Registered with FDA
CreoDent Prosthetics LTD
New York, NY, United States. Lists 5 dental device types with FDA across 1 registered establishment, and holds 9 510(k) clearances as applicant.
- Device types listed
- 5
- Brands and models
- 5
- 510(k) clearances
- 92013–2022
- Markets registered in
- 1United States
- Establishments
- 1United States
510(k) clearances per year, 2007–2026
Devices listed with FDA
What CreoDent Prosthetics LTD currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Preformed BarEHO · Class 1 | — | Lister | Bars | 2023 |
| Preformed ClaspEHP · Class 1 | — | Lister | Clasp | 2023 |
| Wire ClaspEJW · Class 1 | — | Lister | Clasp | 2023 |
| Denture Preformed (Partially Prefabricated Denture)EKO · Class 2 | Denture resins & teeth | Lister | Denture | 2023 |
| Preformed CrownELZ · Class 1 | — | Lister | Crown | 2023 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names CreoDent Prosthetics LTD as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 2 Dec 2022 | K220390 | CreoDent Solidex Customized Abutment and Screw | NHA Endosseous Dental Implant Abutment |
| 13 Oct 2022 | K211427 | CREOKORREKT Aligners | NXC Sequential Aligner |
| 2 Apr 2021 | K202909 | CreoDent Solidex Customized Abutment | NHA Endosseous Dental Implant Abutment |
| 16 Dec 2020 | K202095 | CreoDent Solidex Customized Abutment and Screw | NHA Endosseous Dental Implant Abutment |
| 18 Jul 2017 | K170100 | CreoDent Solidex Customized Abutment and Screw | NHA Endosseous Dental Implant Abutment |
| 8 May 2017 | K162734 | CreoDent Solidex Customized Abutment | NHA Endosseous Dental Implant Abutment |
| 29 Sep 2016 | K160436 | CreoDent Solidex Custom Abutment | NHA Endosseous Dental Implant Abutment |
| 4 Jun 2015 | K150012 | CreoDent Solidex Customized Abutment | NHA Endosseous Dental Implant Abutment |
| 17 Sep 2013 | K113738 | CREODENT SOLIDEX CUSTOM ABUTMENT | NHA Endosseous Dental Implant Abutment |
Some of these clearances are listed with FDA today by another company: Creodent Hudson Valley (9).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| CREODENT PROSTHETICS LTDFDA reg. 3009711592 | New York, NY, United States | Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10041444). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.