAbutment s-Line Mini | The Abutment is connected with fixture | TiN-Coating | Internal Hex |
| s-Clean Couple Abutment s-Line Mini | The Abutment is connected with fixtureand it supports prosthesis which restorestooth function. | N/A | |
| s-Clean TiN Half Coating CoupleAbutment s-Line Mini | The Abutment is connected with fixture | TiN-Coating | Internal Hex |
| s-Clean Angled Abutment s-LineMini | The Abutment is connected with fixtureand it supports prosthesis which restorestooth function | N/A | |
| s-Clean TiN Half Coating AngledAbutment s-Line Mini | TiN-Coating | Internal Hex | |
| s-Clean Abutment Screw s-Line Mini | This screw is used for connect fixture andabutment | N/A | ScrewRetained |
| s-Clean Temporary Abutment Mini | This Abutment is used for prostheticrestore temporary | N/A | Internal Hex |
| s-Clean MU Straight Abutment Mini | MU Abutment is useful for various | TiN-Coating | Internal Hex |
| s-Clean MU Angled Abutment Mini | angulation implanted fixture and gingivalangulation. | TiN-Coating | Internal Hex |
| s-Clean MU Angled Abutment ScrewMini | This Screw is used for fixture and MUAngled Abutment | N/A | ScrewRetained |
Tolerance of dimension for Abutments shall be within ± 1% range.
The multi-unit abutments are only intended to be used in multi-unit restorations.
The purpose of Anodizing for s-Clean Cover Screw Mini and s-Clean Healing Abutment s-Line Mini is to distinguish the sizes with the naked eyes for convenience.
s-Clean SQ-SL Fixture Mini, s-Clean Cover Screw Mini and s-Clean Healing Abutment s-Line Mini are provided sterilized. And the other Abutments are provided non-sterilized.
s-Clean SO-SL Fixture Mini is enclosed with s-Clean Cover Screw Mini in a set packing. s-Clean Cover Screw Mini is also provided separately.
Materials:
- s-Clean SQ-SL Fixture Mini, s-Clean Cover Screw Mini, s-Clean Healing Abutment s-Line Mini and ● s-Clean Temporary Abutment Mini are fabricated from Pure titanium of ASTM F67
- The s-Clean (TiN Half Coating) Sole Abutment s-Line Mini, s-Clean (TiN Half Coating) Couple ● Abutment s-Line Mini, s-Clean (TiN Half Coating) Angled Abutment s-Line Mini, s-Clean Abutment Screw s-Line Mini, s-Clean MU Straight Abutment Mini, s-Clean MU Angled Abutment Mini and s-Clean MU Angled Abutment Screw Mini are fabricated from Ti-6Al-4V of ASTM F136
- The s-Clean Temporary Abutment Mini is fabricated from PEEK material. ●
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Summaries of Technological Characteristics & Substantial Equivalence Discussion
| s-Clean SO-SL Fixture Mini | |
|---|---|
| ---------------------------- | -- |
| Subject Device | Predicate Device | Reference Device | ||
|---|---|---|---|---|
| K number | NA | K153639 | K202773 | |
| Manufacturer | Dentis Co., Ltd | Dentis Co., Ltd | Dentis Co., Ltd. | |
| Trade Name | Dentis s-Clean s-LineMini | Dentis Dental ImplantSystem | s-Clean SQ-SL Implant SystemMini | |
| Design | Image: Dentis s-Clean s-Line Mini | Image: Dentis Dental Implant System | Image: s-Clean SQ-SL Implant System Mini | |
| Indications forUse | Dentis s-Clean s-LineMini is indicated for usein partially or fullyedentulous mandibles andmaxillae, in support ofsingle or multiple unitrestorations including;cemented retained, screwretained, or overdenturerestorations, and terminalor intermediate abutmentsupport for fixedbridgework. This systemis dedicated for one andtwo stage surgicalprocedures. This system isintended for delayedloading. | The OneQ-SL s-CleanImplant System isindicated for use inpartially or fullyedentulous mandibles andmaxillae, in support ofsingle or multiple unitrestorations including;cemented retained, screwretained, or overdenturerestorations, and terminalor intermediate abutmentsupport for fixedbridgework. This system isdedicated for one and twostage surgical proceduresand not dedicated forimmediate loading. Thissystem is intended fordelayed loading | s-Clean SQ-SL Implant SystemMini is indicated for use inpartially or fully edentulousmandibles and maxillae, insupport of single or multiple unitrestorations including; cementedretained, screw retained, oroverdenture restorations, andterminal or intermediateabutment support for fixedbridgework. This system isdedicated for one and two stagesurgical procedures.This system is intended fordelayed loading. | |
| Diameter | Ø5.8, 6.8 and 7.8 | Ø3.7, 3.9, 4.2, 4.7, 5.2, 6.0,7.0 and 8.0 | Ø3.7, 4.1 | |
| Length | 7.5, 9.5, 11.4, 11.5mm | 7, 8, 10, 12, 14mm | 7.5, 9.5, 11.5, 13.5mm | |
| SurfaceTreatment | SLA | SLA | SLA | |
| Material | CP Titanium Gr4 (ASTMF67) | CP Titanium Gr4 (ASTMF67) | CP Titanium Grade4 (ASTMF67) | |
| Sterilization | Gamma Irradiation | Gamma Irradiation | Gamma Irradiation | |
| Comparison | The Subject Device and primary predicate have same characteristics such as indications forUse, design, diameter, length, surface treatment, material, abutment connection, andsterilization.The difference between subject and primary predicate is only design of screw joint betweenfixture and abutment. Subject device has two screw-joint of fixture and abutment but primarypredicate has only one screw-joint of fixture and abutment. This difference is mitigatedthrough our own device, K202773. Any differences in technology characteristics areaccompanied by information that demonstrated the device is substantially equivalent as thepredicate and do not raise different questions of safety and effectiveness than the predicate. |
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s-Clean Cover Screw Mini
| Subject Device | Reference Device | Reference Device | |
|---|---|---|---|
| K number | NA | K200099 | K192436 |
| Manufacturer | Dentis Co., Ltd | Dentis Co., Ltd | Dentium Co., Ltd |
| Trade Name | Dentis s-Clean s-Line Mini | s-Clean SQ-SL Implant System Mini | Healing Abutments and Cover Screws |
| Model | s-Clean Cover screw Mini | s-Clean Mini Fixture Cover screw | Cover screw |
| Design | Image: Subject Device Design | Image: Reference Device K200099 Design | Image: Reference Device K192436 Design |
| Diameter | $Ø$ 3.2 | $Ø$ 3.1 | $Ø$ 3.10, 3.18, 3.37, 3.50, 3.55, 4.12 and 4.30 |
| Length | 5.0mm | 5.4mm | 4.70, 5.40, 5.70, 5.75, 6.35, 6.36, 6.88 and 8.92mm |
| Coating | Anodizing (Gold Color) | Non | Anodizing (Black, Blue, Green Color) / Non |
| Material | Titanium Gr4 (ASTM F67) | Titanium Gr4 (ASTM F67) | Ti-6Al-4V ELI (ASTM F136) |
| Sterilization | Sterile | Sterile | Sterile |
| Comparison | Subject Device and Reference Device, K200099 have same indications and material. The diameter and length are different from K200099, but this difference is not important factor to the device performance. Subject device is anodized to make a division according to device size. To support the surface coating and dimension differences from K200099, K192436 is added as the reference device. Therefore, the subject device is substantial equivalent. |
s-Clean Healing Abutment s-Line Mini
| Subject Device | Reference Device | Reference Device | |
|---|---|---|---|
| K number | NA | K171027 | K123155 |
| Manufacturer | Dentis Co., Ltd | Dentis Co., Ltd | SHINHUNG MST CO.,Ltd |
| Trade Name | Dentis s-Clean s-Line Mini | Dentis Dental Implant System | Luna Dental ImplantSystem |
| Model | s-Clean Healing Abutment s-Line Mini | Healing Abutment | Healing Abutment |
| Design | Image: Subject Device Design | Image: Reference Device K171027 Design | Image: Reference Device K123155 Design |
| Diameter | Ø4.3, 4.8 and 5.8 | Ø4.0, 4.5, 4.8, 5.0, 5.5, 6.0, 6.5,7.0 and 7.5 | Ø4.5~7.0 |
| Length | 7.61, 8.61, 9.61, 10.61, 11.61,12.61 and 14.61mm | 9.5, 10.0, 10.5, 11.0, 11.5, 12.0,12.5, 13.0, 13.5 and 14.0mm | 2.0, 3.5, 5.0 and 7.0 |
| Coating | Anodizing (Gold Color) | Non | Anodizing(Purple, Blue Color) |
| Material | Titanium Gr4 (ASTM F67) | Titanium Gr4 (ASTM F67) | Titanium Gr4 (ASTM F67) |
| Sterilization | Sterile | Sterile | Sterile |
| Comparison | Subject Device and reference device, K171027 have same Indications and material. The diameterand length are different from K171027 but this difference is not important factor to the deviceperformance. Subject device is anodized to make a division according to device size. Thisdifference about surface coating is explained through Reference Device, K123155. Therefore, thesubject 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-LineMini | s-Clean TiN Coating Abutment | Dentis Dental ImplantSystem |
| Model | s-Clean SoleAbutment s-Line Mini& s-Clean TiN HalfCoating SoleAbutment s-Line Mini | s-Clean TiN Partial Coating SoleAbutment | Sole Abutment |
| Design | Image: Design of subject device | Image: Design of reference device K171694 | Image: Design of reference device K171027 |
| Diameter | Ø4.5 and 5.5 | Ø4.5, 4.8, 5.5, 6.0 and 6.5 | Ø4.5, 4.8, 5.5, 6.0 and6.5 |
| Gingival Height | 1.8, 2.8, 3.8, 4.8 | 0.8, 1.3, 1.8, 2.3, 3.3, 4.3 and 5.3 | 0.8, 1.3, 1.8, 2.3, 3.3,4.3, and 5.3 |
| Length | 11.01, 12.01, 12.51,13.01, 13.51, 14.01,14.51, 15.01, 15.51,16.01 and 17.01mm | 10.6, 11.0, 11.5, 11.6, 12.0, 12.1,12.5, 13.0, 13.1, 13.5, 13.6, 14.0,14.1, 14.5, 15.0, 15.1, 15.5, 16.0,16.1, 16.5, 16.6, 17.0, 17.1, 17.5,18.1 and 18.5mm | 12.5, 13.0, 13.5, 14.0,15.0, 16.0 and 17.0mm |
| Coating | Non & TiN Coating | TiN Coating | Non |
| Material | Ti-6Al-4V ELI(ASTM F136) | Ti-6Al-4V ELI(ASTM F136) | Ti-6Al-4V ELI(ASTM F136) |
| Sterilization | End User Sterilization | End User Sterilization | End User Sterilization |
| Comparison | Subject Device and Reference Devices, K171694 and K171027 have same diameter,length, material and sterilization method. The subject device has two types of 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 issubstantial equivalent. |
s-Clean Sole Abutment s-Line Mini & s-Clean TiN Half Coating Sole Abutment s-Line Mini
s-Clean Couple Abutment s-Line Mini & s-Clean TiN Half Coating Couple Abutment s-Line Mini
| Subject Device | Reference Device | Reference Device | ||||
|---|---|---|---|---|---|---|
| K number | NA | K171694 | K171027 | |||
| Manufacturer | Dentis Co., Ltd | Dentis Co., Ltd | Dentis Co., Ltd | |||
| Trade Name | Dentis s-Clean s-Line Mini | s-Clean TiN CoatingAbutment | Dentis Dental Implant System | |||
| Model | s-Clean Couple Abutments-Line Mini & s-Clean TiNHalf Coating CoupleAbutment s-Line Mini | s-Clean TiN Half CoatingCouple Abutment | Couple Abutment | |||
| Design | Image: Subject Device Design | Image: Reference Device K171694 Design | Image: Reference Device K171027 Design | |||
| Diameter | Ø4.0, 4.5 and 5.5 | Ø4.5, 4.8, 5.5, 6.0 and Ø6.5 | Ø4.0, 4.5, 4.8, 5.5, 6.0 and Ø6.5 | |||
| Gingival Height | 1.8, 2.8, 3.8, 4.8 | 0.8, 1.3, 1.8, 2.3, 3.3, 4.3and 5.3mm | 0.8, 1.3, 1.8, 2.3, 3.3, 4.3 and5.3mm | |||
| Length | 8.35, 8.6, 9.35, 9.6, 9.85,10.1, 10.35, 10.6, 10.85,11.1, 11.35, 11.6, 11.85,12.1, 12.35, 12.6, 12.85, | 7.3, 7.44, 7.8, 7.94, 8.3,8.44, 8.8, 8.94, 9.3, 9.44,9.8, 9.94, 10.3, 10.44, 10.8,10.94, 11.3, 11.44, 11.8, | 7.3, 7.44, 7.8, 7.94, 8.3, 8.44,8.8, 8.94, 9.3, 9.44, 9.8, 9.94,10.3, 10.4, 10.44, 10.8, 10.9,10.94, 11.3, 11.4, 11.44, 11.8, |
{9}------------------------------------------------
| 13.1, 13.35, 13.6, 14.35,14.6 | 11.94, 12.3, 12.44, 12.8,12.94, 13.3, 13.44, 13.8,13.94, 14.8 and 14.94mm | 11.9, 11.94, 12.3, 12.44, 12.8,12.9, 12.94, 13.3, 13.44, 13.8,13.9, 13.94, 14.8, 14.9 and14.94mm | |
|---|---|---|---|
| Coating | Non | TiN Coating | Non |
| Material | Ti-6Al-4V ELI(ASTM F136) | Ti-6Al-4V ELI(ASTM F136) | Ti-6Al-4V ELI(ASTM F136) |
| Sterilization | End User Sterilization | End User Sterilization | End User Sterilization |
| Comparison | Subject Device and Reference Devices, K171694 and K171027 have same diameter, length,material and sterilization method. The subject device has two types of surface coating, non-coating and TiN coating. K171027 is selected for non-coating abutment and K171694 isselected for TiN coating abutment as predicates. The subject device is substantial equivalent. |
s-Clean Angled Abutment s-Line Mini & s-Clean TiN Half Coating Angled Abutment s-Line Mini
| Subject Device | Reference Device | Reference Device | |
|---|---|---|---|
| K number | NA | K171694 | K123988 |
| Manufacturer | Dentis Co., Ltd | Dentis Co., Ltd | MegaGemImpalnt Co., Ltd |
| Trade Name | Dentis s-Clean s-Line Mini | s-Clean TiN Coating Abutment | AnuOne Imternal Implant System |
| Model | s-Clean Angled Abutment s-Line Mini & s-Clean TiN Half Coating Angled Abutment s-Line Mini | s-Clean TiN Half Coating Angled Abutment | Angld Abutment |
| Design | Image: s-Clean Angled Abutment s-Line Mini & s-Clean TiN Half Coating Angled Abutment s-Line Mini | Image: s-Clean TiN Half Coating Angled Abutment | Image: Angld Abutment |
| Diameter | Ø4.0, 4.5 and 5.5 | Ø4.5, 5.0,5.5 and Ø6.5 | Ø3.8~10.0 |
| GingivalHeight | 2.8 and 3.8 | 0.8, 1.8 and 3.8mm | 2.5 and 4.5mm |
| Length | 12.09, 12.34, 12.51, 12.76, 13.09,13.34, 13.51, 13.76, | 10.18, 10.4, 10.46, 10.6,11.18, 11.6, 12.4, 13.18 and13.6 | 7.7~18.7 |
| Angulation | 15° and 25° | 15° and 25° | 15° and 25° |
| Coating | Non | TiN Coating | TiN Coating |
| Material | Ti-6Al-4V ELI(ASTM F136) | Ti-6Al-4V ELI(ASTM F136) | Ti-6Al-4V ELI(ASTM F136) |
| Sterilization | End User Sterilization | End User Sterilization | End User Sterilization |
| Comparison | Subject Device and Reference Devices, K171694 and K171027 have same diameter, length,material, angulation and sterilization method. The subject device has two types of 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. |
{10}------------------------------------------------
s-Clean Abutment Screw s-Line Mini
| Subject Device | Reference Device | |
|---|---|---|
| K number | NA | K171027 |
| Manufacturer | Dentis Co., Ltd | Dentis Co., Ltd |
| Trade Name | Dentis s-Clean s-Line Mini | s-Clean TiN Coating Abutment |
| Model | s-Clean Abutment Screw s-Line Mini | Abutment Screw |
| Design | Image: Subject Device Design | Image: Reference Device Design |
| Head Diameter | $Ø$ 2.03 | $Ø$ 2.32 |
| Length | 10.2mm | 8.8, 9.8, 9.95 and 10.5mm |
| Coating | Non | Non |
| Material | Ti-6Al-4V ELI (ASTM F136) | Ti-6Al-4V ELI (ASTM F136) |
| Sterilization | End User Sterilization | End User Sterilization |
| Comparison | Subject Device and Reference Device, K171694 have same material and applications andsimilar dimensions. The diameter is different but this difference is not important factor tothe device performance. Therefore, the subject device is substantial equivalent. |
s-Clean Temporary Abutment Mini
| Subject Device | Reference Device | Reference Device | |
|---|---|---|---|
| K number | NA | K171027 | K161689 |
| Manufacturer | Dentis Co., Ltd | Dentis Co., Ltd | OSSTEM Implant Co., Ltd |
| Trade Name | Dentis s-Clean s-Line Mini | Dentis Dental Implant System | OSSTEM Implant System - Abutment |
| Model | s-Clean Temporary Abutment Mini | Temporary Abutment | Quick Temporary Abutment |
| Design | Image: Design of s-Clean Temporary Abutment Mini | Image: Design of Temporary Abutment | Image: Design of Quick Temporary Abutment |
| Diameter | $Ø$ 4.0, 4.5, and 5.5 | $Ø$ 4.5, 4.8, 5.5, 6.0 and 6.5 | $Ø$ 4.0 and 4.5 |
| Length | 13.45, 13.7, 15.45 and 15.7mm | 13.4 and 13.54mm | 11.5mm |
| Coating | Non | Non | Non |
| Material | PEEK | PEEK | PEEK |
| Sterilization | End User Sterilization | End User Sterilization | End User Sterilization |
| Comparison | Subject Device and Reference Device, K171027 have same material and applications and similar dimensions. Difference are lengths but this difference is not important factor for performance because this device is used for temporary and explained through Reference Device, K161689 |
{11}------------------------------------------------
s-Clean Temporary Abutment Mini
| Subject Device | Reference Device | Reference Device | |
|---|---|---|---|
| K number | NA | K171027 | K161689 |
| Manufacturer | Dentis Co., Ltd | Dentis Co., Ltd | OSSTEM Implant Co., Ltd |
| Trade Name | Dentis s-Clean s-Line Mini | Dentis Dental ImplantSystem | OSSTEM Implant System -Abutment |
| Model | s-Clean TemporaryAbutment Mini | Temporary Abutment | Quick Temporary Abutment |
| Design | Image: Design of s-Clean Temporary Abutment Mini | Image: Design of Temporary Abutment | Image: Design of Quick Temporary Abutment |
| Diameter | ⌀4.0, 4.5, and 5.5 | ⌀4.5, 4.8, 5.5, 6.0 and 6.5 | ⌀4.0 and 4.5 |
| Length | 13.45, 13.7, 15.45 and15.7mm | 13.4 and 13.54mm | 13.0, 13.5, 13.6, 15.0, 15.5and 15.6mm |
| Coating | Non | Non | Non |
| Material | CP Titanium Gr4(ASTM F67) | CP Titanium Gr4(ASTM F67) | Ti-6Al-4V ELI(ASTM F136) |
| Sterilization | End User Sterilization | End User Sterilization | End User Sterilization |
| Comparison | Subject Device and Reference Device, K171027 have same material and applications andsimilar dimensions. Difference are diameter but this difference is not important factor forperformance because this device is used for temporary and explained through ReferenceDevice. K161689. |
s-Clean MU Straight Abutment Mini
| Subject Device | Reference Device | Reference Device | ||
|---|---|---|---|---|
| K number | NA | K150344 | K171694 | |
| Manufacturer | Dentis Co., Ltd | Dentis Co., Ltd | Dentis Co., Ltd | |
| Trade Name | Dentis s-Clean s-LineMini | Dentis Dental ImplantSystem | s-Clean TiN Coating Abutment | |
| Model | s-Clean MU StraightAbutment Mini | MU Solid Abutment | s-Clean TiN Partial Coating SoleAbutment | |
| Design | Image: s-Clean MU Straight Abutment Mini | Image: MU Solid Abutment | Image: s-Clean TiN Partial Coating Sole Abutment | |
| Diameter | $Ø4.8$ | $Ø4.8$ | $Ø4.5$ , 4.8, 5.5, 6.0 and 6.5 | |
| Length | 8.71, 9.71, 10.71, 11.71and 12.71mm | 4.34, 5.34, 6.08, 6.34, 6.69,7.34, 8.08, 8.69, 9.2, 10.2,11.2 and 12.2mm | 10.6, 11.0, 11.5, 11.6, 12.0, 12.1,12.5, 13.0, 13.1, 13.5, 13.6, 14.0,14.1, 14.5, 15.0, 15.1, 15.5, 16.0,16.1, 16.5, 16.6, 17.0, 17.1, 17.5,18.1 and 18.5mm | |
| Coating | TiN Coating | Non | TiN Coating | |
| Material | Ti-6Al-4V ELI(ASTM F136) | Ti-6Al-4V ELI(ASTM F136) | Ti-6Al-4V ELI(ASTM F136) | |
| Sterilization | End User Sterilization | End User Sterilization | End User Sterilization | |
| Comparison | Subject Device and Reference Device, K150344 have same material, diameter andapplications. Differences between subject device and reference device is surface coating andlengths. To support this discrepancy, K171694 is added. The length difference doesn't affectproduct performance because the subject device's lengths are in range of the predicate's.Therefore, the subject device is substantial equivalent. |
{12}------------------------------------------------
| Subject Device | Reference Device | Reference Device | ||
|---|---|---|---|---|
| K number | NA | K150344 | K171694 | |
| Manufacturer | Dentis Co., Ltd | Dentis Co., Ltd | Dentis Co., Ltd | |
| Trade Name | Dentis s-Clean s-LineMini | Dentis Dental ImplantSystemMulti-unit Abutments | s-Clean TiN Coating Abutment | |
| Model | s-Clean MU AngledAbutment Mini | MU Angled Abutment | s-Clean TiN Half Coating AngledAbutment | |
| Design | Image: s-Clean MU Angled Abutment Mini | Image: MU Angled Abutment | Image: s-Clean TiN Half Coating Angled Abutment | |
| Diameter | Ø4.8 | Ø4.8 | Ø4.5, 5.0,5.5 and Ø 6.5 | |
| Length | 7.25, 7.74, 8.25, 8.74,9.25, 9.74, 10.25 and10.74mm | 4.34, 5.34, 6.08, 6.34, 6.69,7.34, 8.08, 8.69, 9.2, 10.2,11.2 and 12.2mm | 10.18, 10.4, 10.46, 10.6, 11.18,11.6, 12.4, 13.18 and 13.6 | |
| Angulation | 17° and 30 ° | 17° and 30 ° | 15° and 25° | |
| Coating | TiN Coating | Non | TiN Coating | |
| Material | Ti-6Al-4V ELI(ASTM F136) | Ti-6Al-4V ELI(ASTM F136) | Ti-6Al-4V ELI(ASTM F136) | |
| Sterilization | End User Sterilization | End User Sterilization | End User Sterilization | |
| Comparison | Subject Device and Reference Device, K150344 have same indications, material, diameter,angulation, and sterilization method. Differences between subject device and reference deviceis surface coating and lengths. To support this discrepancy, K171694 is added. The lengthdifference doesn't affect product performance because the subject device's lengths are in rangeof the predicate's. Therefore, the subject device is substantial equivalent. |
s-Clean MU Angled Abutment Mini
s-Clean MU Angled Abutment Screw Mini
| Subject Device | Reference Device | |
|---|---|---|
| K number | NA | K150344 |
| Manufacturer | Dentis Co., Ltd | Dentis Co., Ltd |
| Trade Name | Dentis s-Clean s-Line Mini | Dentis Dental Implant System |
| Model | s-Clean MU Angled Abutment Screw Mini | MU Abutment Screw |
| Design | Image: Subject Device Design | Image: Reference Device Design 1, Image: Reference Device Design 2 |
| Head Diameter | $Ø$ 1.56 | $Ø$ 1.96 and 2.32 |
| Length | 9.3 | 7.8, 9.2, 10.2, 11.2 and 12.2mm |
| Material | Ti-6Al-4V ELI (ASTM F136) | Ti-6Al-4V ELI (ASTM F136) |
| Sterilization | End User Sterilization | End User Sterilization |
| Comparison | Subject Device and Reference Device, K150344 have same indications and material and similar dimensions. The diameter and length is different but this difference is not important factor to the device performance. Therefore, the subject device is substantial equivalent. |
{13}------------------------------------------------
Non-Clinical Test Data
Below tests were performed on subject device:
-
Fatigue Testing under the worst-case scenario according to ISO 14801:2016 .
Below tests were performed for predicate devices and leveraged for the subject device: -
Sterilization Validation Test on Fixtures according to ISO 11137-1.2,3 referenced in K192688 ●
-
End User Sterilization Validation Test Reort on Abutments according to ANSVAAMI ST79. ● ISO 17665-1, ISO 17665-2, ISO 11737-1, ISO 11737-2, and ISO 11138-1 referenced in K11364
-
Shelf-Life Test on Fixtures according to ASTM F1980 referenced in K153639
-
Biocompatibility testing on fixtures according to ISO 10993-1:2009. ISO 10993-3:2014. ISO ● 10993-5:2009, ISO 10993-6:2007, ISO 10993-10:2010 and ISO 10993-11:2006 referenced in K153639
-
. Biocompatibility testing on Abutments made with Ti-6Al-4V ELI according to ISO 10993-1:2009, ISO 10993-3:2014, ISO 10993-5:2009, ISO 10993-6:2007, ISO 10993-10:2010 and ISO 10993-11:2006 referenced in K171027 and K150344
-
Biocompatibility testing on TiN Coating Abutments according to ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-10:2010 and ISO 10993-11:2006 referenced in K171694
-
Biocompatibility evaluation on abutments made with PEEK referenced in K171027
-
Bacterial Endotoxin Test Report on Fixtures according to ANSVAAMI ST72:2011, USP <161>, and USP <85> referenced in K192688
The results of the above tests have met the criteria of the standards, and demonstrated the substantial equivalence with the predicate device.
The surface modification information with SLA (Sandblasted with Large-grit and Acid-etching) for fixtures was provided. To compare surface modification between the subject and predicate devices, K153639, surface roughness, surface composition analysis, and SEM imaging were provided and it demonstrate the substantial equivalence.
The Sterilization validation test and shelf-life test for fixtures were performed for predicate device, K192688 and K153639 and leveraged for the subject device the material, sterilization method, packaging methods, and manufacturing process of the both products are exactly same.
The end user sterilization test was performed for predicate device, K111364 and leveraged for the subject device because the product category, material, manufacturing process, facility, and packaging of the both products are exactly same.
The Biocompatibility Test was conducted on the predicate device and leveraged for the subject device because both products are manufactured with same materials and manufacturing process.
The fatigue testing per ISO 14801 was conducted under the worst-case scenario. To demonstrate the substantial equivalence of the device performance between single screw joint implant and dual screw joint implant, two fatigue tests were performed comparatively, and result say that device performance was substantial equivalent.
The non-clinical testing results demonstrate that the subject device is substantially equivalent to the predicate device.
Conclusion
Dentis s-Clean s-Line Mini constitutes a substantially equivalent medical device, meeting all the declared requirements of its intended use. This system has the same intended use and fundamental scientific technology as its predicate devices. Therefore, Dentis s-Clean s-Line Mini and its predicates are substantially equivalent.
§ 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.