The following data is part of a premarket notification filed by Degussa Dental, Inc. with the FDA for Pors-on Hf-solder(porcelain Dental Alloys).
Device ID | K850193 |
510k Number | K850193 |
Device Name: | PORS-ON HF-SOLDER(PORCELAIN DENTAL ALLOYS) |
Classification | Alloy, Other Noble Metal |
Applicant | DEGUSSA DENTAL, INC. 21-25 44TH AVE. Long Island, NY 11101 |
Contact | Lal Malhotra |
Correspondent | Lal Malhotra DEGUSSA DENTAL, INC. 21-25 44TH AVE. Long Island, NY 11101 |
Product Code | EJS |
CFR Regulation Number | 872.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-01-18 |
Decision Date | 1985-02-08 |