Creodent Prosthetics, Ltd.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Creodent Prosthetics, Ltd.” (first 2013, latest 2022), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 220 days. Since 2017 the median was 204 days, against 159 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2013 | 1 | 637 |
| 2014 | 0 | — |
| 2015 | 1 | 150 |
| 2016 | 1 | 225 |
| 2017 | 2 | 204 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 140 |
| 2021 | 1 | 185 |
| 2022 | 2 | 409 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Creodent Prosthetics, Ltd. took a median 204 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 159 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NHA | Abutment, Implant, Dental, Endosseous | 8 | 8 |
| NXC | Aligner, Sequential | 1 | 1 |
Review panels
- Dental (9)
Most recent Creodent Prosthetics, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K220390 | CreoDent Solidex Customized Abutment and Screw | NHA | 2022-12-02 | 294 |
| K211427 | CREOKORREKT Aligners | NXC | 2022-10-13 | 524 |
| K202909 | CreoDent Solidex Customized Abutment | NHA | 2021-04-02 | 185 |
| K202095 | CreoDent Solidex Customized Abutment and Screw | NHA | 2020-12-16 | 140 |
| K170100 | CreoDent Solidex Customized Abutment and Screw | NHA | 2017-07-18 | 188 |
| K162734 | CreoDent Solidex Customized Abutment | NHA | 2017-05-08 | 220 |
| K160436 | CreoDent Solidex Custom Abutment | NHA | 2016-09-29 | 225 |
| K150012 | CreoDent Solidex Customized Abutment | NHA | 2015-06-04 | 150 |
| K113738 | CREODENT SOLIDEX CUSTOM ABUTMENT | NHA | 2013-09-17 | 637 |
Recalls
openFDA lists no recalls under a recalling firm named Creodent Prosthetics, Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- CreoDent Hudson Valley (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Creodent Prosthetics, Ltd.?
FDA lists 9 510(k) clearances under the applicant name “Creodent Prosthetics, Ltd.” (first 2013, latest 2022), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Creodent Prosthetics, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Creodent Prosthetics, Ltd. is 220 days. Since 2017: 204 days, versus 159 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Creodent Prosthetics, Ltd.?
The most frequent FDA product codes under this applicant name are NHA (Abutment, Implant, Dental, Endosseous, 8); NXC (Aligner, Sequential, 1).
Next steps
- See all 9 Creodent Prosthetics, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code NHA, Creodent Prosthetics, Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.