(199 days)
Dentis s-Clean Regular Abutment 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 two stage surgical procedures. This system is intended for delayed loading.
Dentis s-Clean Regular Abutment is intended for use as an aid in prosthetic restoration. It consists of Abutments, components, and Abutment screws.
Here's an analysis of the provided text regarding acceptance criteria and supporting studies. It's important to note that this document is a 510(k) summary for a dental implant abutment, and as such, it focuses on demonstrating "substantial equivalence" to existing cleared devices rather than establishing novel safety and effectiveness criteria from scratch. Therefore, the "acceptance criteria" here are largely implied by the equivalence to predicate devices and adherence to relevant standards.
General Observation: The document primarily focuses on demonstrating substantial equivalence (SE) based on comparing the subject device's (Dentis s-Clean Regular Abutment) technical characteristics, materials, and intended use to various predicate and reference devices. The "performance" being evaluated is largely through compliance with international standards and leveraging prior testing on similar devices. There isn't a direct "device performance" in terms of clinical outcomes with AI assistance or human reader improvement, as this is a physical medical device (dental abutment).
1. A table of acceptance criteria and the reported device performance
Given the nature of the device (dental abutment) and the submission type (510(k) for substantial equivalence), the "acceptance criteria" are predominantly about meeting material specifications, standardized mechanical testing, and demonstrating equivalence in design and intended use to legally marketed predicate devices. The "reported device performance" is largely the successful completion of these tests or the justification for leveraging prior testing.
| Acceptance Criterion (Implied by Standards & Equivalence) | Reported Device Performance |
|---|---|
| Mechanical Performance: - Resistance to fatigue under worst-case scenario. (ISO 14801:2016) | - "Fatigue Testing under the worst-case scenario according to ISO 14801:2016" was performed on the subject device and "results of the above tests have met the criteria of the standards." |
| Sterilization Efficacy (for SAVE Wide Cap): - Validation of sterilization process. (ISO 11137-1,2,3) | - "Sterilization Validation Test for SAVE Wide Cap according to ISO 11137-1.2,3" was "performed for predicate devices and leveraged for the subject device." Implied to have met criteria. |
| Shelf Life (for SAVE Wide Cap): - Confirmation of product stability over time. (ASTM F1980) | - "Shelf Life Test for SAVE Wide Cap according to ASTM F1980 referenced in K171027" was "performed for predicate devices and leveraged for the subject device." Implied to have met criteria. |
| End User Sterilization Efficacy (for Abutments): - Validation of end-user sterilization methods for various materials. (ANSI/AAMI ST79, ISO 17665-1,-2, ISO 11737-1,-2, ISO 11138-1) | - "End User Sterilization Validation Test Report for Abutments made with Ti-6Al-4V ELI according to [standards] referenced in K111364" was "performed for predicate devices and leveraged for the subject device." - "End User Sterilization Validation Test Report for Abutments made with PEEK, POM and CP Titanium Grade 4 according to [standards]" was performed. - All implied to have met criteria. |
| Biocompatibility: - Safety concerning biological interaction with human tissue. (ISO 10993-1:2009) | - "Biocompatibility testing for subject Abutments according to ISO 10993-1:2009 referenced in K171027, K171694, and K222913" was performed on the "predicate device and leveraged for the subject device because both products are manufactured with same materials and manufacturing process." - "Demonstrates that the subject device is biocompatible and substantial equivalence with the predicate." |
| Design and Material Equivalence: - Comparison of dimensions, materials, and general design to predicate devices. | - Detailed comparison tables are provided for each component of the Dentis s-Clean Regular Abutment against specific predicate/reference devices, showing "same indications for use," similar or same dimensions (with differences justified as not impacting performance), and identical materials where applicable. - Example for s-Clean Couple Abutment: "Subject Device and Primary Predicate(K171027) have same indications for use, similar sizes...material, and sterilization method. Both devices are substantial equivalent." |
| Intended Use Equivalence: - The subject device's intended use matches that of predicate devices. | - "This system has the same intended use and fundamental scientific technology as its predicate devices." The Indications for Use statement is provided and implicitly compared to predicate devices. |
| Manufacturing Process / Facility Equivalence: - For leveraged testing, assurance that processes are similar/identical. | - For leveraged end-user sterilization tests: "because the product category, material, manufacturing process, facility, and packaging of the both products are exactly same." |
2. Sample size used for the test set and the data provenance
The document specifies "Fatigue Testing under the worst-case scenario according to ISO 14801:2016" was performed on the subject device. However, it does not specify the sample size used for this specific test item.
For the other tests (Sterilization Validation, Shelf Life, End User Sterilization Validation, Biocompatibility), the data provenance is that they were "performed for predicate devices and leveraged for the subject device" or "conducted on the predicate device and leveraged."
- Sample Size: Not explicitly stated for any of the tests.
- Data Provenance: Retrospective (leveraged from previously cleared predicate/reference devices) and some prospective (Fatigue Testing on the subject device). The country of origin of the data is not specified, but the manufacturer is Dentis Co., Ltd. (Korea) and the US correspondent is Withus Group Inc. (USA). The tests were presumably conducted in facilities capable of meeting the cited international standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to this type of device submission. This is a physical dental implant component, not an AI/software device that requires expert adjudication for ground truth establishment. The "ground truth" here is compliance with engineering standards and material specifications, verified through laboratory testing.
4. Adjudication method for the test set
This question is not applicable. There is no human adjudication process described for the engineering tests performed on a physical dental abutment. The outcome of the tests (e.g., fatigue strength, material composition) is objectively measured against a standard.
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
This question is not applicable. This device is a physical dental abutment, not an imaging or diagnostic AI device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. This device is a physical dental abutment, not an algorithm or software.
7. The type of ground truth used
The "ground truth" for the performance of this dental abutment is based on:
- Engineering Standards and Specifications: Adherence to international standards like ISO 14801 (fatigue), ISO 11137 (sterilization), ASTM F1980 (shelf life), ISO 10993-1 (biocompatibility), and material specifications (e.g., ASTM F136 for Ti-6Al-4V ELI).
- Material Composition Analysis: Ensuring materials match specified standards (e.g., Ti-6Al-4V ELI, Pure Titanium Gr4, PEEK, POM).
- Dimensional Accuracy: Ensuring dimensions are within acceptable tolerances.
- Demonstrated Performance of Predicate Devices: Relying on the established safety and effectiveness of legally marketed predicate devices through showing substantial equivalence in design, materials, and intended use.
8. The sample size for the training set
This question is not applicable. This is a physical device, not an AI/machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
This question is not applicable. Since there is no training set, there is no ground truth established for it.
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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: the Department of Health & Human Services logo on the left and the FDA acronym followed by the full name of the agency on the right. The Department of Health & Human Services logo is a stylized depiction of an eagle. The FDA acronym and the agency's full name are in blue.
Dentis Co., Ltd % April Lee Consultant Withus Group Inc 106 Superior Irvine, California 92620
Re: K230126
Trade/Device Name: Dentis s-Clean Regular Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: July 5, 2023 Received: July 6, 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.
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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.
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
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Indications for Use
510(k) Number (if known) K230126
Device Name Dentis s-Clean Regular Abutment
Indications for Use (Describe)
Dentis s-Clean Regular Abutment is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures. This system is intended for delayed loading.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(K) Summary
Submitter
Dentis Co., Ltd. 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
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
Device Information
- Trade Name: Dentis s-Clean Regular Abutment
- Common Name: Dental Implant Abutment
- Classification Name: Abutment, Implant, Dental, Endosseous ●
- Product Code: NHA
- Panel: Dental ●
- Regulation Number: 872.3630
- Device Class: Class II
- Date Prepared: 08/04/2023
Predicate Devices:
The subject device is substantially equivalent to the following predicate devices:
Primary Predicate
- K171027, Dentis Dental Implant System manufactured by Dentis Co., Ltd.
Reference devices
- K082843, Dentis Dental Implant System manufactured by Dentis Co., Ltd
- K111364, HAPTITE COATING IMPLANT SYSTEM by Dentis Co., Ltd.
- K150344, Dentis Dental Implant System manufactured by Dentis Co., Ltd.
- K161689, OSSTEM Implant System manufactured by Osstem Implant Co., Ltd ●
- K171694, s-Clean TiN Coating Abutment manufactured by Dentis Co., Ltd.
- K210134, Dentis s-Clean s-Line manufactured by Dentis Co., Ltd.
- K210826, Healing Abutment, Cover Screw manufactured by Megagen Implant Co., Ltd. ●
- . K222913, s-Clean Link Abutment by Dentis Co., Ltd.
Indication for Use:
Dentis s-Clean Regular Abutment 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 two stage surgical procedures. This system is intended for delayed loading.
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Device Description:
Dentis s-Clean Regular Abutment is intended for use as an aid in prosthetic restoration. It consists of Abutments, components, and Abutment screws.
Dentis s-Clean Regular Abutment is compatible with the fixtures below:
| K number | Device Name | Dimension Ranges |
|---|---|---|
| K192688 | s-Clean SQ-SL Fixture | Ø5.8, 6.8 and 7.8 (D) x 7.0, 7.5, 9.5, 11.4 and 1 |
Tolerance of dimension shall be within ± 1% range.
The dimensions of abutments are as following:
| No. | Device Name | Dimension Ranges | Angulation |
|---|---|---|---|
| 1 | s-Clean Couple Abutment | Ø4.5, 5.5 and 6.5 (D) x 7.3, 7.44, 7.8, 7.94, 8.3, 8.44, 8.8,8.94, 9.8, 9.94, 10.8 10.94, 11.8 and 11.94mm (L) | 0° |
| 2 | s-Clean Angled Abutment | Ø4.5, 5.5 and 6.5 (D) x 9.4, 9.54, 10.4, 10.54, 12.4 and12.54mm (L) | 15° and 25° |
| 3 | s-Clean Temporary Abutment | Ø4.5 and 5.5 (D) x 15.4 and 15.54mm (L) | 0° |
| 4 | s-Clean MU AngledAbutment | Ø4.8 (D) x 6.1mm (L) | 17° |
| 5 | s-Clean MU Healing Cap | Ø5.8 and 6.8 (D) x 4.1mm (L) | 0° |
| 6 | s-Clean Multi Use CopingHealing Cap | Ø5.2, 5.9 and 6.9 (D) x 6.1mm (L) | 0° |
| 7 | O-Ring Abutment RetainerCap | Ø5.15 (D) x 4.3mm (L) | 0° |
| 8 | O-Ring Abutment O-Ring | Ø4.4 and 4.6 (D) x 1.5mm (L) | 0° |
| 9 | SAVE Wide Cap | Ø6.0, 7.0 and 8.0 (D) x 7.7, 8.6 and 9.6mm (L) | 0° |
The Abutments have below featured:
| Name | Uses | Surface | Connection |
|---|---|---|---|
| s-Clean Couple Abutment | The Abutment is connected with fixture and itsupports prosthesis which restores toothfunction. | Non | |
| s-Clean Angled Abutment | Non | ||
| s-Clean Temporary Abutment | This Abutment is used for fabricatingprovisional restoration | Non | Internal Hex2.5 |
| s-Clean MU Angled Abutment | MU Abutment is useful for various angulationimplanted fixture and gingival angulation.MU Angled Abutment is for multi-unit only. | Non | |
| s-Clean MU Healing Cap | This Healing cap is used for protect theabutment and reduce patient discomfort. | Non | Screwretained |
| s-Clean Multi Use Coping HealingCap | Non | N/A | |
| O-Ring Abutment Retainer Cap | Non | N/A | |
| O-Ring Abutment O-Ring | This O-Ring Abutment is used for overdenture | Non | N/A |
| SAVE Wide Cap | SAVE Wide Cap is intended for use as an aid inprosthetic rehabilitation. | Non | Screwretained |
Tolerance of dimension for Abutments shall be within ± 1% range.
Dentis s-Clean Regular Abutment is provided non-sterilized. The SAVE Wide Cap is provided sterilized.
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Materials:
- s-Clean Couple Abutment, s-Clean Angled Abutment, s-Clean MU Angled Abutment, s-Clean MU ● Healing Cap and SAVE Wide Cap are fabricated from Ti-6A1-4V of ASTM F136
- s-Clean Temporary Abutment and O-Ring Abutment Retainer Cap are fabricated from Pure Titanium . for ASTM F67
- . s-Clean Temporary Abutment is fabricated form Polyetheretherketone for ASTM F2026
- s-Clean Multi Use Coping Healing Cap is fabricated from Polyoxymethylene(POM) for ASTM F1855
Summaries of Technological Characteristics & Substantial Equivalence Discussion
| Subject Device | Primary Predicate | |
|---|---|---|
| K number | K230126 | K171027 |
| Manufacturer | Dentis Co., Ltd | Dentis Co., Ltd |
| Trade Name | Dentis s-Clean Regular Abutment | Dentis Dental Implant System |
| Product Name | s-Clean Couple Abutment | s-Clean Couple Abutment |
| Design | Image: s-Clean Couple Abutment design | Image: s-Clean Couple Abutment design |
| Diameter | Ø4.5, 5.5 and 6.5 | Ø4.0, 4.5, 4.8, 5.5, 6.0 and Ø6.5 |
| Gingival Height | 0.8, 1.3, 1.8, 2.3, 3.3, 4.3 and 5.3mm | 0.8, 1.3, 1.8, 2.3, 3.3, 4.3 and 5.3mm |
| Length | 7.3, 7.44, 7.8, 7.94, 8.3, 8.44, 8.8,8.94, 9.8, 9.94, 10.8 10.94, 11.8 and11.94mm | 7.3, 7.44, 7.8, 7.94, 8.3, 8.44, 8.8, 8.94, 9.3, 9.44,9.8, 9.94, 10.3, 10.4, 10.44, 10.8, 10.9, 10.94,11.3, 11.4, 11.44, 11.8, 11.9, 11.94, 12.3, 12.44,12.8, 12.9, 12.94, 13.3, 13.44, 13.8, 13.9, 13.94,14.8, 14.9 and 14.94mm |
| Material | Ti-6Al-4V ELI(ASTM F136) | Ti-6Al-4V ELI(ASTM F136) |
| Sterilization | End User Sterilization | |
| Comparison | Subject Device and Primary Predicate(K171027) have same indications for use, similarsizes such as diameters, gingival heights, and lengths, material, and sterilization method.Both devices are substantial equivalent. |
Dentis s-Clean Couple Abutment
s-Clean Angled Abutment
| Subject Device | Reference Device | |
|---|---|---|
| K number | K230126 | K082843 |
| Manufacturer | Dentis Co., Ltd | Dentis Co., Ltd |
| Trade Name | Dentis s-Clean Regular Abutment | s-Clean TiN Coating Abutment |
| Product Name | s-Clean Angled Abutment | s-Clean Angled Abutment |
| Design | Image: Subject Device Design | Image: Reference Device Design |
| Diameter | Ø4.5, 5.5 and Ø6.5 | Ø4.5, 5.0, 5.5 and Ø6.5 |
| Gingival Height | 0.8, 1.8 and 3.8mm | 1.8 and 3.8mm |
| Length | 9.4, 9.54, 10.4, 10.54, 12.4 and12.54mm | 10.54 and 12.54mm |
| Angulation | 15° and 25° | 15° and 25° |
| Material | Ti-6Al-4V ELI(ASTM F136) | Ti-6Al-4V ELI(ASTM F136) |
| Sterilization | End User Sterilization | End User Sterilization |
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| Comparison | Subject Device and Reference Device (K082843) have same indications for use, size as diameter, gingival height, angulation, material, and sterilization method. The lengths of the devices are different, but this difference is not an important factor for the device performance. Thus, both devices are substantial equivalent. |
|---|---|
| ------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
s-Clean Temporary Abutment
| Subject Device | Primary Predicate | |
|---|---|---|
| K number | K230126 | K171027 |
| Manufacturer | Dentis Co., Ltd | Dentis Co., Ltd |
| Trade Name | Dentis s-Clean Regular Abutment | Dentis Dental Implant System |
| Product Name | s-Clean Temporary Abutment | s-Clean Temporary Abutment |
| Design | Image: Subject Device Designs | Image: Primary Predicate Designs |
| Diameter | Ø4.5 and Ø 5.5 | Ø4.5, 4.8, 5.5, 6.0 and Ø6.5 |
| Length | 15.4 and 15.54mm | 13.4 and 13.54mm |
| Material | Pure Titanium Gr4 (ASFM F67) / PEEK | Pure Titanium Gr4 (ASFM F67) / PEEK |
| Sterilization | End User Sterilization | End User Sterilization |
| Comparison | Subject Device and Primary Predicate (K171027) have same indications for use, diameters, material, and sterilization method. Difference is only length, however, this difference is not importance factor for this product because this is used temporary. Both devices are substantial equivalent. |
s-Clean MU Angled Abutment
| Subject Device | Reference Device | |
|---|---|---|
| K number | K230126 | K150344 |
| Manufacturer | Dentis Co., Ltd | Dentis Co., Ltd |
| Trade Name | Dentis s-Clean Regular Abutment | Dentis Dental Implant System |
| Product Name | s-Clean MU Angled Abutment | MU Angled Abutment |
| Design | Image: Subject Device Design | Image: Reference Device Design |
| Diameter | Ø4.8 | Ø4.8 |
| Length | 6.1mm | 6.08, 8.08, 6.69 and 8.69mm |
| Angulation | 17° | 17° and 30 ° |
| Material | Ti-6Al-4V ELI (ASTM F136) | Ti-6Al-4V ELI (ASTM F136) |
| Sterilization | End User Sterilization | End User Sterilization |
| Comparison | Subject Device and Reference Device (K150344) have same indications, diameter, length,angulation, material, and sterilization method. Thus, both devices are substantial equivalent. |
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s-Clean MU Healing Cap
| Subject Device | Reference Device | |
|---|---|---|
| K number | K230126 | K210134 |
| Manufacturer | Dentis Co., Ltd | Dentis Co., Ltd |
| Trade Name | Dentis s-Clean Regular Abutment | Dentis s-Clean s-Line |
| Product Name | s-Clean MU Healing Cap | s-Clean MU Healing Cap |
| Design | Image: Subject Device Design | Image: Reference Device Design |
| Head Diameter | $Ø$ 5.8 and 6.8 | $Ø$ 4.8 |
| Length | 4.1mm | 4.1mm |
| Material | Ti-6Al-4V ELI (ASTM F136) | Ti-6Al-4V ELI (ASTM F136) |
| Sterilization | Steam sterilization by User | Steam sterilization by User |
| Comparison | Subject Device and Reference Device (K150344) have same indications for use andmaterial. The diameter and length are different but this difference is not an important factorfor the device performance. Thus, both devices are substantial equivalent. |
s-Clean Multi Use Coping Healing Cap
| Subject Device | Reference Device | |
|---|---|---|
| K number | K230126 | K171694 |
| Manufacturer | Dentis Co., Ltd | Dentis Co., Ltd |
| Trade Name | Dentis s-Clean Regular Abutment | s-Clean TiN Coating Abutments |
| Product Name | s-Clean Multi Use Coping Healing Cap | Sole Healing Cap |
| Design | Image: Subject Device Design | Image: Reference Device Design |
| Head Diameter | $Ø$ 5.2, 5.9 and 6.9 | $Ø$ 4.6, 5.1, 5.9, 6.3, 6.8 and 6.9 |
| Length | 6.1mm | 6.7, 7.5 and 9.0mm |
| Material | POM | POM |
| Sterilization | End User Sterilization | End User Sterilization |
| Comparison | Subject Device and Reference Device (K171694) have same indications for use and material. The diameter and length are different but this difference is not an important factor for the device performance. Thus, both devices are substantial equivalent. |
O-Ring Abutment Retainer Cap
| Subject Device | Reference Device | |
|---|---|---|
| K number | K230126 | K161689 |
| Manufacturer | Dentis Co., Ltd | Osstem Implant Co., Ltd |
| Trade Name | Dentis s-Clean Regular Abutment | Osstem Abutment System-Abutment |
| Product Name | O-Ring Abutment Retainer Cap | O-ring Retainer Cap Set |
| Design | Image: Subject Device Design | Image: Reference Device Design |
| Head Diameter | Ø5.15 | Ø5.0 |
| Length | 4.3mm | 3.9mm |
| Material | Pure Titanium Gr4 (ASTM F136) | Titanium |
| Sterilization | End User Sterilization | End User Sterilization |
| Comparison | Subject Device and Reference Device (K161689) have same indications for use, similarsizes and material. The diameter and length are slightly different, but this difference is notan important factor for the device performance. Both devices are substantial equivalent. |
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| Subject Device | Reference Device | |
|---|---|---|
| K number | K230126 | K161689 |
| Manufacturer | Dentis Co., Ltd | Osstem Implant Co., Ltd |
| Trade Name | Dentis s-Clean Regular Abutment | Osstem Abutment System-Abutment |
| Product Name | O-Ring Abutment O-Ring | O-ring Retainer Cap Set |
| Design | Image: Red O-ring | Image: Yellow O-ring |
| Diameter | Ø4.4 and 4.6 | Ø4.6 |
| Length | 1.5mm | 1.5 mm |
| Material | Silicon | NBR(Acrylonitrile & Butadiene Polymer) |
| Sterilization | End User Sterilization | End User Sterilization |
| Comparison | The Subject Device and Reference Device (K161689) have same indications for use,length, and sterilization method. The diameter and material are different but both devicesare not patient contact, and it is not important factor to the device performance. The subjectdevice is substantial equivalent |
O-Ring Abutment O-Ring
SAVE Wide Cap
| Subject Device | Reference Device | |
|---|---|---|
| K number | K230126 | K210826 |
| Manufacturer | Dentis Co., Ltd | MegaGen Implant Co., Ltd. |
| Trade Name | Dentis s-Clean Regular Abutment | Healing Abutment, Cover Screw |
| Product Name | SAVE Wide Cap | Cover Screw |
| Design | Image: Subject Device Design | Image: Reference Device Design |
| Diameter | Ø6.0, 7.0 and 8.0 | Ø6.0 |
| Length | 7.7, 8.6 and 9.6mm | 7.2~8.3mm |
| Material | Ti-6Al-4V ELI (ASTM F136) | Ti-6Al-4V ELI (ASTM F136) |
| Sterilization | Gamma Sterilization | Gamma Sterilization |
| Shelf Life | 8years | 5years |
| Comparison | Subject Device and Reference Device (K210826) have same indications for use andmaterial. The diameter and length are different, but this difference is not important factorsfor the device performance. Both devices are substantial equivalent |
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Non-Clinical Test Data
Below tests were performed on subject device:
-
Fatigue Testing under the worst-case scenario according to ISO 14801:2016 ●
Below tests were performed for predicate devices and leveraged for the subject device: -
Sterilization Validation Test for SAVE Wide Cap according to ISO 11137-1.2,3 .
-
. Shelf Life Test for SAVE Wide Cap according to ASTM F1980 referenced in K171027
-
. End User Sterilization Validation Test Report for Abutments made with Ti-6Al-4V ELI according to ANSVAAMI ST79, ISO 17665-1,-2, ISO 11737-1,-2, and ISO 11138-1 referenced in K111364
-
End User Sterilization Validation Test Report for Abutments made with PEEK, POM and CP Titanium Grade 4 according to ANSI/AAMI ST79, ISO 17665-1,-2, ISO 11737-1,-2, and ISO 11138-1
-
. Biocompatibility testing for subject Abutments according to ISO 10993-1:2009 referenced in K171027, K171694, and K222913
The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the predicate device.
Gamma sterilization test was performed for our other device. Healing Abutment (DSHZ7890C) as test specimen and leveraged for the subject device because material, manufacturing process, sterilization and packaging of both products are exactly same.
The end user sterilization test was performed for the predicate device K171027 and reference device K111364 and leveraged for the subject device because the product category, material, manufacturing process, facility, and packaging of the both products are exactly same.
For other subject devices made with other materials as POM, PEEK and Pure Titanium Gr4, the end user sterilization validation reports are provided.
The Biocompatibility Test was conducted on the predicate device 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.
The non-clinical testing results demonstrate that the subject device is substantially equivalent to the predicate device.
Conclusion
Dentis s-Clean Regular 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, s-Clean Regular 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.)