(86 days)
No
The description focuses on the physical components and materials of a dental abutment and its intended use in supporting prostheses. There is no mention of AI or ML in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is a dental abutment intended to support prostheses, which directly contributes to the restoration of dental function and aesthetics, thus serving a therapeutic purpose.
No
Explanation: The device is an abutment for dental implants, designed to support prostheses. Its intended use and device description focus on structural support and material composition, with no mention of diagnosis or diagnostic functions.
No
The device description clearly states the device is a physical abutment made of titanium alloy and zirconia, and includes an abutment fixation screw. It is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The s-Clean Link Abutment Narrow is a dental implant component used to support prosthetic restorations (crowns and bridges) in the mouth. It is a physical device implanted into the body.
- Lack of Specimen Analysis: The description does not mention any analysis of biological specimens.
- Anatomical Site: The device is used directly within the oral cavity, not for testing samples taken from the body.
Therefore, the s-Clean Link Abutment Narrow is a medical device, specifically a dental implant 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 Narrow is intended for use with dental implant as a support for single or multiple tooth prostheses in mandibular central and lateral incisors and maxillary lateral incisors.
s-Clean Link Abutment Narrow is intended for use with the s-Clean OneQ-SL Narrow Fixture according to connector part in the chart. All digitally designed zirconia for use with s-Clean Link Abutment Narrow are intended to be manufactured at a Dentis validated milling center.
Product codes
NHA
Device Description
The s-Clean Link Abutment Narrow is intended to provide support for customized prosthetic restorations such as crowns and bridges. The s-Clean Link Abutment is composed of a two-piece abutment that is a link abutment at the bottom and a coping (CAD/CAM patient specific superstructure) as the top-half. The submission also includes an abutment fixation screw. The s-Clean Link Abutment are pre-manufactured (stock) abutments, made from a titanium alloy conforming to ASTM F136. The top half of the s-Clean link abutment composed of zirconia is referenced from our previously cleared K222913 submission. s-Clean Abutment Screw is made of Ti-6Al-4V ELI (ASTM F136) and cleared in K161244. The diameters of s-Clean Link Abutment Narrow are 4.0 and 4.5mm. s-Clean Link Abutment Narrow is provided non-sterile and must be sterilized after the cementation of the patient-specific superstructure on the Link Abutment Narrow.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandibular central and lateral incisors and maxillary lateral incisors.
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 Sterilization Validation test for s-Clean Link abutment cemented to zirconia top according to ISO 17665-1:2006, 17665-2:2009 and ANSVAAMI ST79:2010 referenced in K222193. The end user sterilization test was leveraged from the predicate device K222193 because the product category, material, manufacturing process, facility, and packaging are the same.
- Biocompatibility tests on s-Clean Link abutment according to ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-10:2010 and ISO 10993-11:2017 referenced in K222913. This testing was conducted on the predicate device K222193 and leveraged for the subject device because both products are manufactured with the same materials and manufacturing process, demonstrating the subject device's biocompatibility and substantial equivalence.
- Cytotoxicity testing on s-Clean Link Abutment cemented to zirconia superstructure according to ISO 10993-5:2009 referenced in K222193.
MR Environment Condition:
Non-clinical worst-case MRI review was performed to evaluate the metallic s-Clean Link Abutment Narrow 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. The subject device and primary predicate device have MR conditional labeling.
Clinical testing was not necessary to establish substantial equivalency of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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: K230523
Trade/Device Name: s-Clean Link Abutment Narrow Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: February 25, 2023 Received: February 27, 2023
Dear April Lee:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976. the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely. Andrew 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K230523
Device Name s-Clean Link Abutment Narrow
Indications for Use (Describe)
s-Clean Link Abutment Narrow is intended for use with dental implant as a support for single or multiple tooth prostheses in mandibular central and lateral incisors and maxillary lateral incisors.
| No. | Subject Device | Implant System
Compatibility | Implant Diameter (Ø) | Platform Diameter
(Ø) | K number |
|-----|---------------------------------|------------------------------------------|----------------------|--------------------------|----------|
| 1 | s-Clean Link
Abutment Narrow | s-Clean OneQ-SL
Narrow Implant System | 3.3 | 3.3 | K161244 |
s-Clean Link Abutment Narrow is intended for use with the s-Clean OneQ-SL Narrow Fixture according to connector part in the chart. All digitally designed zirconia for use with s-Clean Link Abutment Narrow 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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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 Narrow
- Common Name: Endosseous Dental Implant Abutment ●
- . Classification Name: Abutment, Implant, Dental, Endosseous
- Product Code: NHA
- Panel: Dental ●
- Regulation Number: 872.3630
- Device Class: Class II ●
- Date prepared: 05/23/2023 ●
Predicate Devices:
Primary Predicate
- K222913, s-Clean Link Abutment by Dentis Co., Ltd. ●
Reference Device
- K161244, s-Clean OneQ-SL Narrow Implant System by Dentis Co.,Ltd
Indications for Use:
s-Clean Link Abutment Narrow is intended for use with dental implant as a support for single or multiple tooth prostheses in mandibular central and lateral incisors and maxillary lateral incisors.
| No. | Subject Device | Implant System
Compatibility | Implant Diameter (Ø) | Platform Diameter
(Ø) | K number |
|-----|---------------------------------|------------------------------------------|----------------------|--------------------------|----------|
| 1 | s-Clean Link
Abutment Narrow | s-Clean OneQ-SL
Narrow Implant System | 3.3 | 3.3 | K161244 |
s-Clean Link Abutment Narrow is intended for use with the s-Clean OneQ-SL Narrow Fixture according to connector part in the chart. All digitally designed zirconia for use with s-Clean Link Abutment Narrow are intended to be manufactured at a Dentis validated milling center.
Device Description:
The s-Clean Link Abutment Narrow is intended to provide support for customized prosthetic restorations such as crowns and bridges. The s-Clean Link Abutment is composed of a two-piece abutment that is a link abutment at the bottom and a coping (CAD/CAM patient specific superstructure) as the top-half. The submission also includes an abutment fixation screw. The s-Clean Link Abutment are pre-manufactured (stock) abutments, made from a titanium alloy conforming to ASTM F136.
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
The top half of the s-Clean link abutment composed of zirconia is referenced from our previously cleared K222913 submission.
s-Clean Abutment Screw is made of Ti-6Al-4V ELI (ASTM F136) and cleared in K161244.
The diameters of s-Clean Link Abutment Narrow are 4.0 and 4.5mm.
s-Clean Link Abutment Narrow is provided non-sterile and must be sterilized after the cementation of the patientspecific superstructure on the Link Abutment Narrow.
The proposed devices are compatible with the following device:
| Dental Implants | |
|---|---|
| Subject Abutment | s-Clean Link Abutment Narrow |
| Compatible Implants | s-Clean OneQ-SL Narrow Fixture |
| (Knumber) | (K161244) |
| Implant diameter size | Ø3.3 |
| Implant Length | 10, 12 and 14mm |
| Implant Interface Connection Type | Internal connection type / Screw retained |
| Type of Implant-Abutment | Hex/Non Hex |
| Connection |
Raw material cement
• K191122, 3M RelyX Pediatric Resin Modified Glass Ionomer Cement by 3M ESPE Dental Product
The ceramic and cement used for the subject device is identical to the primary predicate. The coping that composes the final abutment should be designed and milled through the CAD/CAM software, at a Dentist validated milling center, according to the prosthetic planning and patient clinical situation. 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 Narrow | |
|---|---|
| Minimum wall thickness | 0.5 |
| Minimum/Maximum Post Height for single- | |
| unit restorations | 4.45 |
| Maximum gingival height in the zirconia | |
| superstructure | 0 |
| Minimum gingival height in the Link | |
| Abutment | 1 |
| Maximum Angulation | 0 |
5
Summaries of Technology Characteristics
The subject device is substantially equivalent to the current cleared devices. They are substantially equivalent in intended use, material 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 | Dentis Co., Ltd |
| Trade Name | s-Clean Link Abutment Narrow | s-Clean Link Abutment |
| 510(k) No. | K230523 | K222913 |
| Classification Name | Endossoeus Dental Implant Abutment | Endossoeus Dental Implant Abutment |
| Product Code | NHA | NHA |
| Class | Class II | Class II |
| Design | Image: dental implant abutment design | Image: dental implant abutment design |
| Base Material | Ti-6Al-4V ELI (ASTM F136) | Ti-6Al-4V ELI (ASTM F136) |
| Diameter (mm) | 4.0 and 4.5 | 4.5 and 4.8 |
| Superstructure | ||
| Angulation | 0 ° | 0 ° |
| 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 | ||
| MRI Safety | Same MR conditional labeling | Same MR conditional labeling |
| Zirconia Superstructure Design Parameters | ||
| Minimum Diameter | ||
| (mm) | 4.0 | 4.5 |
| Minimum Post Wall | ||
| Thickness (mm) | 0.5 | 0.5 |
| Maximum Gingival | ||
| Height in the Zirconia | ||
| superstructure | 0 | 0 |
| Angulation (°) | 0 | 0 |
6
| s-Clean Link Abutment Narrow is intended for use with dental implant as a support for single or multiple tooth prostheses in mandibular central and lateral incisors and maxillary lateral incisors. | | | | | 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. | | | | | | | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|---------------------------------------|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|--------|----------------------------------------|------------------------------------|-----------------------------|------------------------------|----------|
| Indications For Use/
Intended Use | N
o | Subject
Device | Implant System
Compatibility | Implant
Diameter | Platform
Diameter | K number | N
o | Subject
Device | Implant
System
Compatibility | Implant
Diameter
(mm) | Platform
Diameter
(mm) | K number |
| | 1 | s-Clean
Link
Abutment
Narrow | s-Clean OneQ-
SL Narrow
Fixture | Ø3.3 | Ø3.3 | K161244 | 1 | s-Clean
Link
Abutment
Regular | Dentis s-
Clean s-Line | Ø5.8, 6.8
and 7.8 | Ø4.3, 4.5 | K210134 |
| | s-Clean Link Abutment Narrow is intended for use with the s-Clean
OneQ-SL Narrow Fixture according to connector part in the chart. All
digitally designed zirconia for use with s-Clean Link Abutment
Narrow are intended to be manufactured at a Dentis validated milling
center. | | | | | | 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 provided in the chart. All digitally designed
abutment for use with Dentis CAD/CAM Abutments are intended to be
manufactured at a Dentis validated milling center. | | | | | | | | | | | |
| Substantial
Equivalence
Comparison | The subject s-Clean Link Abutment Narrow is substantially equivalent in designs, dimensions, material, superstructure and sterile
method with the identified primary predicate device, K222913. The s-Clean Link Abutment Narrow 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 diameter, 4.0mm of the subject device is different from the predicate device, however, this is due to the difference in dimension
of the implant body.
The Indication for Use of the subject device is also different. While the predicate device is used to support for
single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient, the implant diameter 3.3mm
for the subject device is used to support for single or multiple tooth prostheses mandibular central and lateral incisors and maxillary
lateral incisors.
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
Non-Clinical Testing
Below tests were performed for predicate devices and leveraged for the subject device:
- . End User Sterilization Validation test for s-Clean Link abutment cemented to zirconia top according to ISO 17665-1:2006, 17665-2:2009 and ANSVAAMI ST79:2010 referenced in K222193
- Biocompatibility tests on s-Clean Link abutment according to ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-10:2010 and ISO 10993-11:2017 referenced in K222913
- Cytotoxicity testing on s-Clean Link Abutment cemented to zirconia superstructure according to ISO 10993-5:2009 referenced in K222193
The end user sterilization test was performed for predicate device, K222193 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. K222193 and leveraged for the subject device because both products are manufactured with same materials and manufacturing process. It demonstrates that the subject device is biocompatible and substantial equivalence with the predicate.
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".
MR Environment Condition
Non-clinical worst-case MRI review was performed to evaluate the metallic s-Clean Link Abutment Narrow 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. The subject device and primary predicate device have MR conditional labeling.
Clinical testing was not necessary to establish substantial equivalency of the device.
Conclusion
The s-Clean Link Abutment Narrow 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 Narrow and its predicates are substantially equivalent.