(192 days)
s-Clean Pre-Milled 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 Pre-Milled Abutment is intended for use with the s-Clean SQ-SL Fixtures in the chart. All digitally designed abutments for use with s-Clean Pre-Milled Abutment are intended to be manufactured at a Dentis validated milling center.
Patient-specific abutment is made from titanium alloy conforming to ASTM F136 titanium abutment to be used in fabricating patient-specific abutments. The subject abutments are indicated for cemented or "Screw-and Cement-Retained Prosthesis(SCRP)" restorations. Each patient-specific abutment is individually prescribed by the clinician.
The diameters of patient-specific abutment are 5.8, 6.8mm and two connection designs (Hex, Non-hex).
Patient-Specific Abutment is compatible with following Implant Systems:
Proprietary Name: Dentis s-Clean s-Line
Compatible Implants (K number): K210134
Implant diameter size: 5.8/6.8
Implant Interface Connection Type/Size (mm): Internal Connection type/ 2.5
Type of Implant-Abutment Connection: Hex/Non-Hex
Patient-Specific Abutments are supplied with s-Clean abutment screw and provided non-sterile.
Patient-Specific Abutment design Limitation (Unit :mm):
Model Name: DSCBA10H, DSCBA14H, DSCBA10N, DSCBA14N, DSCBM10H, DSCBM14H, DSCBM10N, DSCBM14N
Range (Diameter): 4.5-6.5
Range (Length): 7.3-17.9
Range (Angle): 0-30°
Materials:
S-Clean Pre-Milled Abutment and S-Clean Abutment Screw is fabricated from Ti-6A1-4V ELI (Conforming to ASTM Standard F136).
The provided text describes a medical device, the "s-Clean Pre-Milled Abutment," and its submission for FDA 510(k) clearance, which is based on demonstrating substantial equivalence to a legally marketed predicate device. This document does not detail acceptance criteria and a study proving device performance in the context of an AI/ML medical device, but rather the non-clinical testing performed for a dental implant abutment.
Therefore, many of the requested fields are not applicable to the information provided in the input, as the study described is a non-clinical, mechanical fatigue test for a physical dental device, not an AI/ML-based diagnostic or prognostic tool.
Here's a breakdown of the relevant information from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Non-Clinical Testing: | Meets Criteria: |
| Fatigue testing according to ISO 14801:2016 for the worst-case scenario. | "The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the predicate device." "The result say that device performance was substantial equivalent." |
| Biocompatibility testing according to ISO 10993-1:2009 (leveraged from predicate device K200099). | "The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the predicate device." |
| End User Sterilization Validation Test Report according to ANSI/AAMI ST79, ISO 17665-1, ISO 17665-2, ISO 11737-1, ISO 11737-2, and ISO 11138-1 (leveraged from predicate device K111364). | "The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the predicate device." |
| Compliance with FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments." | "Non-clinical test data was conducted in accordance with FDA Guidance... and it consisted of testing finished assembled implant/abutment systems of the worst-case scenario, through fatigue testing." "The result say that device performance was substantial equivalent." |
2. Sample size used for the test set and the data provenance
The document states that fatigue tests were performed on the subject device "under the worst case scenario." It does not specify the exact number of samples used for this test. Data provenance is not specified, but it can be inferred that the testing was conducted for the purpose of this 510(k) submission, likely by or for Dentis Co., Ltd.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a physical device testing scenario (fatigue, biocompatibility, sterilization), not a diagnostic or AI/ML device requiring expert ground truth for interpretation or classification.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study requiring human adjudication. The "ground truth" for these tests comes from adherence to established engineering and biological standards.
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
Not applicable. This is a non-clinical evaluation of a physical dental abutment, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For fatigue testing, the ground truth is based on the failure criteria defined by ISO 14801:2016. For biocompatibility, it's based on ISO 10993-1:2009 standards. For sterilization, it's based on ANSI/AAMI ST79, ISO 17665-1, ISO 17665-2, ISO 11737-1, ISO 11737-2, and ISO 11138-1 standards. These are objective, quantifiable physical and biological standards.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device that requires a training set.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized representation of a human figure. The FDA name is written in blue, with the words "U.S. FOOD & DRUG" on the top line and "ADMINISTRATION" on the bottom line.
August 19, 2021
Dentis Co., Ltd. % April Lee Consultant Withus Group Inc 106 Superior Irvine, California 92620
Re: K210362
Trade/Device Name: s-Clean Pre-Milled Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: July 13, 2021 Received: July 19, 2021
Dear April Lee:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Andrew Steen Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210362
Device Name s-Clean Pre-Milled Abutment
Indications for Use (Describe)
s-Clean Pre-Milled 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. | Implant System Compatibility | Implant Diameter (mm) | Platform Diameter (mm) |
|---|---|---|---|
| 1 | s-Clean SQ-SL Fixture | $Ø5.8$ | $Ø4.3$ |
| 2 | s-Clean SQ-SL Fixture | $Ø6.8$ | $Ø4.5$ |
s-Clean Pre-Milled Abutment is intended for use with the s-Clean SQ-SL Fixtures in the chart. All digitally designed abutments for use with s-Clean Pre-Milled 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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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 Pre-Milled Abutment
- Common Name: Dental Abutment System
- Classification Name: Endosseous dental implant abutment
- Product Code: NHA
- Panel: Dental
- Regulation Number: 872.3630
- Device Class: Class II ●
- Date prepared: 08/18/2021
Predicate Devices:
Primary Predicate K181037, DIO CAD/CAM Abutment by DIO CORPORATION
Reference Device K171694, s-Clean TiN Coating Abutment by Dentis Co., Ltd. K111364, HAPTITE Coating Implant System K200099, s-Clean SQ-SL Implant System Mini
Indication for Use:
s-Clean Pre-Milled 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. | Implant System Compatibility | Implant Diameter (mm) | Platform Diameter (mm) |
|---|---|---|---|
| 1 | s-Clean SQ-SL Fixture | Ø5.8 | Ø4.3 |
| 2 | Ø6.8 | Ø4.5 |
s-Clean Pre-Milled Abutment is intended for use with the s-Clean SQ-SL Fixtures in the chart. All digitally designed abutments for use with s-Clean Pre-Milled 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
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Device Description:
Patient-specific abutment is made from titanium alloy conforming to ASTM F136 titanium abutment to be used in fabricating patient-specific abutments. The subject abutments are indicated for cemented or "Screw-and Cement-Retained Prosthesis(SCRP)" restorations. Each patient-specific abutment is individually prescribed by the clinician.
The diameters of patient-specific abutment are 5.8, 6.8mm and two connection designs (Hex, Non-hex).
Patient-Specific Abutment is compatible with following Implant Systems:
| Proprietary Name | Dentis s-Clean s-Line |
|---|---|
| Compatible Implants (K number) | K210134 |
| Implant diameter size | 5.8/6.8 |
| Implant Interface Connection Type/Size (mm) | Internal Connection type/ 2.5 |
| Type of Implant-Abutment Connection | Hex/Non-Hex |
Patient-Specific Abutments are supplied with s-Clean abutment screw and provided non-sterile.
| Patient-Specific Abutment design Limitation (Unit :mm) | |||
|---|---|---|---|
| Model Name | Range (Diameter) | Range (Length) | Range (Angle) |
| DSCBA10H | 4.5-6.5 | 7.3-17.9 | 0-30° |
| DSCBA14H | |||
| DSCBA10N | |||
| DSCBA14N | |||
| DSCBM10H | 4.5-6.5 | 7.3-17.9 | 0-30° |
| DSCBM14H | |||
| DSCBM10N | |||
| DSCBM14N |
Materials:
- . S-Clean Pre-Milled Abutment and S-Clean Abutment Screw is fabricated from Ti-6A1-4V ELI (Conforming to ASTM Standard F136).
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K210362
Summaries of Technology Characteristics
The subject device is substantially equivalent to the current cleared devices. They are substantialy 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 Device | |||||||
|---|---|---|---|---|---|---|---|---|
| Applicant | Dentis Co., Ltd. | DIO Corporation | ||||||
| Trade Name | s-Clean Pre-Milled Abutment | DIO CAM/CAM Abutment | ||||||
| 510(k) No. | K210362 | K181037 | ||||||
| Classification Name | Endosseous Dental Implant, Abutment (872.3630) | Endosseous Dental Implant, Abutment (872.3630) | ||||||
| Product Code | NHA | NHA | ||||||
| Class | II | II | ||||||
| Material | Ti-6AL-4V ELI (ASTM F136) | Ti-6AL-4V ELI (ASTM F136) | ||||||
| Diameter (mm) | CAD/CAM Patient-Specific Abutment:5.8/6.8 | CAD/CAM Patient-Specific Abutment:3.0/3.3/3.8/4.0/4.5/5.0/5.5/6.0/6.5/7.0 | ||||||
| Sterile | Steam Sterilization by user(Provided Non-Sterile) | Steam Sterilization by user(Provided Non-Sterile) | ||||||
| Type of Retention | Screw-retained or cement retained | Screw-retained or cement retained | ||||||
| Abutment Seat | Sits on Taper | Sits on Taper | ||||||
| Anatomical Site | Oral Cavity | Oral Cavity | ||||||
| Constructions | Machined | Machined | ||||||
| s-Clean Pre-Milled 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. | |||||||
| Implant System Compatibility | Implant Diameter (mm) | Platform Diameter (mm) | Implant System Compatibility | Implant Diameter (mm) | Platform Diameter (mm) | |||
| Indications For Use/Intended Use | 1 | s-Clean SQ-SL Fixture | Ø5.8 | Ø4.3 | UF(II) Narrow Implant System | 3.0/3.3 | 3.0/3.3 | |
| 2 | Ø6.8 | Ø4.5 | UF Sub merged 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 Pre-Milled Abutment is intended for use with the s-Clean SQ-SL Fixtures in the chart. All digitally designed abutments for use with s-Clean Pre-Milled 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 |
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K210362
| Patient specific abutment is intended for use with the UF implant systemsprovided in the chart. All digitally designed abutments for use with DIOCAD/CAM Abutments are intended to be manufactured at a DIOCorporation validated milling center. | |
|---|---|
| SubstantialEquivalenceComparison | The subject patient specific abutment is substantially equivalent in designs, dimensions, material, indications, abutment seat, screw seat,anatomical site, connection, and technological characteristics with the identified primary predicate device. The patient specific abutmentis similar in fundamental scientific technology to the predicate device in that they all have been designed, manufactured and tested incompliance with FDA's Class II special controls guidance document root-food endosseous dental implants and endosseous dentalimplant abutments.The Indications for Use of the subject and primary predicate device are identical other than the compatible implant bodies. Thisdifference is mitigated by fatigue testing, and identification of reference device for compatible implant bodies. Both the predicate andsubject devices are intended to be milled into patient specific abutments using CAD/CAM technology under the manufacturing controlof the sponsor. Any differences in technology characteristics are accompanied by information that demonstrated the device issubstantially equivalent. |
| Subject Device | Reference Device | |
|---|---|---|
| 510(k) No. | K210362 | K171694 |
| Trade Name | s-Clean Pre-Milled Abutment | s-Clean TiN Coating Abutments |
| Manufacturer | Dentis Co., Ltd | Dentis Co., Ltd |
| Product Name | s-Clean Abutment Screw | s-Clean Abutment Screw |
| Diameter | $ø2.32$ | $ø2.32$ |
| Length | 9.4 | 9.8 |
| Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
| Sterility | End-User Sterile | End-User Sterile |
| Brief Comparison | The Subject Device and Reference Device(K171694) has same manufacturer, Diameter, Indication for use, material and Sterility. Onlylength is different but this difference is not important factor for performance. Both devices are substantially equivalent. |
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Non-Clinical Testing
The subject device was tested to evaluate its substantial equivalence according to the following standards.
-
Fatigue Tests on subject device under the worst case scenario according to ISO 14801:2016 .
Below tests were performed for predicate devices and leveraged for the subject device: -
Biocompatibility testing according to ISO 10993-1:2009 abutments referenced in K200099 ●
-
. End User Sterilization Validation Test Report according to ANSI/AAMI ST79, ISO 17665-1, ISO 17665-2, ISO 11737-1, ISO 11737-2, and ISO 11138-1 referenced in K111364
The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the predicate device.
Non-clinical test data was conducted in accordance with FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments", and it consisted of testing finished assembled implant/abutment systems of the worst-case scenario, through fatigue testing. The result say that device performance was substantial equivalent.
Clinical testing was not necessary to establish substantial equivalency of the device.
Conclusion
The s-Clean Pre-Milled 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 devices. Therefore, the s-Clean Pre-Milled Abutment and its predicates are substantially equivalent.
§ 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.)