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 |