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 |