The following data is part of a premarket notification filed by Parkell with the FDA for Metafil.
| Device ID | K923867 |
| 510k Number | K923867 |
| Device Name: | METAFIL |
| Classification | Material, Tooth Shade, Resin |
| Applicant | PARKELL 155 SCHMITT BLVD. P.O. BOX 376 Farmingdale, NY 11735 |
| Contact | Nelson J Gendusa |
| Correspondent | Nelson J Gendusa PARKELL 155 SCHMITT BLVD. P.O. BOX 376 Farmingdale, NY 11735 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-03 |
| Decision Date | 1992-10-06 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() METAFIL 75624997 2787787 Dead/Cancelled |
Metallurgica Gesellschaft fur Huttenwerkstechnik mbH & Co. KG 1998-08-10 |
![]() METAFIL 73106100 1071496 Dead/Expired |
MBASSOCIATES 1976-11-10 |