The following data is part of a premarket notification filed by Preat Corporation with the FDA for Preat Abutments.
Device ID | K183518 |
510k Number | K183518 |
Device Name: | Preat Abutments |
Classification | Abutment, Implant, Dental, Endosseous |
Applicant | Preat Corporation 100 S. 4th Street Grover Beach, CA 93433 |
Contact | Chris Bormes |
Correspondent | Kevin A. Thomas PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, CA 92130 |
Product Code | NHA |
CFR Regulation Number | 872.3630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-12-18 |
Decision Date | 2019-03-18 |