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 |