FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Protective Cap
K Number: K232528
·
Decision Apr 30, 2024
Classifications
1
FEI Numbers
382
Registration Numbers
382
Same Product Code
708
Applicant Total
17
Review Days
253
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Basic Information
- Device Name
- Protective Cap
- K Number
- K232528
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3630
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Neobiotech Co., Ltd.
- Date Received
- August 21, 2023
- Decision Date
- April 30, 2024
- 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 Neobiotech Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K232049 | IS-III active Short Implant | Mar 28, 2024 | Substantially Equivalent |
| K210903 | IS Multi Unit Abutment System | Jul 23, 2021 | Substantially Equivalent |
| K190849 | IS-III active System_S-narrow Type | Aug 14, 2019 | Substantially Equivalent |
| K181137 | IT-III active System | Nov 16, 2018 | Substantially Equivalent |
| K181138 | IS-III active System | Oct 3, 2018 | Substantially Equivalent |
| K181178 | S-mini active Fixture | Jul 24, 2018 | Substantially Equivalent |
| K173938 | IS-III HActive Fixture | May 24, 2018 | Substantially Equivalent |
| K160991 | Neo GBR System | Jan 10, 2017 | Substantially Equivalent |
| K120503 | CMI IMPLANT IS II ACTIVE | Jun 18, 2012 | Substantially Equivalent |
| K113554 | CMI IMPLANT IS SYSTEM | Apr 5, 2012 | Substantially Equivalent |