The following data is part of a premarket notification filed by Preat Corporation with the FDA for Preat Abutments.
Device ID | K220823 |
510k Number | K220823 |
Device Name: | Preat Abutments |
Classification | Abutment, Implant, Dental, Endosseous |
Applicant | Preat Corporation 2625 Skyway Dr, Suite B Santa Maria, CA 93455 |
Contact | Chris Bormes |
Correspondent | Chris Brown Aclivi, LLC 3250 Brackley Drive Ann Arbor, MI 48105 |
Product Code | NHA |
CFR Regulation Number | 872.3630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2022-03-21 |
Decision Date | 2022-10-26 |