The following data is part of a premarket notification filed by Den-mat Corp. with the FDA for Den-mat Poretch (porcelain Etchant).
Device ID | K875351 |
510k Number | K875351 |
Device Name: | DEN-MAT PORETCH (PORCELAIN ETCHANT) |
Classification | Teeth, Porcelain |
Applicant | DEN-MAT CORP. P.O. BOX 1729 Santa Maria, CA 93456 |
Contact | Robert Ibsen |
Correspondent | Robert Ibsen DEN-MAT CORP. P.O. BOX 1729 Santa Maria, CA 93456 |
Product Code | ELL |
CFR Regulation Number | 872.3920 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-12-31 |
Decision Date | 1988-03-18 |