The following data is part of a premarket notification filed by Degussa Dental, Inc. with the FDA for Pontallor 4 Dental Alloy.
Device ID | K870024 |
510k Number | K870024 |
Device Name: | PONTALLOR 4 DENTAL ALLOY |
Classification | Alloy, Gold-based Noble Metal |
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 | EJT |
CFR Regulation Number | 872.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-01-05 |
Decision Date | 1987-03-11 |