The following data is part of a premarket notification filed by Den-mat Corp. with the FDA for Den-mat Cerinate Porcelain.
Device ID | K895731 |
510k Number | K895731 |
Device Name: | DEN-MAT CERINATE PORCELAIN |
Classification | Powder, Porcelain |
Applicant | DEN-MAT CORP. P.O. BOX 1729 Santa Maria, CA 93456 |
Contact | W. R Glace |
Correspondent | W. R Glace DEN-MAT CORP. P.O. BOX 1729 Santa Maria, CA 93456 |
Product Code | EIH |
CFR Regulation Number | 872.6660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-09-26 |
Decision Date | 1990-08-03 |