The following data is part of a premarket notification filed by Prodent Intl., Inc. with the FDA for Fixtector.
| Device ID | K864572 |
| 510k Number | K864572 |
| Device Name: | FIXTECTOR |
| Classification | Paper, Articulation |
| Applicant | PRODENT INTL., INC. 111 NORTH ALFRED ST. P.O. BOX 299 Alexandria, VA 22313 |
| Contact | Stephen A Bent |
| Correspondent | Stephen A Bent PRODENT INTL., INC. 111 NORTH ALFRED ST. P.O. BOX 299 Alexandria, VA 22313 |
| Product Code | EFH |
| CFR Regulation Number | 872.6140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-20 |
| Decision Date | 1987-02-12 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() FIXTECTOR 73615918 1453859 Dead/Cancelled |
PRODENT GESELLSCHAFT FUR ZAHNARZTLICHE BEDARFSARTIKEL M.B.H. 1986-08-21 |