(109 days)
No
The summary describes a physical dental abutment and its components, materials, and compatibility with CAD/CAM systems for design and milling. There is no mention of AI or ML being used in the device itself or in the design/manufacturing process described.
No
The device is an abutment for dental implants, providing support for prosthetic restorations. It is a mechanical component of a dental restoration system and does not itself treat or prevent a disease or condition.
No
Explanation: The s-Clean Link Abutment is described as a support for dental prostheses (crowns and bridges) and is intended for use in the placement of these restorations. Its function is to hold a prosthetic in place, not to diagnose a medical condition.
No
The device description clearly states it is a physical, two-piece abutment made of titanium alloy and zirconia, intended for use with dental implants. While it mentions the use of CAD/CAM software for designing the coping, the device itself is a physical implant component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the s-Clean Link Abutment is for use with dental implants as a support for prostheses in the maxilla or mandible of a patient. This is a direct application within the human body for structural support, not for testing samples outside the body to diagnose or monitor a condition.
- Device Description: The description details the materials and components of a dental abutment, which is a physical device implanted to connect a dental prosthesis to a dental implant.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.), detect specific analytes, or provide diagnostic information about a patient's health status.
The device is a medical device, specifically a dental prosthetic component, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
s-Clean Link Abutment is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
s-Clean Link Abutment is intended for use with the Dentis s-Clean s-Line and Dentis s-Clean s-Line Mini according to connector part in the chart. All digitally designed zirconia for use with s-Clean Link Abutment are intended to be manufactured at a Dentis validated milling center.
Product codes
NHA
Device Description
The s-Clean Link Abutment is intended to provide support for customized prosthetic restorations such as crowns and bridges. The s-Clean Link Abutment is composed of two-piece abutment that is a link abutment at the bottom, a coping (CAD/CAM patient specific superstructure) at the top and screw. The bottom link abutment portion of the s-Clean Link Abutment is pre-manufactured (stock) made from a titanium alloy conforming to ASTM F136. The Top half of the s-Clean Link Abutment is composed of zirconia conforming to ISO 6872 reference to prior cleared ceramic, K141724.
s-Clean Abutment Screw s-Line is made of Ti-6AI-4V ELI (ASTM F136)
The diameters of s-Clean Link Abutment are 4.5 and 4.8mm.
s-Clean Link Abutment is provided non-sterile therefore must be sterilized after the cementation of the patient-specific superstructure on the Link Abutment.
The proposed devices are compatible with the following device.
Raw material blanks
- K141724, Upcera Dental Zirconia Blank & Dental Zircornia Pre-Shaded Blank by Liaoning Upcera Co.. Ltd.
Raw material cement - K191122, 3M RelyX Pediatric Resin Modified Glass Ionomer Cement by 3M ESPE Dental Product.
The coping that composes the final abutment should be designed and milled through the CAD/CAM software, according to the prosthetic planning and patient clinical situation. The coping and crowns designed using these or more recent versions of the CAD/CAM System, within the design limits as defined within the design software, are compatible with the link abutment.
The coping would be manufactured by Dentis only with design input using CAD/CAM Software from and by Dentis milling center.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxilla or mandible
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing:
- End User Steam Sterilization Tests on s-Clean Link abutment cemented to zirconia top according to ISO 17665-1:2006, 17665-2:2009 and ANSI/AAMI ST79:2010.
- Biocompatibility tests on s-Clean Link abutment according to ISO 10993-1:2009, ISO 10993-5:2009.
- Cytotoxicity testing on s-Clean Link Abutment cemented to zirconia superstructure according to ISO 10993-5:2009.
Key Results: The results of the above tests have met the criteria of the standard and demonstrated substantial equivalence with the predicate device.
MR Environment Condition:
- Non-clinical worst-case MRI review was performed to evaluate the metallic s-Clean Link Abutment devices in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan. "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795), based on the entire system including all variations (all compatible implant bodies, dental abutments, and fixation screws) and material composition.
- Rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K210080, K210134, K141724, K191122
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.)
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Dentis Co., Ltd. % April Lee Consultant Withus Group Inc 106 Superior Irvine, California 92620
Re: K222913
Trade/Device Name: s-Clean Link Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: December 9, 2022 Received: December 9, 2022
Dear April Lee:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-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 -S
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
2
Indications for Use
510(k) Number (if known)
Device Name
s-Clean Link Abutment
Indications for Use (Describe)
s-Clean Link Abutment is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
| No. | Subject Device | Implant System
Compatibility | Implant Diameter
(mm) | Platform Diameter
(mm) | K number |
|-----|----------------------------------|---------------------------------|--------------------------|---------------------------|----------|
| 1 | s-Clean Link
Abutment Regular | Dentis s-Clean s-Line | Ø5.8, 6.8 and 7.8 | Ø4.3, 4.5 | K210134 |
| 2 | s-Clean Link
Abutment Mini | Dentis s-Clean s-Line
Mini | Ø5.8, 6.8 and 7.8 | Ø4.3, 4.5 | K210080 |
s-Clean Link Abutment is intended for use with the Dentis s-Clean s-Line and Dentis s-Clean s-Line Mini according to connector part in the chart. All digitally designed zirconia for use with s-Clean Link Abutment are intended to be manufactured at a Dentis validated milling center.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
Submitter
Dentis Co., Ltd. Gyu Ri Kim 99, Seongseoseo-ro, Dalseo-gu Daegu, 42718 Korea Email: kgr1026@dentis.co.kr Tel. +82-53-589-3541 Fax. +82-53-289-7922
Device Information
- Trade Name: s-Clean Link Abutment
- Common Name: Endosseous Dental Implant Abutment ●
- Classification Name: Abutment, Implant, Dental, Endosseous
- . Product Code: NHA
- . Panel: Dental
- Regulation Number: 21 CFR 872.3630 ●
- Device Class: Class II
- Date prepared: 01/12/2023 ●
Predicate Devices:
Primary Predicate
-
K181037, DIO CAD/CAM Abutment by DIO CORPORATION ●
Reference Device -
K210080, Dentis s-Clean s-Line Mini by Dentis Co., Ltd
-
K210134, Dentis s-Clean s-Line by Dentis Co., Ltd ●
-
K141724, UPCERA DENTAL ZIRCONIA BLANK & DENTAL ZIRCONIA PRE-SHADED BLANK by ● LIAONING UPCERA Co., Ltd.
-
K191122, 3M RelyX Pediatric Resin Modified Glass Ionomer Cement by 3M ESPE Dental Products
Indication for Use:
s-Clean Link Abutment is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
| No. | Subject Device | Implant System
Compatibility | Implant Diameter
(mm) | Platform Diameter
(mm) | K number |
|-----|----------------------------------|---------------------------------|--------------------------|---------------------------|----------|
| 1 | s-Clean Link
Abutment Regular | Dentis s-Clean s-Line | Ø5.8, 6.8 and 7.8 | Ø4.3, 4.5 | K210134 |
| 2 | s-Clean Link
Abutment Mini | Dentis s-Clean s-Line
Mini | Ø5.8, 6.8 and 7.8 | Ø4.3, 4.5 | K210080 |
s-Clean Link Abutment is intended for use with the Dentis s-Clean s-Line and Dentis s-Clean s-Line Mini according to connector part in the chart. All digitally designed zirconia for use with s-Clean Link Abutment are intended to be manufactured at a Dentis validated milling center.
Official Correspondent
Withus Group Inc. April Lee 106 Superior, Irvine, CA 92620 USA Email: withus6664@gmail.com Phone: 1-909-274-9971 Fax: 1-909-460-8122
4
Device Description:
The s-Clean Link Abutment is intended to provide support for customized prosthetic restorations such as crowns and bridges. The s-Clean Link Abutment is composed of two-piece abutment that is a link abutment at the bottom, a coping (CAD/CAM patient specific superstructure) at the top and screw. The bottom link abutment portion of the s-Clean Link Abutment is pre-manufactured (stock) made from a titanium alloy conforming to ASTM F136. The Top half of the s-Clean Link Abutment is composed of zirconia conforming to ISO 6872 reference to prior cleared ceramic, K141724.
s-Clean Abutment Screw s-Line is made of Ti-6AI-4V ELI (ASTM F136)
The diameters of s-Clean Link Abutment are 4.5 and 4.8mm.
s-Clean Link Abutment is provided non-sterile therefore must be sterilized after the cementation of the patientspecific superstructure on the Link Abutment.
The proposed devices are compatible with the following device.
| Dental Implants | ||
|---|---|---|
| Subject Abutment | s-Clean Link Abutment Regular | s-Clean Link Abutment Mini |
| Compatible Implants | ||
| (Knumber) | Dentis s-Clean s-Line | |
| (K210134) | Dentis s-Clean s-Line Mini | |
| (K210080) | ||
| Implant diameter size | Ø5.8, 6.8 and 7.8 | Ø5.8, 6.8 and 7.8 |
| Platform diameter size | Ø4.3, 4.5 | Ø4.3, 4.5 |
| Implant Interface Connection | ||
| Type/Size(mm) | Internal connection type / 2.5Hex | Internal connection type / 2.1Hex |
| Type of Implant-Abutment | ||
| Connection | Hex/Non Hex | Hex/Non Hex |
Raw material blanks
- K141724, Upcera Dental Zirconia Blank & Dental Zircornia Pre-Shaded Blank by Liaoning Upcera ● Co.. Ltd.
Raw material cement
- K191122, 3M RelyX Pediatric Resin Modified Glass Ionomer Cement by 3M ESPE Dental Product .
The coping that composes the final abutment should be designed and milled through the CAD/CAM software, according to the prosthetic planning and patient clinical situation. The coping and crowns designed using these or more recent versions of the CAD/CAM System, within the design limits as defined within the design software, are compatible with the link abutment.
The coping would be manufactured by Dentis only with design input using CAD/CAM Software from and by Dentis milling center.
Design Limitation for Superstructure:
| | Zirconia for s-Clean Link Abutment
Regular | Zirconia for s-Clean Link Abutment
Mini |
|-------------------------------------------------------------|-----------------------------------------------|--------------------------------------------|
| Minimum wall thickness | 0.5 | 0.5 |
| Minimum/Maximum Post Height for
single-unit restorations | 4.45 | 4.45 |
| Maximum gingival height in the
zirconia superstructure | 0 | 0 |
| Minimum gingival height in the Link
Abutment | 1 | 1 |
| Maximum angulation | 0 | 0 |
5
Summaries of Technology Characteristics
The subject device is substantially equivalent to the current cleared devices. They are substantial and connection interfaces to the implants are identical diameter and connection type. Comparison demonstrating Substantial Equivalence follows:
| Subject Device | Primary Predicate | |
|---|---|---|
| Applicant | Dentis Co., Ltd | DIO CORPORATION |
| Trade Name | s-Clean Link Abutment | DIO CAD/CAM Abutment |
| 510(k) No. | N/A | K181037 |
| Classification Name | Endossoeus Dental Implant Abutment | Endossoeus Dental Implant Abutment |
| Product Code | NHA | NHA |
| Class | Class II | Class II |
| Design | Image: Dentis Co., Ltd s-Clean Link Abutment | Image: DIO CAD/CAM Abutment |
| Base Material | Ti-6Al-4V ELI (ASTM F136) | Ti-6Al-4V ELI (ASTM F136) |
| Diameter (mm) | 4.5 and 4.8 | 4.0, 4.5 and 5.5 |
| Superstructure | ||
| Angulation | 0 ° | 0~15° |
| Superstructure | ||
| material | Zirconia | Zirconia |
| Sterile | End-User Sterile | End-User Sterile |
| Type of Retention | Fixture-Link Abutment : Screw | |
| Link Abutment-Zirconia Coping : Cement | Fixture-Link Abutment : Screw | |
| Link Abutment-Zirconia Coping : Cement | ||
| Zirconia Superstructure Design Parameters | ||
| Minimum Diameter | ||
| (mm) | 4.5 | 4.0 |
| Minimum Post Wall | ||
| Thickness (mm) | 0.5 | 0.5 |
| Maximum Gingival | ||
| Height in the Zirconia | ||
| superstructure | 0 | 0 |
| Angulation (°) | 0 | 0-15° |
6
| s-Clean Link Abutment is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. | DIO CAD/CAM Abutment is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Indications For Use/ | |||||||||||
| Intended Use | N | Subject Device | Implant System | ||||||||
| Compatibility | Implant Diameter (mm) | Platform Diameter (mm) | K number | Implant System | |||||||
| Compatibility | Implant Diameter (mm) | Platform Diameter (mm) | |||||||||
| 0 | |||||||||||
| 1 | s-Clean Link | ||||||||||
| Abutment | |||||||||||
| Regular | Dentis s-Clean | ||||||||||
| s-Line | $Ø$ 5.8, | ||||||||||
| 6.8 and | |||||||||||
| 7.8 | $Ø$ 4.3, | ||||||||||
| 4.5 | K210134 | UF(II) Narrow | |||||||||
| Implant System | 3.0/3.3 | 3.0/3.3 | |||||||||
| 2 | s-Clean Link | ||||||||||
| Abutment | |||||||||||
| Mini | Dentis s-Clean | ||||||||||
| s-Line Mini | $Ø$ 5.8, | ||||||||||
| 6.8 and | |||||||||||
| 7.8 | $Ø$ 4.3, | ||||||||||
| 4.5 | K210080 | UF Submerged | |||||||||
| Implant System | 3.8/4.0/4.5/5.0/5.5/6.0/6 | ||||||||||
| .5/7.0 | 3.8/4.0/4.5/5.0/5.5/6 | ||||||||||
| .0/6.5/7.0 | |||||||||||
| UF(II) | |||||||||||
| Implant System | 3.8/4.0/4.5/5.0/5.5 | 3.8/4.0/4.5/5.0/5.5 | |||||||||
| s-Clean Link Abutment is intended for use with the Dentis s-Clean s-Line and Dentis s-Clean s-Line Mini according to connector part in the chart. All digitally designed zirconia for use with s-Clean Link Abutment are intended to be manufactured at a Dentis validated milling center. | Patient specific abutment is intended for use with the UF Implant System provided in the chart. All digitally designed abutment for use with DIO CAD/CAM Abutments are intended to be manufactured at a DIO Corporation validated milling center. | ||||||||||
| Substantial | |||||||||||
| Equivalence | |||||||||||
| Comparison | The subject s-Clean Link Abutment is substantially equivalent in designs, dimensions, material, indication, superstructure and sterile method with the identified primary predicate device. The s-Clean Link Abutment is similar in fundamental scientific technology to the predicate device in that they all have been designed, manufactured and tested in compliance with FDA's Class II special controls guidance document root-food endosseous dental implants and endosseous dental implant abutments. | ||||||||||
| The diameters of the subject device are slightly different from the predicate device. However, the subject diameters are in the range of diameters of predicates and this dimensional difference doesn't affect device safety and effectiveness. | |||||||||||
| The Indications for Use of the subject and primary predicate device are identical other than the compatible implant bodies. | |||||||||||
| Both the predicate and subject devices are intended to be milled into patient specific abutments using CAD/CAM technology under the manufacturing control of the sponsor. Any differences in technology characteristics are accompanied by information that demonstrated the device is substantially equivalent as the predicate and do not raise different questions of safety and effectiveness than the predicate |
7
| Subject Device | Primary Predicate | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Applicant | Dentis Co., Ltd | DIO CORPORATION | ||||||||||||||||||
| Trade Name | s-Clean Link Abutment | DIO CAD/CAM Abutment | ||||||||||||||||||
| 510(k) No. | N/A | K181037 | ||||||||||||||||||
| Classification Name | Endossoeus Dental Implant Abutment | Endossoeus Dental Implant Abutment | ||||||||||||||||||
| Product Code | NHA | NHA | ||||||||||||||||||
| Class | Class II | Class II | ||||||||||||||||||
| Design | Image: dental implants | Image: dental implant | ||||||||||||||||||
| Base Material | Ti-6Al-4V ELI (ASTM F136) | Ti-6Al-4V ELI (ASTM F136) | ||||||||||||||||||
| Diameter (mm) | 4.0, 4.5 and 4.8 | 4.0, 4.5 and 5.5 | ||||||||||||||||||
| Superstructure | ||||||||||||||||||||
| Angulation | 0 ° | 0~15° | ||||||||||||||||||
| Superstructure | ||||||||||||||||||||
| material | Zirconia | Zirconia | ||||||||||||||||||
| Sterile | End-User Sterile | End-User Sterile | ||||||||||||||||||
| Type of Retention | Fixture-Link Abutment : Screw | |||||||||||||||||||
| Link Abutment-Zirconia Coping : Cement | Fixture-Link Abutment : Screw | |||||||||||||||||||
| Link Abutment-Zirconia Coping : Cement | ||||||||||||||||||||
| Zirconia Superstructure Design Parameters | ||||||||||||||||||||
| Minimum Diameter | ||||||||||||||||||||
| (mm) | 4.0 | 4.0 | ||||||||||||||||||
| Minimum Post Wall | ||||||||||||||||||||
| Thickness (mm) | 0.5 | 0.5 | ||||||||||||||||||
| Maximum Gingival | ||||||||||||||||||||
| Height in the Zirconia | ||||||||||||||||||||
| superstructure | 0 | 0 | ||||||||||||||||||
| Angulation (°) | 0 | 0-15° | ||||||||||||||||||
| Indications For Use/ | ||||||||||||||||||||
| Intended Use | s-Clean Link Abutment is intended for use with dental implants | |||||||||||||||||||
| as a support for single or multiple tooth prostheses in the | ||||||||||||||||||||
| maxilla or mandible of a partially or fully edentulous patient. | ||||||||||||||||||||
| N Subject | ||||||||||||||||||||
| Device Implant | ||||||||||||||||||||
| System | ||||||||||||||||||||
| Compatibility Implant | ||||||||||||||||||||
| Diameter | ||||||||||||||||||||
| r (mm) Platform | ||||||||||||||||||||
| Diameter | ||||||||||||||||||||
| r (mm) K number 0 | DIO CAD/CAM Abutment is intended for use with dental | |||||||||||||||||||
| implants as a support for single or multiple tooth prostheses in | ||||||||||||||||||||
| the maxilla or mandible of a partially or fully edentulous | ||||||||||||||||||||
| patient. | ||||||||||||||||||||
| Implant System Implant Diameter Platform Diameter |
8
| Compatibility | (mm) | (mm) | |||||||
|---|---|---|---|---|---|---|---|---|---|
| 1 | s-Clean Link | ||||||||
| Abutment | |||||||||
| Regular | Dentis s-Clean | ||||||||
| s-Line | Ø5.8, | ||||||||
| 6.8 and | |||||||||
| 7.8 | Ø4.3, | ||||||||
| 4.5 | K210134 | UF(II) Narrow | |||||||
| Implant System | 3.0/3.3 | 3.0/3.3 | |||||||
| 2 | s-Clean Link | ||||||||
| Abutment | |||||||||
| Mini | Dentis s-Clean | ||||||||
| s-Line Mini | Ø5.8, | ||||||||
| 6.8 and | |||||||||
| 7.8 | Ø4.3, | ||||||||
| 4.5 | K210080 | UF Submerged | |||||||
| Implant System | 3.8/4.0/4.5/5.0/5.5/6.0/6 | ||||||||
| .5/7.0 | 3.8/4.0/4.5/5.0/5.5/6 | ||||||||
| .0/6.5/7.0 | |||||||||
| s-Clean Link Abutment is intended for use with the Dentis s-Clean s-Line and Dentis s-Clean s-Line Mini according to connector part in the chart. All digitally designed zirconia for use with s-Clean Link Abutment are intended to be manufactured at a Dentis validated milling center. | UF(II) | ||||||||
| Implant System | 3.8/4.0/4.5/5.0/5.5 | 3.8/4.0/4.5/5.0/5.5 | |||||||
| Patient specific abutment is intended for use with the UF Implant System provided in the chart. All digitally designed abutment for use with DIO CAD/CAM Abutments are intended to be manufactured at a DIO Corporation validated milling center. | |||||||||
| Substantial | |||||||||
| Equivalence | |||||||||
| Comparison | The subject s-Clean Link Abutment is substantially equivalent in designs, dimensions, material, indication, superstructure and sterile method with the identified primary predicate device. The s-Clean Link Abutment is similar in fundamental scientific technology to the predicate device in that they all have been designed, manufactured and tested in compliance with FDA's Class II special controls guidance document root-food endosseous dental implants and endosseous dental implant abutments. | ||||||||
| The diameters of the subject device are slightly different from the predicate device. However, the subject diameters are in the range of diameters of predicates and this dimensional difference doesn't affect device safety and effectiveness. | |||||||||
| The Indications for Use of the subject and primary predicate device are identical other than the compatible implant bodies. | |||||||||
| Both the predicate and subject devices are intended to be milled into patient specific abutments using CAD/CAM technology under the manufacturing control of the sponsor. Any differences in technology characteristics are accompanied by information that demonstrated the device is substantially equivalent as the predicate and do not raise different questions of safety and effectiveness than the predicate. |
9
Non-Clinical Testing
The subject device was tested to evaluate its substantial equivalence according to the following standards.
- End User Steam Sterilization Tests on s-Clean Link abutment cemented to zirconia top ● according to ISO 17665-1:2006, 17665-2:2009 and ANSI/AAMI ST79:2010
- Biocompatibility tests on s-Clean Link abutment according to ISO 10993-1:2009, ISO 10993-5:2009
- Cytotoxicity testing on s-Clean Link Abutment cemented to zirconia superstructure according to ISO 10993-5:2009
Biocompatibility test was performed on subject Link abutment and subject link abutment cemented to the zirconia top. The results of the above tests have met the criteria of the standard and demonstrated substantial equivalence with the predicate device.
Non-clinical testing was conducted in accordance with FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments".
For all subject devices delivered non-sterile to be end-user sterilized, the recommended sterilization has been validated according to ISO 17665-1 and ISO 17665-2 and to applicable recommendations in the FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued on March 17, 2015". The worst-case construct was tested, and the result report is attached.
MR Environment Condition
Non-clinical worst-case MRI review was performed to evaluate the metallic s-Clean Link Abutment devices in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan. "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795), based on the entire system including all variations (all compatible implant bodies, dental abutments, and fixation screws) and material composition.
Rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque.
Clinical testing was not necessary to establish substantial equivalency of the device.
Conclusion
The s-Clean Link Abutment 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 device. Therefore, s-Clean Link Abutment and its predicates are substantially equivalent