INNO SLA Submerged Implant System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K201323 FDA 510(k)
- FDA Product Code
- NHA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3630 FDA 510(k)
- Regulation Number
- 872.3630 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The INNO SLA Submerged Implant System is a dental implant device designed for osseointegration in the jawbone. It features a submerged healing abutment to promote bone growth around the implant, ensuring stable integration before exposure.
This system is supplied sterile and intended for single-use in dental clinical settings. It is classified under the product code NHA and has received FDA 510(k) clearance and MDD authorization. The device is manufactured by Cowellmedi Co., Ltd., based in Busan, South Korea.
Frequently asked questions
What is the primary purpose of the submerged healing abutment included in the INNO SLA Submerged Implant System?
The submerged healing abutment in the INNO SLA Submerged Implant System is designed to promote osseointegration—meaning it encourages bone growth around the implant during the healing phase. By keeping the abutment submerged beneath the gum tissue, the system ensures stable integration of the implant into the jawbone before it is exposed for final restoration.
Is the INNO SLA Submerged Implant System intended for reuse, or is it meant to be used only once?
The INNO SLA Submerged Implant System is explicitly intended for single-use in dental clinical settings. This ensures patient safety and sterility, as the device is supplied sterile and not designed for repeated use.
How is the INNO SLA Submerged Implant System classified under regulatory frameworks, and what does that mean for its use?
The system is classified under product code NHA (Dental Implants) and has received FDA 510(k) clearance and MDD authorization, confirming it meets regulatory standards for dental implants in the U.S. and European markets. This classification ensures it adheres to safety and performance requirements for osseointegrated dental implants.
What details should I know about storage and handling of the INNO SLA Submerged Implant System?
While the exact storage instructions aren’t detailed in the provided data, the system is sterile upon supply, so it should be stored in a clean, dry environment as per standard sterile medical device protocols. Avoid exposure to moisture, extreme temperatures, or contamination to maintain its integrity before use.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Inno+ | We energise farming - Inno-plus
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K201323 | Class II | Active |
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Manufacturer
- Manufacturer
- Cowellmedi Co., Ltd
- FDA Applicant
- Cowellmedi Co., Ltd.
Sources (2)
- FDA 510(k) K201323 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026