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 |