The following data is part of a premarket notification filed by Degussa Dental, Inc. with the FDA for Biosil F.
Device ID | K861820 |
510k Number | K861820 |
Device Name: | BIOSIL F |
Classification | Alloy, Metal, Base |
Applicant | DEGUSSA DENTAL, INC. 21-25 44TH AVE. Long Island, NY 11101 |
Contact | Manohar Malhotra |
Correspondent | Manohar Malhotra DEGUSSA DENTAL, INC. 21-25 44TH AVE. Long Island, NY 11101 |
Product Code | EJH |
CFR Regulation Number | 872.3710 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-05-12 |
Decision Date | 1986-06-13 |