The following data is part of a premarket notification filed by Degussa Dental, Inc. with the FDA for Duceram-metal-ceramic Dental Porcelain System.
Device ID | K871808 |
510k Number | K871808 |
Device Name: | DUCERAM-METAL-CERAMIC DENTAL PORCELAIN SYSTEM |
Classification | Teeth, Porcelain |
Applicant | DEGUSSA DENTAL, INC. 21-25 44TH AVE. Long Island, NY 11101 |
Contact | Dr. J Rothaut |
Correspondent | Dr. J Rothaut DEGUSSA DENTAL, INC. 21-25 44TH AVE. Long Island, NY 11101 |
Product Code | ELL |
CFR Regulation Number | 872.3920 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-05-08 |
Decision Date | 1987-06-05 |