FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
INNO SLA Mini Plus® Implant System
K Number: K241127
·
Decision Dec 27, 2024
Classifications
1
FEI Numbers
324
Registration Numbers
324
Same Product Code
1545
Applicant Total
14
Review Days
248
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Basic Information
- Device Name
- INNO SLA Mini Plus® Implant System
- K Number
- K241127
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cowellmedi Co., Ltd.
- Date Received
- April 23, 2024
- Decision Date
- December 27, 2024
- Product Code
- DZE
- 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 |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | FDA class 2 | Dental |
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Other Clearances by Cowellmedi Co., Ltd.
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|---|---|---|---|
| K242287 | SFIT Abutment | Sep 16, 2025 | Substantially Equivalent |
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| 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 |
| K201323 | INNO SLA Submerged Implant System | Jan 25, 2022 | 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 |