The following data is part of a premarket notification filed by Creodent Prosthetics, Ltd. with the FDA for Creodent Solidex Customized Abutment And Screw.
| Device ID | K220390 |
| 510k Number | K220390 |
| Device Name: | CreoDent Solidex Customized Abutment And Screw |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | CreoDent Prosthetics, Ltd. 29 West 30th Street, 11th Floor New York, NY 10001 |
| Contact | Calvin Shim |
| Correspondent | Calvin Shim CreoDent Prosthetics, Ltd. 29 West 30th Street, 11th Floor New York, NY 10001 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-11 |
| Decision Date | 2022-12-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D124NODGSCA0 | K220390 | 000 |
| D124NODGAS0 | K220390 | 000 |
| D124NODGBL0 | K220390 | 000 |
| D124NODGC150 | K220390 | 000 |
| D124NODGC250 | K220390 | 000 |
| D124NODGC350 | K220390 | 000 |
| D124NODGC450 | K220390 | 000 |
| D124NODGS0 | K220390 | 000 |
| D124IA35S100 | K220390 | 000 |
| D124IA35S50 | K220390 | 000 |
| D124NODGAS100 | K220390 | 000 |
| D124NODGAS50 | K220390 | 000 |
| D124NODGS100 | K220390 | 000 |
| D124NODGS5 | K220390 | 000 |
| D124IA35SCA0 | K220390 | 000 |
| D124NODG0 | K220390 | 000 |