(617 days)
No
The document describes a dental implant system and its components, focusing on mechanical performance testing and equivalence to predicate devices. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is an implant system used for dental restorations, which is a structural and supportive function, not a therapeutic one as defined by actively treating a disease or condition.
No
The provided text describes a dental implant system and its components, indicating its use for restorative purposes (e.g., supporting single or multiple-unit restorations, fixed bridgework). It does not mention any function related to diagnosing medical conditions or diseases.
No
The device description explicitly lists physical components (Healing Abutment, Angulated Abutment, etc.) and mentions mechanical performance testing, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as being used in the body (mandibles and maxillae) to support dental restorations. IVDs are used outside the body to examine specimens (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The components listed (abutments, screws) are all parts of a dental implant system designed for surgical implantation and support of dental prosthetics.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, diagnostic purposes, or any of the typical characteristics of an IVD.
This device is clearly a medical device intended for surgical implantation and dental restoration, not an in vitro diagnostic device.
N/A
Intended Use / Indications 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, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device 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.
Components:
- Healing Abutment Type A (Ø7.5 x 10.7mm, Ø 8.5 x 10.7 mm, Ø 9.5 x 10.7mm)
- Healing Abutment Type B (Ø 6.5 x 5.9, 6.9, 7.9, 8.9, 9.9, 11.9 mm; Ø 7.5 x 5.9, 6.9, 7.9, 8.9, 9.9, 11.9 mm; Ø 8.0 x 5.9, 6.9, 7.9, 8.9, 9.9, 11.9 mm; Ø 8.5 x 5.9, 6.9, 7.9, 8.9, 9.9, 11.9 mm; Ø 9.5 x 5.9, 6.9, 7.9, 8.9, 9.9, 11.9 mm)
- Angulated Abutment (Ø 4.5 x 11.9, 12.9, 13.9, 14.9mm; Ø 4.8 x 9.4, 10.4, 11.4mm; Ø 5.5 x 11.9, 12.9, 13.9, 14.9mm)
- Temporary Abutment (Ø 4.5 x 13.65,13.9mm)
- Sonator S Abutment (Ø 3.87 x 8.3, 9.3, 10.3, 11.3, 12.3, 13.3mm)
- Sonator A Abutment (Ø 3.87 x 7.15, 8.7mm)
- Screw (Ø 2.15 x 6.5, 7.5, 8.5mm; Ø 2.2 x 7.8, 8.8, 9.8mm; Ø 2.28 x 5mm; Ø 2.45 x 8.5mm)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
partially or fully edentulous mandibles and maxillae
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)
- 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: 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: conducted according to ISO 17665-1 and ISO 17665-2 for the prior clearance K132242 and leveraged for the subject devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
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.
1
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
2
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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3
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)
4
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 Abutment | |||
| Type A | ||||
| Ø7.5 x 10.7mm | ||||
| Ø 8.5 x 10.7 mm | ||||
| Ø 9.5 x 10.7mm | ||||
| 2 | Type B | |||
| Ø 6.5 x 5.9, 6.9, 7.9, 8.9, 9.9, 11.9 mm | ||||
| Ø 7.5 x 5.9, 6.9, 7.9, 8.9, 9.9, 11.9 mm | ||||
| Ø 8.0 x 5.9, 6.9, 7.9, 8.9, 9.9, 11.9 mm | ||||
| Ø 8.5 x 5.9, 6.9, 7.9, 8.9, 9.9, 11.9 mm | ||||
| Ø 9.5 x 5.9, 6.9, 7.9, 8.9, 9.9, 11.9 mm | ||||
| 3 | Angulated Abutment | |||
| Ø 4.5 x 11.9, 12.9, 13.9, 14.9mm | ||||
| Ø 4.8 x 9.4, 10.4, 11.4mm | ||||
| Ø 5.5 x 11.9, 12.9, 13.9, 14.9mm | ||||
| 5 | Temporary Abutment | |||
| Ø 4.5 x 13.65,13.9mm | ||||
| 6 | Sonator S Abutment | |||
| Ø 3.87 x 8.3, 9.3, 10.3, 11.3, 12.3, 13.3mm | ||||
| 7 | Sonator A Abutment | |||
| Ø 3.87 x 7.15, 8.7mm | ||||
| 8 | Screw | |||
| Ø 2.15 x 6.5, 7.5, 8.5mm | ||||
| Ø 2.2 x 7.8, 8.8, 9.8mm | ||||
| Ø 2.28 x 5mm | ||||
| Ø 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.
5
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 for | ||
| INNO SLA Submerged Implant | |||
| System | Healing Abutment for | ||
| INNO SLA Submerged Implant | |||
| System | Remark | ||
| Manufacturer | Cowellmedi Co., Ltd. | Cowellmedi Co., Ltd. | |
| Indications 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. | The INNO SLA Submerged Implant | ||
| System is indicated for use in | |||
| partially or fully edentulous | |||
| mandibles and maxillae, in supportof single or multiple-unit restorations | |||
| including; cemented retained, screw- | |||
| retained, or overdenture restorations, | |||
| and terminal or intermediate | |||
| abutment support for fixed | |||
| bridgework. | 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 |
| Connection | |||
| Interface | Hex, Non-hex | Hex, Non-hex | same |
| Surface | |||
| treatment | N/A | N/A | same |
| Sterility | Non-sterile; intended for terminal | ||
| sterilization via moist | |||
| heat(autoclave) | Non-sterile; intended for terminal | ||
| sterilization via moist | |||
| heat(autoclave) | same | ||
| Angulation | 0° | 0° | same |
| Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI | same |
| Principle of | |||
| operation | This component is intended to | ||
| protect the inner configuration of the | |||
| implant during the healing process | |||
| and maintain, stabilize and form the | |||
| soft tissue during this phase. | This component is intended to | ||
| protect the inner configuration of the | |||
| implant during the healing process | |||
| and maintain, stabilize and form the | |||
| soft tissue during this phase. | same |
● Healing Abutment
6
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 for | ||
| INNO SLA Submerged Implant | |||
| System | Angulated Abutment for | ||
| INNO SLA Submerged Implant | |||
| System | Remark | ||
| Manufacturer | Cowellmedi Co., Ltd. | Cowellmedi Co., Ltd. | |
| Indications 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. | 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. | same | ||
| Appearance | Image: abutment | Image: abutment | same |
| Diameter | 4.5, 4.8, 5.5mm | 4.8mm | added small and |
| large 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 |
| Connection | |||
| Interface | Hex, Non-Hex | Hex, Non-Hex | same |
| Surface | |||
| treatment | TiN Coating | TiN Coating | same |
| Sterility | Non-sterile; intended for terminal | ||
| sterilization via moist | |||
| heat(autoclave) | Non-sterile; intended for terminal | ||
| sterilization via moist | |||
| heat(autoclave) | same | ||
| Angulation | 15°, 25° | 15°, 25° | same |
| Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI | same |
| Principle of | |||
| operation | This component is placed into dental | ||
| implants to provide support for | |||
| prosthetic restorations. It is for | |||
| permanent screw-retained abutment. | This component is placed into dental | ||
| implants to provide support for | |||
| prosthetic restorations. It is for | |||
| permanent screw-retained abutment. | same | ||
| Substantial Equivalence Discussion | |||
| The 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 for | ||
| INNO SLA Submerged Implant | |||
| System | Temporary Abutment for | ||
| INNO SLA Submerged Implant | |||
| System | Remark | ||
| Manufacturer | Cowellmedi Co., Ltd. | Cowellmedi Co., Ltd. | |
| Indications for Use | The INNO SLA Submerged Implant | ||
| System is indicated for use in | The INNO SLA Submerged Implant | ||
| System is indicated for use in | same |
7
| | 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. | 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. | |
|----------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Appearance | Image: abutment | Image: abutment | same |
| Diameter | 4.5mm | 4.8mm | added small
diameter |
| Post Height | 10mm | 3.9, 4.9, 5.9, 6.9mm | added long height |
| Gingival Height | 1mm | 1, 2, 3, 4mm | same |
| Connection
Interface | Hex, Non-Hex | Hex, Non-Hex | same |
| Surface
treatment | N/A | N/A | same |
| Sterility | Non-sterile; intended for terminal
sterilization via moist
heat(autoclave) | Non-sterile; intended for terminal
sterilization via moist
heat(autoclave) | same |
| Angulation | 0° | 0° | same |
| Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI | same |
| Principle of
operation | This component is a provisional
restoration intended for use with
root-form endosseous dental
implants to aid in prosthetic
rehabilitation or provisional crown
that aids in creating an esthetic
emergence through the gingiva
during the final prosthetic
production. | This component is a provisional
restoration intended for use with
root-form endosseous dental
implants to aid in prosthetic
rehabilitation or provisional crown
that aids in creating an esthetic
emergence through the gingiva
during the final prosthetic
production. | 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 for | ||
| INNO SLA Submerged Implant | |||
| System | Locator Implant Anchor Abutment | ||
| for Endosseous Dental Implant | Remark | ||
| Manufacturer | Cowellmedi Co., Ltd. | Zest Anchors, Inc. | |
| Indications 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. | The LOCATOR Implant Anchor | ||
| Abutment for Endosseous Dental | |||
| Implants is appropriate for use with | |||
| overdentures or partial dentures | |||
| retained in whole or in part by | |||
| endosseous implants in the mandible | |||
| or maxilla. | similar |
8
| 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 |
| Connection | |||
| Interface | Hex, Non-hex | Conical, External Hex, Internal Hex, | |
| Internal Multi Lobe | similar | ||
| Surface | |||
| treatment | TiN Coating | TiN Coating | same |
| Sterility | Non-sterile; intended for terminal | ||
| sterilization via moist | |||
| heat(autoclave) | Non-sterile; intended for terminal | ||
| sterilization via moist | |||
| heat(autoclave) | same | ||
| Angulation | 0, 15° | 0°, 10°, 20° | same |
| Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI | same |
| Principle of | |||
| operation | This component is used for implant- | ||
| retained muscosa-supported | |||
| restorations, such as dentures. It | |||
| supports implant retained mucoss | |||
| supported over dentures. | This component is used for implant- | ||
| retained muscosa-supported | |||
| restorations, such as dentures. It | |||
| supports implant retained mucoss | |||
| supported over dentures. | similar | ||
| Substantial Equivalence Discussion | |||
| The subject device has the same intended use, material, surface treatment, and design as the predicate device. The | |||
| wording of the indications for use is different but the overall claims are the same between the devices. The wording | |||
| of 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.
9
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,
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- use the same operating principle,
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- incorporate similar design,
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- 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.