FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
IS-III active Short Implant
K Number: K232049
·
Decision Mar 28, 2024
Classifications
1
FEI Numbers
324
Registration Numbers
324
Same Product Code
1545
Applicant Total
17
Review Days
262
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Basic Information
- Device Name
- IS-III active Short Implant
- K Number
- K232049
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Neobiotech Co., Ltd.
- Date Received
- July 10, 2023
- Decision Date
- March 28, 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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|---|---|---|---|
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| K160991 | Neo GBR System | Jan 10, 2017 | Substantially Equivalent |
| K120503 | CMI IMPLANT IS II ACTIVE | Jun 18, 2012 | Substantially Equivalent |
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