The following data is part of a premarket notification filed by Degussa Dental, Inc. with the FDA for Biosil H.
| Device ID | K861787 |
| 510k Number | K861787 |
| Device Name: | BIOSIL H |
| Classification | Alloy, Metal, Base |
| 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 | EJH |
| CFR Regulation Number | 872.3710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-08 |
| Decision Date | 1986-05-21 |