FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
INNO SLA Submerged Implant System
K Number: K201323
·
Decision Jan 25, 2022
Classifications
1
FEI Numbers
382
Registration Numbers
382
Same Product Code
708
Applicant Total
14
Review Days
617
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Basic Information
- Device Name
- INNO SLA Submerged Implant System
- K Number
- K201323
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3630
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cowellmedi Co., Ltd.
- Date Received
- May 18, 2020
- Decision Date
- January 25, 2022
- Product Code
- NHA
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NHA | Abutment, Implant, Dental, Endosseous | FDA class 2 | Dental |
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Other Clearances by Cowellmedi Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K242287 | SFIT Abutment | Sep 16, 2025 | Substantially Equivalent |
| K241127 | INNO SLA Mini Plus® Implant System | Dec 27, 2024 | Substantially Equivalent |
| K231411 | INNO SLA Submerged Hybrid Ti-Base System | Dec 20, 2023 | Substantially Equivalent |
| K232546 | Meta G UCLA Abutment | Nov 21, 2023 | Substantially Equivalent |
| K231395 | INNO SLA Submerged Narrow Implant System | Oct 18, 2023 | Substantially Equivalent |
| K211554 | InnoGenic Non-resorbable Membrane | Feb 24, 2023 | Substantially Equivalent |
| K132242 | INNO SLA SUBMERGED IMPLANT SYSTEM | Dec 6, 2013 | Substantially Equivalent |
| K100850 | COWELL IMPLANT SYSTEM | Dec 20, 2010 | Substantially Equivalent |
| K090054 | ATLAS IMPLANT SYSTEM - WIDE PLUS | Jul 29, 2009 | Substantially Equivalent |
| K090049 | ATLAS IMPLANT SYSTEM- MINI PLUS | Apr 20, 2009 | Substantially Equivalent |