The following data is part of a premarket notification filed by Degussa Ag with the FDA for Duceratin/duceram Lfc Dental Porcelain.
Device ID | K921479 |
510k Number | K921479 |
Device Name: | DUCERATIN/DUCERAM LFC DENTAL PORCELAIN |
Classification | Powder, Porcelain |
Applicant | DEGUSSA AG 3950 SOUTH CLINTON AVE. South Plainfield, NJ 07080 |
Contact | Holger Meinicke |
Correspondent | Holger Meinicke DEGUSSA AG 3950 SOUTH CLINTON AVE. South Plainfield, NJ 07080 |
Product Code | EIH |
CFR Regulation Number | 872.6660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-03-30 |
Decision Date | 1992-06-22 |