Who is the manufacturer of s-Clean TiN Coating Abutments?

Dentis Co., Ltd. filed the 510(k) submission for s-Clean TiN Coating Abutments (K171694).

What is the FDA product code for s-Clean TiN Coating Abutments?

NHA. It is classified under 21 CFR 872.3630 as a Class 2 device in the Dental panel.

What is the regulatory pathway for s-Clean TiN Coating Abutments?

510(k) clearance (submission type: Traditional).

What are the predicate devices for s-Clean TiN Coating Abutments?

Dentis Dental Implant System (K171027); Dentis Dental Implant System (K082843); Haptite Coating Implant System (K111364); S-Clean Oneq-sl Narrow Implant System (K161244); IH Prosthetic System (K153521); OT Equator (K142211).

Who can help prepare an FDA 510(k) submission like s-Clean TiN Coating Abutments?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

s-Clean TiN Coating Abutments

K171694 · Dentis Co., Ltd. · NHA · Nov 29, 2017 · Dental

Device Facts

Record ID	K171694
Device Name	s-Clean TiN Coating Abutments
Applicant	Dentis Co., Ltd.
Product Code	NHA · Dental
Decision Date	Nov 29, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3630
Device Class	Class 2
Attributes	Therapeutic

Intended 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.

Device Story

s-Clean TiN Coating Abutments are dental abutments used as an interface between endosseous dental implants and prosthetic appliances. Fabricated from Ti-6Al-4V ELI (Grade 5) or Pure Titanium (Grade 4), the devices feature a Titanium Nitride (TiN) coating applied via Physical Vapor Deposition (PVD). The system includes various configurations (angled, couple, free, free-mill, MOA, sub-octa, sole, ball, and snap abutments) and healing caps. Used in dental clinics by clinicians, the abutments are attached to compatible Dentis implant fixtures to restore chewing function. The device is provided non-sterile and requires end-user steam sterilization. The TiN coating is intended to modify surface characteristics. Clinical decision-making relies on the clinician's assessment of implant stability and prosthetic requirements. Benefits include restoration of masticatory function for edentulous or partially edentulous patients.

Clinical Evidence

No clinical testing was performed for this submission. Substantial equivalence is supported by bench testing, including biocompatibility (ISO 10993-1, -3, -5, -10, -11) and fatigue testing (ISO 14801).

Technological Characteristics

Materials: Ti-6Al-4V ELI (Grade 5) and Pure Titanium (Grade 4). Surface treatment: TiN coating via PVD. Sterilization: Steam sterilization by end-user (ISO 17665-1, -2; ANSI/AAMI ST79). Mechanical testing: Fatigue testing per ISO 14801.

Indications for Use

Indicated for patients requiring dental restoration via endosseous implants in upper or lower jaw arches; supports single or multiple-unit prosthetic appliances; suitable for two-stage surgical process with transmucosal healing or single-stage process with immediate loading given sufficient primary stability.

Regulatory Classification

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.

Special Controls

*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.)

Predicate Devices

Dentis Dental Implant System (K171027)
Dentis Dental Implant System (K082843)
Haptite Coating Implant System (K111364)
S-Clean Oneq-sl Narrow Implant System (K161244)
IH Prosthetic System (K153521)
OT Equator (K142211)

Related Devices

K241183 — ISO Abutment · Seum Medi Co., Ltd. · Jul 28, 2025
K210134 — Dentis s-Clean s-Line · Dentis Co., Ltd. · Apr 19, 2021
K193046 — Straumann® Retentive System Novaloc TiN Abutments · Institut Straumann AG · Aug 13, 2020
K233194 — TS Abutment System · Osstem Implant Co., Ltd. · Feb 20, 2024
K221969 — IU Implant System Abutment · Warantec Co., Ltd. · May 12, 2023

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ ## 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ #### 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) {4}------------------------------------------------ - 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 Fixture s-Clean SAVE Fixture | Diameters: Ø3.7, 4.3, 4.8, 5.5, 6.0 Length: 7, 8, 10, 12, 14mm | | Dentis Dental Implant System (K082843) | s-Clean SAVE Fixture | Diameters: Ø6.5, 7.0 Lengths:7, 8, 10, 12mm | | Haptite Coating Implant System (K111364) | HAPTITE s-Clean Tapered Fixture HAPTITE s-Clean Straight Fixture HAPTITE s-Clean SAVE Fixture | Diameters: Ø3.7, 4.1, 4.3, 4.8, 5.5, 6.0, 6.5, 7.0 Lengths:7, 8, 10, 12, 14mm | | Dentis Dental Implant System (K150344) | s-Clean Tapered Fixture | Diameters: Ø3.7, 4.1, 4.8 Lengths: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, 8.0 Lengths:7, 8, 10, 12, 14mm | | s-clean tapered ii rbm implant system (K160213) | s-Clean Tapered II RBM Fixture | Diameters: Ø3.7, 4.1, 4.3, 4.8 Lengths: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. {5}------------------------------------------------ #### 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 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. | 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. | two stage surgical procedures and not for immediate load. Also, this system is intended to be used in the molar region. | is dedicated for one and two stage surgical procedures and not dedicated for immediate loading. This system is intended for delayed loading. | bridgework. IH Implant System is for single and two stage surgical procedures. It is intended for delayed loading. | |---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------| | 510(k) number | NA | K171027 | K082843 | K111364 | K153521 | Product Name | s-Clean TiN Half Coating Angled Abutment | - | Submerged Angled Abutment | - | Angled Abutment | | Product Name | s-Clean TiN Coating Abutments | Dentis Dental Implant System | Dentis Dental Implant System | Haptite Coating Implant System | IH Prosthetic System | Dimension | Ø4.5, 5.0, 5.5 and 6.5 mm (D) x 10.18, 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 6.5 mm (D) x 9, 10.5, 12 mm (L) | - | Ø 4.5/5.0/5.5 /6.0 X 9.5, 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(Grade 5) | - | Ti-6Al-4V ELI(Grade 5) | - | Ti-6Al-4V ELI(Grade 5) | | Indications 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 | The Dentis Dental Implant System 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 | The Dentis Dental 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 bridgework. This system is dedicated for one and | The HAPTITE Coating 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 bridgework. This system | IH Implant System is device made of titanium and titanium alloy indicated for in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained or screw retained restorations and terminal or interminal abutment support for fixed | Coating | TiN coating | - | NA | - | TiN coating | | Angulation | 15°/25° | - | 15°/25° | - | 15°/25° | | | | | | | | Product Name | s-Clean TiN Half Coating Couple Abutment | Couple Abutment | - | - | Cement Abutment | | | | | | | {6}------------------------------------------------ {7}------------------------------------------------ | Dimension | 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) | Ø4.0, 4.5, 4.8, 5.5, 6.0 and 6.5 mm (D) x 0.8, 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 X 1.0/1.5/2.0/2.5 /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 Half Coating Free Abutment | Free Abutment | - | - | | | Dimension | Ø4.5, 5.5 and 6.5mm (D) x 15.36 and 15.5mm (L) | Ø4.5 and 5.5 and 6.5mm (D) x 15.36 and 15.5mm (L) | - | - | | | Material | Pure Titanium (Grade 4) | Pure Titanium (Grade 4) | - | - | | | Coating | TiN coating | NA | - | - | | | Product Name | s-Clean TiN Half Coating FreeMill Abutment | - | - | FreeMilling Abutment | | | Dimension | 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) | - | - | Ø 4.5/5.0 /5.5/6.0/6.5mm (D) x 1.0/2.0 /3.0mm (Cuff H) | | | Material | Pure Titanium (Grade 4) | - | - | Pure Titanium (Grade 4) | | | Coating | TiN coating | - | - | TiN coating | | | Product Name | s-Clean TiN Half Coating MOA Abutment | - | MOA Abutment | - | | | Dimension | Ø4.5 and 5.5mm(D) x 12.64, 14.14, 14.64, 15.14 and 16.14mm(L) | - | Ø4.0 and 5.5mm(D) x 12.64, 14.14, 14.64, 15.14 and 16.14mm(L) | - | | | Material | Ti-6Al-4V ELI(Grade 5) | - | Ti-6Al-4V ELI(Grade 5) | - | | | Coating | TiN coating | - | - | - | | | Product Name | s-Clean TiN Partial Coating Sub-Octa Abutment | Sub-Octa Abutment | - | - | | | Dimension | Ø4.8 mm (D) x 0.8, 1.3, 2.3, 3.3, 4.3 and 5.3 mm (Cuff H) | Ø4.8mm (D) x 0.8, 1.3, 2.3, 3.3, 4.3 and 5.3 mm (Cuff H) | - | - | | | Material | Ti-6Al-4V ELI(Grade 5) | Ti-6Al-4V ELI(Grade 5) | - | - | | | Coating | TiN coating | - | - | - | | | Product Name | s-Clean TiN Partial Coating Sole Abutment | Sole Abutment | - | Solid Abutment | | | Dimension | Ø4.5, 5.5, 6.0 and 6.5 mm (D) x 0.8, 1.3, 1.8, | Ø4.5, 5.5, 6.0 and 6.5 mm (D) x 0.8, 1.3, 1.8, | - | Ø4.0/4.5/5.0/5.5/ 6.0/6.5/7.0 X 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(Grade 5) | Ti-6Al-4V ELI(Grade 5) | | | Ti-6Al-4V ELI(Grade 5) | | Coating | TiN coating | | | | TiN coating | | Product Name | s-Clean DOA Ball Abutment | 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, 2 and 4 mm (Cuff H) | | | | | Material | Ti-6Al-4V ELI(Grade న) | Ti-6Al-4V ELI(Grade 5) | | | | | Coating | TiN coating | | | | | | Product Name | Sole Healing Cap | | | Sole Healing Cap | | | Dimension | Ø4.6, 5.1, 5.9, 6.3, 6.8 and 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 by user | Steam sterilization by user | Steam sterilization by user | Steam sterilization by user | | | Product Code | NHA | NHA | NHA | NHA | | | Brief Discussion | The subject device is similar to the predicate devices in shape, angulation, structure, dimension, and material. The difference is TiN coated surface treatment of the abutments. | | | | | {8}------------------------------------------------ {9}------------------------------------------------ K171694 {10}------------------------------------------------ # 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 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. | The OT Equator is designed as an endosseous dental implant retentive component used to retain a complete or partial denture. The OT Equator is screwed into an endosseous implant in the mandible or maxilla. The OT Equator abutments are indicated for use with the implant systems listed in Attachment B. | The Dentis Implant System is an endosseous dental implant that is indicated to use 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. Immediate loading is restricted to the anterior mandible, based on four splinted interforminal placed implants, and not indicated for single, unsplinted implants. Patients must be subject for dental treatment with 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(Cuff H) | - | | Material | Ti-6Al-4V ELI(Grade 5) | Ti-6Al-4V ELI(Grade 5) | - | | Coating | TiN coating | TiN coating | - | {11}------------------------------------------------ ## 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. {12}------------------------------------------------ # 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.