Creodent Prosthetics, Ltd.
Creodent Prosthetics, Ltd. has 0 FDA recalls, 4 inspections, 9 510(k) clearances and 0 compliance actions on record.
- Latest inspection
- Jan 14, 2026 · NAI
- Latest 510(k)
- Dec 2, 2022
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Oct 23, 2026 | Not stated | Current |
| 510(k) clearances | 9 | Oct 4, 2026 | Not stated | Current |
| Inspections | 4 | Oct 23, 2026 | Not stated | Current |
| Compliance actions | 0 | Oct 23, 2026 | Not stated | Current |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jan 14, 2026 | New York, NY | Devices | No Action Indicated (NAI) | 3009711592 |
| Jun 14, 2023 | New York, NY | Devices | Voluntary Action Indicated (VAI) | 3009711592 |
| Nov 4, 2021 | New York, NY | Devices | No Action Indicated (NAI) | 3009711592 |
| Feb 2, 2018 | New York, NY | Devices | No Action Indicated (NAI) | 3009711592 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K220390 | CreoDent Solidex Customized Abutment and Screw | Dec 2, 2022 |
| K211427 | CREOKORREKT Aligners | Oct 13, 2022 |
| K202909 | CreoDent Solidex Customized Abutment | Apr 2, 2021 |
| K202095 | CreoDent Solidex Customized Abutment and Screw | Dec 16, 2020 |
| K170100 | CreoDent Solidex Customized Abutment and Screw | Jul 18, 2017 |
| K162734 | CreoDent Solidex Customized Abutment | May 8, 2017 |
| K160436 | CreoDent Solidex Custom Abutment | Sep 29, 2016 |
| K150012 | CreoDent Solidex Customized Abutment | Jun 4, 2015 |
| K113738 | CREODENT SOLIDEX CUSTOM ABUTMENT | Sep 17, 2013 |