The following data is part of a premarket notification filed by Facial Alveodental Implant Rehabilitation, Inc. with the FDA for Flexiroot.
| Device ID | K852305 |
| 510k Number | K852305 |
| Device Name: | FLEXIROOT |
| Classification | Implant, Endosseous, Root-form |
| Applicant | FACIAL ALVEODENTAL IMPLANT REHABILITATION, INC. 1617 BROADWAY, SUITE 10 Vallejo, CA 96590 |
| Contact | Peter G Mozsary |
| Correspondent | Peter G Mozsary FACIAL ALVEODENTAL IMPLANT REHABILITATION, INC. 1617 BROADWAY, SUITE 10 Vallejo, CA 96590 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-29 |
| Decision Date | 1985-10-16 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() FLEXIROOT 73588623 1493748 Dead/Cancelled |
FACIAL ALVEODENTAL IMPLANT REHABILITATION, INC. 1986-03-17 |