(617 days)
The INNO SLA Submerged Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw-retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.
The INNO SLA Submerged Implant System offers Healing Abutment (Type A and Type B), Angulated Abutment, Temporary Abutment, Sonator S Abutment, Sonator A Abutment, and Screws. These components are used with the fixtures and cover screws cleared under K132242.
The provided text is a 510(k) summary for the INNO SLA Submerged Implant System. It describes the device, its intended use, and argues for its substantial equivalence to previously cleared predicate devices.
However, the document does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria, particularly in the context of an AI/ML-driven device performance study. The device described, the "INNO SLA Submerged Implant System," is a physical dental implant system and not an AI/ML-based medical device. Therefore, the questions related to AI/ML device performance (like sample size for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance) are not applicable to this document.
The document does mention "Non-Clinical Testing" which includes:
- Surface Modification: Leveraging specifications and processes from a predicate device (K132242) for TiN coating.
- Cytotoxicity Testing: Performed on representative abutments with TiN coating according to ANSI/AAMI/ISO 10993-5 and ISO 10993-12. This type of testing ensures the material is not harmful to cells.
- Mechanical performance testing: Conducted according to ISO 14801. This test establishes the fatigue limit to ensure structural integrity and sufficient strength for intended use. The "worst-case scenario" was chosen based on FDA Guidance.
- End-user sterility validation: Conducted according to ISO 17665-1 and ISO 17665-2 for a prior clearance (K132242) and leveraged for the subject devices.
These tests are standard for physical medical devices and confirm material compatibility, mechanical robustness, and effective sterilization, which are relevant "acceptance criteria" for such devices. The document explicitly states that the mechanical performance test demonstrated "sufficient strength for their intended use and are substantially equivalent to predicate devices with regard to mechanical performance."
In summary, the requested information regarding AI/ML device performance cannot be extracted from this document because it pertains to a physical dental implant system, not an AI/ML system.
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Cowellmedi Co., Ltd. % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA. Inc. 1150 Roosevelt STE 200 Irvine, California 92620
Re: K201323
Trade/Device Name: INNO SLA Submerged Implant System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: December 21, 2021 Received: December 23, 2021
Dear Priscilla Chung:
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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542 of the Act); 21 CFR 1000-1050.
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-
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 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) K201323
Device Name INNO SLA Submerged Implant System
Indications for Use (Describe)
The INNO SLA Submerged Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.
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 (K201323)
This summary of 510(K) information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: 1/24/2022
1. Submitter
Cowellmedi Co., Ltd. 48, Hakgam-daero 221beon-gil, Sasang-gu, Busan, 46986, Republic of Korea
2. U.S Agent/Contact Person
Priscilla Chung LK Consulting Group USA, Inc. 1150 Roosevelt STE 200, Irvine CA 92620 Phone: 714.202.5789 Fax: 714-409-3357 Email: juhee.c(@lkconsultinggroup.com
3. Device
- Trade Name: INNO SLA Submerged Implant System ●
- Common Name: Dental Implant System
- Classification Name: Endosseous Dental Implant
- Product Code: NHA
- . Classification regulation: 21CFR872.3630
4. Predicate Device:
- Primary Predicate Device: INNO SLA Submerged Implant System by Cowellmedi Co., Ltd. (K132242)
- . Reference Predicate Device: Locator Implant Anchor Abutment for Endosseous Dental Implant by Zest Anchors, Inc. (K072878)
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5. Description:
The INNO SLA Submerged Implant System offers the following components. The components below are used with the fixtures and the cover screws that were cleared under K132242.
| No | Component | |||
|---|---|---|---|---|
| 1 | Healing AbutmentType AØ7.5 x 10.7mmØ 8.5 x 10.7 mmØ 9.5 x 10.7mm | |||
| 2 | Type BØ 6.5 x 5.9, 6.9, 7.9, 8.9, 9.9, 11.9 mmØ 7.5 x 5.9, 6.9, 7.9, 8.9, 9.9, 11.9 mmØ 8.0 x 5.9, 6.9, 7.9, 8.9, 9.9, 11.9 mmØ 8.5 x 5.9, 6.9, 7.9, 8.9, 9.9, 11.9 mmØ 9.5 x 5.9, 6.9, 7.9, 8.9, 9.9, 11.9 mm | |||
| 3 | Angulated AbutmentØ 4.5 x 11.9, 12.9, 13.9, 14.9mmØ 4.8 x 9.4, 10.4, 11.4mmØ 5.5 x 11.9, 12.9, 13.9, 14.9mm | |||
| 5 | Temporary AbutmentØ 4.5 x 13.65,13.9mm | |||
| 6 | Sonator S AbutmentØ 3.87 x 8.3, 9.3, 10.3, 11.3, 12.3, 13.3mm | |||
| 7 | Sonator A AbutmentØ 3.87 x 7.15, 8.7mm | |||
| 8 | ScrewØ 2.15 x 6.5, 7.5, 8.5mmØ 2.2 x 7.8, 8.8, 9.8mmØ 2.28 x 5mmØ 2.45 x 8.5mm |
6. Indication for use:
The INNO SLA Submerged Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw-retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.
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7. Basis for Substantial Equivalence
Substantial Equivalence Discussion
The INNO SLA Submerged Implant System is substantially equivalent to the predicate devices in terms of intended use and technical characteristics. They are made of the same material and have similar design. There are slight differences mostly in abutment size options, however, it is very minor not affecting substantial equivalence. We have performed the fatigue test to make sure the differences do not raise an issue in safety and effectiveness and the test result of the test supported substantial equivalence. Based on the information and test results provided in submission, we conclude that the subject device is substantially equivalent to the predicate devices.
Comparison Chart
| Subject Device | Predicate Device | ||
|---|---|---|---|
| 510(k) Number | K201323 | K132242 | |
| Device Name | Healing Abutment forINNO SLA Submerged ImplantSystem | Healing Abutment forINNO SLA Submerged ImplantSystem | Remark |
| Manufacturer | Cowellmedi Co., Ltd. | Cowellmedi Co., Ltd. | |
| Indications forUse | The INNO SLA Submerged ImplantSystem is indicated for use inpartially or fully edentulousmandibles and maxillae, in supportof single or multiple-unit restorationsincluding; cemented retained, screw-retained, or overdenture restorations,and terminal or intermediateabutment support for fixedbridgework. | The INNO SLA Submerged ImplantSystem is indicated for use inpartially or fully edentulousmandibles and maxillae, in supportof single or multiple-unit restorationsincluding; cemented retained, screw-retained, or overdenture restorations,and terminal or intermediateabutment support for fixedbridgework. | same |
| Appearance | Image: Two healing abutments | Image: A healing abutment | same and similar |
| Diameter | 6.5, 7.5, 8.0, 8.5, 9.5mm | 4.1, 4.5, 4.9, 5.5, 5.95, 6.5mm | large diameter |
| Post Height | 2, 5mm | 2, 3, 4, 5, 6, 7, 9mm | same |
| Gingival Height | 1, 2, 3, 4, 5, 7mm | 1, 2, 3, 4, 5, 7mm | same |
| ConnectionInterface | Hex, Non-hex | Hex, Non-hex | same |
| Surfacetreatment | N/A | N/A | same |
| Sterility | Non-sterile; intended for terminalsterilization via moistheat(autoclave) | Non-sterile; intended for terminalsterilization via moistheat(autoclave) | same |
| Angulation | 0° | 0° | same |
| Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI | same |
| Principle ofoperation | This component is intended toprotect the inner configuration of theimplant during the healing processand maintain, stabilize and form thesoft tissue during this phase. | This component is intended toprotect the inner configuration of theimplant during the healing processand maintain, stabilize and form thesoft tissue during this phase. | same |
● Healing Abutment
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The subject device has the same intended use, material, surface treatment, and design as the predicate device. This 510k is to add some more size options for diameter. The wider range is to meet each patient needs and larger diameter does not a concern in performance or safety.
| Subject Device | Predicate Device | ||
|---|---|---|---|
| 510(k) Number | K201323 | K132242 | |
| Device Name | Angulated Abutment forINNO SLA Submerged ImplantSystem | Angulated Abutment forINNO SLA Submerged ImplantSystem | Remark |
| Manufacturer | Cowellmedi Co., Ltd. | Cowellmedi Co., Ltd. | |
| Indications forUse | The INNO SLA Submerged ImplantSystem is indicated for use inpartially or fully edentulousmandibles and maxillae, in supportof single or multiple-unit restorationsincluding; cemented retained, screw-retained, or overdenture restorations,and terminal or intermediateabutment support for fixedbridgework. | The INNO SLA Submerged ImplantSystem is indicated for use inpartially or fully edentulousmandibles and maxillae, in supportof single or multiple-unit restorationsincluding; cemented retained, screw-retained, or overdenture restorations,and terminal or intermediateabutment support for fixedbridgework. | same |
| Appearance | Image: abutment | Image: abutment | same |
| Diameter | 4.5, 4.8, 5.5mm | 4.8mm | added small andlarge diameter |
| Post Height | 5, 8mm | 3.9, 4.9, 5.9, 6.9mm | added long height |
| Gingival Height | 1, 2, 3, 4mm | 1, 2, 3, 4mm | same |
| ConnectionInterface | Hex, Non-Hex | Hex, Non-Hex | same |
| Surfacetreatment | TiN Coating | TiN Coating | same |
| Sterility | Non-sterile; intended for terminalsterilization via moistheat(autoclave) | Non-sterile; intended for terminalsterilization via moistheat(autoclave) | same |
| Angulation | 15°, 25° | 15°, 25° | same |
| Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI | same |
| Principle ofoperation | This component is placed into dentalimplants to provide support forprosthetic restorations. It is forpermanent screw-retained abutment. | This component is placed into dentalimplants to provide support forprosthetic restorations. It is forpermanent screw-retained abutment. | same |
| Substantial Equivalence DiscussionThe subject device has the same intended use, material, surface treatment, and design as the predicate device. |
● Angulated Abutment
This 510k is to add some more size options for diameter and post height. The wider range is to meet each patient needs and the difference is minor. Also the additional size was verified by performance test.
● Temporary Abutment
| Subject Device | Predicate Device | ||
|---|---|---|---|
| 510(k) Number | K201323 | K132242 | |
| Device Name | Temporary Abutment forINNO SLA Submerged ImplantSystem | Temporary Abutment forINNO SLA Submerged ImplantSystem | Remark |
| Manufacturer | Cowellmedi Co., Ltd. | Cowellmedi Co., Ltd. | |
| Indications for Use | The INNO SLA Submerged ImplantSystem is indicated for use in | The INNO SLA Submerged ImplantSystem is indicated for use in | same |
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| partially or fully edentulousmandibles and maxillae, in supportof single or multiple-unit restorationsincluding; cemented retained, screw-retained, or overdenture restorations,and terminal or intermediateabutment support for fixedbridgework. | partially or fully edentulousmandibles and maxillae, in supportof single or multiple-unit restorationsincluding; cemented retained, screw-retained, or overdenture restorations,and terminal or intermediateabutment support for fixedbridgework. | ||
|---|---|---|---|
| Appearance | Image: abutment | Image: abutment | same |
| Diameter | 4.5mm | 4.8mm | added smalldiameter |
| Post Height | 10mm | 3.9, 4.9, 5.9, 6.9mm | added long height |
| Gingival Height | 1mm | 1, 2, 3, 4mm | same |
| ConnectionInterface | Hex, Non-Hex | Hex, Non-Hex | same |
| Surfacetreatment | N/A | N/A | same |
| Sterility | Non-sterile; intended for terminalsterilization via moistheat(autoclave) | Non-sterile; intended for terminalsterilization via moistheat(autoclave) | same |
| Angulation | 0° | 0° | same |
| Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI | same |
| Principle ofoperation | This component is a provisionalrestoration intended for use withroot-form endosseous dentalimplants to aid in prostheticrehabilitation or provisional crownthat aids in creating an estheticemergence through the gingivaduring the final prostheticproduction. | This component is a provisionalrestoration intended for use withroot-form endosseous dentalimplants to aid in prostheticrehabilitation or provisional crownthat aids in creating an estheticemergence through the gingivaduring the final prostheticproduction. | same |
| Substantial Equivalence Discussion | |||
| The subject device has the same intended use, material, surface treatment, and design as the predicate device. |
This 510k is to add some more size options for diameter and post height. The wider range is to meet each patient needs and the difference is minor.
● Sonator Abutment
| Subject Device | Predicate Device | ||
|---|---|---|---|
| 510(k) Number | K201323 | K072878 | |
| Device Name | Sonator Abutment forINNO SLA Submerged ImplantSystem | Locator Implant Anchor Abutmentfor Endosseous Dental Implant | Remark |
| Manufacturer | Cowellmedi Co., Ltd. | Zest Anchors, Inc. | |
| Indications forUse | The INNO SLA Submerged ImplantSystem is indicated for use inpartially or fully edentulousmandibles and maxillae, in supportof single or multiple-unit restorationsincluding; cemented retained, screw-retained, or overdenture restorations,and terminal or intermediateabutment support for fixedbridgework. | The LOCATOR Implant AnchorAbutment for Endosseous DentalImplants is appropriate for use withoverdentures or partial denturesretained in whole or in part byendosseous implants in the mandibleor maxilla. | similar |
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| Appearance | similar | ||
|---|---|---|---|
| Diameter | 3.87, 4.5mm | 3.25 to 6.5mm | same |
| Gingival Height | 1, 1.5, 2, 3, 4, 5, 6mm | 1, 2, 3, 4, 5, 6 mm | same |
| ConnectionInterface | Hex, Non-hex | Conical, External Hex, Internal Hex,Internal Multi Lobe | similar |
| Surfacetreatment | TiN Coating | TiN Coating | same |
| Sterility | Non-sterile; intended for terminalsterilization via moistheat(autoclave) | Non-sterile; intended for terminalsterilization via moistheat(autoclave) | same |
| Angulation | 0, 15° | 0°, 10°, 20° | same |
| Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI | same |
| Principle ofoperation | This component is used for implant-retained muscosa-supportedrestorations, such as dentures. Itsupports implant retained mucosssupported over dentures. | This component is used for implant-retained muscosa-supportedrestorations, such as dentures. Itsupports implant retained mucosssupported over dentures. | similar |
| Substantial Equivalence Discussion | |||
| The subject device has the same intended use, material, surface treatment, and design as the predicate device. Thewording of the indications for use is different but the overall claims are the same between the devices. The wordingof the subject device is more specific. |
The size range of the predicate device encompasses that of the subject device, so it does not raise an issue in performance or safety.
8. Non-Clinical Testing
- Surface Modification: The TiN coating for the subject abutments has the same ● specifications and processes as the predicate device cleared under K132242. The surface modification information for the TiN coating as recommended in the FDA Guidance, "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments" was provided in K132242 and leveraged for the subject devices.
- Cytotoxicity Testing provided on representative abutments with TiN coating as . cleared under K132242 with the same raw materials and manufacturing processes as the subject devices. Cytotoxicity testing was performed according to ANSI/AAMI/ISO 10993-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity, and ISO 10993-12 Biological evaluation of medical devices -Part 12: Sample preparation and reference materials.
- Mechanical performance testing of the subject device was performed according to ISO 14801. The worst-case scenario was chosen based on the FDA Guidance, "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments." The fatigue limit data demonstrated that constructs of the subject device abutments in combination with the stated compatible implants and used according to the proposed labeling, have sufficient strength for their intended use and are substantially equivalent to predicate devices with regard to mechanical performance.
- End-user sterility validation was conducted according to ISO 17665-1 and ISO 17665-2 for the prior clearance K132242 and leveraged for the subject devices.
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9. Conclusion
The subject devices and the predicate device have the same intended use and have the same technological characteristics.
Overall, the INNO SLA Submerged Implant System has the following similarities to the predicate device:
-
- have the same intended use,
-
- use the same operating principle,
-
- incorporate similar design,
-
- incorporate the same material and the sterilization method
Based on the similarities, we conclude that the INNO Sub Implant System is substantially equivalent to the predicate devices.
§ 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.)