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 |