(175 days)
The s-Clean TiN Coating Abutments is an endosseous dental implant that is indicated for surgical placement in the upper and lower jaw arches, to provide a root for single or multiple-units prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.
The s-Clean TiN Coating Abutments are device made of pure titanium and titanium alloy intended for use as an aid in prosthetic restoration. The system consists of s-Clean TiN Half Coating Angled Abutment, s-Clean TiN Half and partial Coating Couple Abutment, s-Clean TiN Half Coating Free Abutment, s-Clean TiN Half Coating FreeMill Abutment, s-Clean TiN Half Coating MOA Abutment, s-Clean TiN Partial Sub-Octa Abutment, s-Clean TiN Partial Coating Sole Abutment, s-Clean DOA Ball Abutment, s-Clean DOA Snap Abutment, and s-Clean Sole Abutment Healing Cap. The surface of the abutments is partially or half TiN Coated by using PVD (Physical Vapor Deposition). The subject device is provided non-sterile and should be sterilized before use (End user sterilization).
This document is a 510(k) summary for a dental implant abutment, and as such, it focuses on demonstrating substantial equivalence to existing predicate devices rather than proving the device meets acceptance criteria through a standalone clinical study with detailed performance metrics.
Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of submission. The information provided heavily relies on non-clinical testing and comparison to predicates.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here are based on meeting the requirements of specific international and FDA guidance standards for medical devices, particularly for dental abutments. The reported device performance is that these tests were met.
| Acceptance Criteria (Standard / Guidance) | Reported Device Performance |
|---|---|
| Biocompatibility tests according to ISO 10993-1:2009, ISO 10993-3:2014, ISO 10993-5:2009, ISO 10993-10:2010 and ISO 10993-11:2006. | Met the criteria of the standards; device is biocompatible. |
| Fatigue Testing according to ISO 14801:2007 and "Guidance for Industry and Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments". (Worst-case scenario) | Met the criteria of the standards. |
| End User Steam Sterilization Test according to ISO 17665-1:2006, -2:2009 and ANSI/AAMI ST79. (This test was performed for a predicate device K161244 and leveraged for the subject device due to identical product category, material, manufacturing process, facility, and packaging). | Met the criteria for the predicate device, and the results were leveraged for the subject device. |
| Substantial Equivalence to predicate devices (evaluating similarities and differences in design, materials, indications for use). | Demonstrated substantial equivalence. |
2. Sample size used for the test set and the data provenance
- Not Applicable (N/A) for clinical data. This submission relies on non-clinical (laboratory) testing, not a clinical test set with patient data.
- The non-clinical tests (biocompatibility, fatigue, sterilization) are laboratory-based and would use a sample size appropriate for those specific engineering and biological tests, but this detail is not provided. The data provenance for these tests would be internal laboratory testing by the manufacturer or a contracted lab.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A. As mentioned, this is a non-clinical submission. Ground truth, in the context of clinical studies and expert consensus, is not relevant here. Decisions are made based on adherence to engineering and biocompatibility standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- N/A. No clinical test set requiring expert adjudication was conducted or described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- N/A. This is a dental implant abutment, not an AI-powered diagnostic or assistive device. MRMC studies are not relevant here.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- N/A. This is a physical medical device (dental abutment), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the non-clinical tests, the "ground truth" is defined by the validated and accepted international standards (e.g., ISO, ANSI/AAMI) for mechanical performance and biocompatibility. Passing these tests according to the established metrics within the standards constitutes meeting the "ground truth" of safety and performance.
8. The sample size for the training set
- N/A. There is no "training set" as this is not a machine learning or AI product.
9. How the ground truth for the training set was established
- N/A. There is no "training set" as this is not a machine learning or AI product.
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November 29, 2017
Dentis Co., Ltd. % April Lee Consultant Withus Group Inc. 2531 Pepperdale Drive Rowland Heights, California 91748
Re: K171694
Trade/Device Name: s-Clean TiN Coating Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: October 25, 2017 Received: October 31, 2017
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. 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.
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
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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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K171694
Device Name s-Clean TiN Coating Abutments
Indications for Use (Describe)
The s-Clean TiN Coating Abutments is an endosseous dental implant that is indicated for surgical placement in the upper and lower jaw arches, to provide a root for single or multiple-units prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) Summary
Submitter
Dentis Co., Ltd. Sun Chul Shin 99, Seongseoseo-ro, Dalseo-gu Daegu, 42718 South Korea Phone: +82-53-583-2804 Fax: +82-53-583-2806
Device Information
Trade Name: s-Clean TiN Coating Abutments Common Name: Dental Abutment Classification Name: Endosseous Dental Abutment Product Code: NHA Panel: Dental Regulation Number: 872.3630 Device Class: Class II Date Prepared: 11/20/2017
Official Correspondent
Withus Group Inc. April Lee 2531 Pepperdale Drive Rowland Heights, CA 91748 USA Email: withus6664@gmail.com Phone: 909-274-9971 Fax: 909-460-8122
Description
The s-Clean TiN Coating Abutments are device made of pure titanium and titanium alloy intended for use as an aid in prosthetic restoration.
The system consists of s-Clean TiN Half Coating Angled Abutment, s-Clean TiN Half and partial Coating Couple Abutment, s-Clean TiN Half Coating Free Abutment, s-Clean TiN Half Coating FreeMill Abutment, s-Clean TiN Half Coating MOA Abutment, s-Clean TiN Partial Sub-Octa Abutment, s-Clean TiN Partial Coating Sole Abutment, s-Clean DOA Ball Abutment, s-Clean DOA Snap Abutment, and s-Clean Sole Abutment Healing Cap.
The dimension of each abutment ranges as below:
- s-Clean TiN Half Coating Angled Abutment: Ø4.5, 5.0, 5.5 and 6.5 mm (D) x 10.18, 10.46, . 11.04, 11.18, 11.46, 11.6, 13.04, 13.18, 13.46 and 13.6 mm (L) x 15° and 25°
- s-Clean TiN Half and Partial Coating Couple Abutment: Ø4.5, 4.8, 5.5 and 6.5 mm (D) x 0.8, 1.3, ● 1.8, 2.3, 3.3, 4.3 and 5.3mm (Cuff H)
- . s-Clean TiN Half Coating Free Abutment: Ø4.5. 5.5 and 6.5mm (D) x 15.36 and 15.5mm (L)
- s-Clean TiN Half Coating FreeMill Abutment: Ø4.0, 4.5, 5.5, 6.5mm (D) and 7.5mm (D) x 1.3, ● 1.8, 2.8, 3.8 mm (Cuff H)
- . s-Clean TiN Half Coating MOA Abutment: Ø4.5 and 5.5mm(D) x 12.64, 14.14, 14.64, 15.14 and 16.14mm(L)
- s-Clean TiN Partial Sub-Octa Abutment: Ø 4.8 mm (D) x 0.8, 1.3, 2.3, 3.3, 4.3 and 5.3 mm (Cuff ● H)
- . s-Clean TiN Partial Coating Sole Abutment: Ø4.5. 5.5. 6.0 and 6.5 mm (D) x 0.8. 1.3. 1.8. 2.3. 4.3, and 5.3mm (Cuff H)
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- s-Clean DOA Ball Abutment: Ø3.5 mm (D) x 0.6, 1.6, 2.6, 4.6, 5.6 (Cuff H) ●
- s-Clean DOA Snap Abutment: Ø3.5 mm (D) x 3.35 (Cuff H) ●
- s-Clean Sole Abutment Healing Cap: Ø4.6, 5.1, 5.9, 6.3, 6.8 and 6.9mm (D) x 6, 7, 7.5 and 9 mm (L)
The surface of the abutments is partially or half TiN Coated by using PVD (Physical Vapor Deposition).
The subject device is compatible with:
| Compatible Implant names | Implant Models | Sizes |
|---|---|---|
| Dentis Dental Implant System(K171027) | s-Clean Tapered Fixtures-Clean SAVE Fixture | Diameters: Ø3.7, 4.3, 4.8, 5.5, 6.0Length: 7, 8, 10, 12, 14mm |
| Dentis Dental Implant System(K082843) | s-Clean SAVE Fixture | Diameters: Ø6.5, 7.0Lengths:7, 8, 10, 12mm |
| Haptite Coating Implant System(K111364) | HAPTITE s-Clean Tapered FixtureHAPTITE s-Clean Straight FixtureHAPTITE s-Clean SAVE Fixture | Diameters: Ø3.7, 4.1, 4.3, 4.8, 5.5,6.0, 6.5, 7.0Lengths:7, 8, 10, 12, 14mm |
| Dentis Dental Implant System(K150344) | s-Clean Tapered Fixture | Diameters: Ø3.7, 4.1, 4.8Lengths:7, 8, 10, 12, 14mm |
| oneq-sl s-clean implant system(K153639) | OneQ-SL s-Clean Fixture | Diameters: Ø 3.7, 3.9, 4.2, 5.2, 6.0,7.0, 8.0Lengths:7, 8, 10, 12, 14mm |
| s-clean tapered ii rbm implantsystem (K160213) | s-Clean Tapered II RBM Fixture | Diameters: Ø3.7, 4.1, 4.3, 4.8Lengths:7, 8, 9, 10, 12, 14mm |
The subject device is provided non-sterile and should be sterilized before use (End user sterilization).
Indication for Use
The s-Clean TiN Coating Abutments is an endosseous dental implant that is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple-units prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.
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Predicate Device & Comparison
The subject device is substantially equivalent to the following predicate devices:
Primary Predicate
- K171027, Dentis Dental Implant System by Dentis Co., Ltd.
Reference Predicates
- K082843, Dentis Dental Implant System by Dentis Co., Ltd. ●
- K111364, Haptite Coating Implant System by Dentis Co., Ltd. .
- K161244, S-Clean Oneq-sl Narrow Implant System by Dentis Co., Ltd. .
- K153521, IH Prosthetic System by Sewon Medix Inc. .
- K142211, OT Equator by Rhein'83 Srl. .
| Subject device | Primary Predicate | Reference Predicate | Reference Predicate | Reference Predicate | stage surgical processwith an option fortransmucosal healing orthey can be placed in asingle stage surgicalprocess for immediateloading when goodprimary stability has beenachieved and withappropriate occlusalloading. | surgical process with anoption for transmucosalhealing or they can beplaced in a single stagesurgical process forimmediate loading whengood primary stability hasbeen achieved and withappropriate occlusalloading. | two stage surgicalprocedures and not forimmediate load. Also, thissystem is intended to beused in the molar region. | is dedicated for one andtwo stage surgicalprocedures and notdedicated for immediateloading. This system isintended for delayedloading. | bridgework. IH ImplantSystem is for single andtwo stage surgicalprocedures. It is intendedfor delayed loading. | ||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 510(k) number | NA | K171027 | K082843 | K111364 | K153521 | Product Name | s-Clean TiN HalfCoating AngledAbutment | - | Submerged AngledAbutment | - | Angled Abutment |
| Product Name | s-Clean TiN CoatingAbutments | Dentis Dental ImplantSystem | Dentis Dental ImplantSystem | Haptite Coating ImplantSystem | IH Prosthetic System | Dimension | Ø4.5, 5.0, 5.5 and 6.5mm (D) x10.18, 10.6, 10.46,11.04, 11.18, 11.46,11.6, 13.04, 13.18,13.46 and 13.6 mm (L)x 15° and 25° | - | Ø4.5, 5.0, 5.5 and 6.5mm (D) x9, 10.5, 12 mm (L) | - | Ø 4.5/5.0/5.5 /6.0X9.5, 10, 10.5,11, 11.5, 12 (L) |
| Manufacturer | Dentis Co., Ltd. | Dentis Co., Ltd. | Dentis Co., Ltd. | Dentis Co., Ltd. | Sewonmedix Inc. | Material | Ti-6Al-4V ELI(Grade5) | - | Ti-6Al-4V ELI(Grade5) | - | Ti-6Al-4V ELI(Grade5) |
| Indications for Use | The s-Clean TiN CoatingAbutments is anendosseous dental implantthat is indicated forsurgical placement in theupper and lower jawarches, to provide a rootform means for single ormultiple-units prostheticappliance attachment torestore a patient'schewing function.Implants can be placedwith a conventional two | The Dentis Dental ImplantSystem is an endosseousdental implant that isindicated for surgicalplacement in the upperand lower jaw arches, toprovide a root form meansfor single or multiple-units prosthetic applianceattachment to restore apatient's chewingfunction. Implants can beplaced with aconventional two stage | The Dentis Dental ImplantSystem is indicated foruse in 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 and | The HAPTITE CoatingImplant 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 | IH Implant System isdevice made of titaniumand titanium alloyindicated for in partiallyor fully edentulousmandibles and maxillae,in support of single ormultiple-unit restorationsincluding; cementedretained or screw retainedrestorations and terminalor interminal abutmentsupport for fixed | Coating | TiN coating | - | NA | - | TiN coating |
| Angulation | 15°/25° | - | 15°/25° | - | 15°/25° | ||||||
| Product Name | s-Clean TiN HalfCoating CoupleAbutment | Couple Abutment | - | - | Cement Abutment |
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| Dimension | Ø4.5, 4.8, 5.5 and 6.5 mm (D) x0.8, 1.3, 1.8, 2.3, 3.3, 4.3 and 5.3mm (Cuff H) | Ø4.0, 4.5, 4.8, 5.5, 6.0 and 6.5 mm (D) x0.8, 1.3, 1.8, 2.3, 3.3, 4.3 and 5.3mm (Cuff H) | - | Ø4.5/5.0/5.5/6.0/6.5 X1.0/1.5/2.0/2.5/3.0/3.5/4.0/4.5/5.0(Cuff H) | |
|---|---|---|---|---|---|
| Material | Ti-6Al-4V ELI(Grade 5) | Ti-6Al-4V ELI(Grade 5) | - | Ti-6Al-4V ELI(Grade 5) | |
| Coating | TiN coating | NA | - | TiN coating | |
| Product Name | s-Clean TiN HalfCoating Free Abutment | Free Abutment | - | - | |
| Dimension | Ø4.5, 5.5 and 6.5mm(D) x 15.36 and15.5mm (L) | Ø4.5 and 5.5 and6.5mm (D) x15.36 and 15.5mm (L) | - | - | |
| Material | Pure Titanium (Grade 4) | Pure Titanium (Grade 4) | - | - | |
| Coating | TiN coating | NA | - | - | |
| Product Name | s-Clean TiN HalfCoating FreeMillAbutment | - | - | FreeMilling Abutment | |
| Dimension | Ø4.0, 4.5, 5.5, 6.5mm(D) and 7.5mm (D) x1.3, 1.8, 2.8, 3.8 mm(Cuff H) | - | - | Ø 4.5/5.0/5.5/6.0/6.5mm (D) x1.0/2.0 /3.0mm(Cuff H) | |
| Material | Pure Titanium (Grade 4) | - | - | Pure Titanium(Grade 4) | |
| Coating | TiN coating | - | - | TiN coating | |
| Product Name | s-Clean TiN HalfCoating MOAAbutment | - | MOA Abutment | - | |
| Dimension | Ø4.5 and 5.5mm(D) x12.64, 14.14, 14.64,15.14 and 16.14mm(L) | - | Ø4.0 and 5.5mm(D) x12.64, 14.14, 14.64,15.14 and 16.14mm(L) | - | |
| Material | Ti-6Al-4V ELI(Grade5) | - | Ti-6Al-4V ELI(Grade5) | - | |
| Coating | TiN coating | - | - | - | |
| Product Name | s-Clean TiN PartialCoating Sub-OctaAbutment | Sub-Octa Abutment | - | - | |
| Dimension | Ø4.8 mm (D) x0.8, 1.3, 2.3, 3.3, 4.3and 5.3 mm (Cuff H) | Ø4.8mm (D) x0.8, 1.3, 2.3, 3.3, 4.3and 5.3 mm (Cuff H) | - | - | |
| Material | Ti-6Al-4V ELI(Grade5) | Ti-6Al-4V ELI(Grade5) | - | - | |
| Coating | TiN coating | - | - | - | |
| Product Name | s-Clean TiN PartialCoating Sole Abutment | Sole Abutment | - | Solid Abutment | |
| Dimension | Ø4.5, 5.5, 6.0 and 6.5mm (D) x 0.8, 1.3, 1.8, | Ø4.5, 5.5, 6.0 and 6.5mm (D) x 0.8, 1.3, 1.8, | - | Ø4.0/4.5/5.0/5.5/6.0/6.5/7.0X 1.0/1.5/2.0/2.5/ | |
| 2.3, 4.3, and 5.3mm(Cuff H) | 2.3 4.3 and 5.3mm(Cuff H) | 3.0/3.5/4.0/4.5/5.0 (L) | |||
| Material | Ti-6Al-4V ELI(Grade5) | Ti-6Al-4V ELI(Grade5) | Ti-6Al-4V ELI(Grade5) | ||
| Coating | TiN coating | TiN coating | |||
| Product Name | s-Clean DOA BallAbutment | O-Ring Abutment | |||
| Dimension | Ø3.5 mm (D) x 1.0, 2.0.3.0, 4.0, 5.0(Cuff H) | Ø3.5 mm (D) x 0.5, 2and 4 mm (Cuff H) | |||
| Material | Ti-6Al-4V ELI(Gradeన) | Ti-6Al-4V ELI(Grade5) | |||
| Coating | TiN coating | ||||
| Product Name | Sole Healing Cap | Sole Healing Cap | |||
| Dimension | Ø4.6, 5.1, 5.9, 6.3, 6.8and 6.9mm (D) x 6, 7,7.5 and 9 mm (L) | Ø4.9mm (D) x 4.0 mm(L) | |||
| Material | Acetal | Acetal | |||
| Sterilization | Steam sterilization byuser | Steam sterilization byuser | Steam sterilization byuser | Steam sterilization byuser | |
| Product Code | NHA | NHA | NHA | NHA | |
| Brief Discussion | The subject device is similar to the predicate devices in shape, angulation, structure, dimension, and material. Thedifference is TiN coated surface treatment of the abutments. |
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s-Clean DOA Snap Abutment
| Subject device | Primary Predicate | Reference Predicate | |
|---|---|---|---|
| 510(k) number | NA | K142211 | K171027 |
| Product Name | s-Clean TiN Coating Abutments | OT EQUATOR | Dentis Dental Implant System |
| Manufacturer | Dentis Co., Ltd. | Rhein'83 Srl | Dentis Co., Ltd. |
| Indications for Use | The s-Clean TiN Coating Abutments is anendosseous dental implant that is indicated forsurgical placement in the upper and lower jawarches, to provide a root form means for singleor multiple-units prosthetic applianceattachment to restore a patient's chewingfunction. Implants can be placed with aconventional two stage surgical process with anoption for transmucosal healing or they can beplaced in a single stage surgical process forimmediate loading when good primary stabilityhas been achieved and with appropriateocclusal loading. | The OT Equator is designed asan endosseous dental implantretentive component used toretain a complete or partialdenture. The OT Equator isscrewed into an endosseousimplant in the mandible ormaxilla.The OT Equator abutments areindicated for use with theimplant systems listed inAttachment B. | The Dentis Implant System is an endosseous dentalimplant that is indicated to use for surgical placementin the upper and lower jaw arches, to provide a rootform means for single or multiple units' prostheticappliance attachment to restore a patient's chewingfunction. Implants can be placed with a conventionaltwo stage surgical process with an option fortransmucosal healing or they can be placed in a singlestage surgical process for immediate loading.Immediate loading is restricted to the anteriormandible, based on four splinted interforminal placedimplants, and not indicated for single, unsplintedimplants. Patients must be subject for dental treatmentwith endosseous implants. |
| Product Name | s-Clean DOA Snap Abutment | OT Equator Abutment | - |
| Dimension | Ø3.5 mm (D) x 3.35 (Cuff H) | Ø2.5 mm (D) x 1-7 mm(CuffH) | - |
| Material | Ti-6Al-4V ELI(Grade 5) | Ti-6Al-4V ELI(Grade 5) | - |
| Coating | TiN coating | TiN coating | - |
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Non-Clinical Test Data
The subject device was tested to evaluate its substantial equivalence according to the following standards.
- Biocompatibility tests according to ISO 10993-1:2009, ISO 10993-3:2014, ISO 10993-5:2009, ● ISO 10993-10:2010 and ISO 10993-11:2006.
- Fatigue Testing according to ISO 14801:2007 ●
Below tests were performed for predicate devices and leveraged for the subject device:
- End User Steam Sterilization Test according to ISO 17665-1:2006, -2:2009 and ANSI/AAMI ● ST79 referenced in K161244
The results of the above tests have met the criteria of the standards, and demonstrated the substantial equivalence with the predicate device.
Biocompatibility Test was conducted for the subject devices and it demonstrates that the subject device is biocompatible and substantial equivalence with the predicate device, K153521.
The end user sterilization test was performed for predicate device. K161244 and leveraged for the subject device because the product category, material, manufacturing process, facility, and packaging is the exactly the same as the predicate, K161244.
Fatigue evaluation was performed on the subject device under worst case scenario in accordance with ISO 14801 and "Guidance for Industry and Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments".
The non-clinical testing results demonstrate that the subject device is substantially equivalent to the predicate device.
Summary of clinical testing
No clinical testing was performed for this submission.
Substantial Equivalence Discussion
Similarities:
The subject device has identical, machining, manufacturing process, angulation and indication for use and similar design, dimension and technological characteristics as the predicate devices.
The subject device has been supposed to performance and product validations prior to release. Testing including biocompatibility tests and fatigue test has been performed to ensure the devices comply with the applicable International and US FDA Guidance.
Differences:
The differences between the subject device and predicate devices are detailed shape and dimension of each abutment and area of TiN Coated surface treatment.
Any differences between the subject device and predicate devices do not raise new types of substantially equivalent issues.
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Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification Dentis Co., Ltd. Concludes that the s-Clean TiN Coating Abutments is substantially equivalent to the predicate devices as described herein.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)