The following data is part of a premarket notification filed by Creodent Prosthetics, Ltd. with the FDA for Creodent Solidex Customized Abutment.
| Device ID | K202909 |
| 510k Number | K202909 |
| Device Name: | CreoDent Solidex Customized Abutment |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | CreoDent Prosthetics, Ltd. 29 West 30th Street, 11th Floor New York, NY 10001 |
| Contact | Calvin Shim |
| Correspondent | Chris Brown Aclivi, LLC 6455 Farley Road Pinckney, MI 48169 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-29 |
| Decision Date | 2021-04-02 |