The following data is part of a premarket notification filed by Advantage Dental Products, Inc. with the FDA for Hemaseal & Cide.
| Device ID | K990779 |
| 510k Number | K990779 |
| Device Name: | HEMASEAL & CIDE |
| Classification | Varnish, Cavity |
| Applicant | ADVANTAGE DENTAL PRODUCTS, INC. 4498 KLAIS DR. Clarkston, MI 48348 |
| Contact | Ingrid K Pelerin |
| Correspondent | Ingrid K Pelerin ADVANTAGE DENTAL PRODUCTS, INC. 4498 KLAIS DR. Clarkston, MI 48348 |
| Product Code | LBH |
| CFR Regulation Number | 872.3260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-09 |
| Decision Date | 1999-11-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10859787002045 | K990779 | 000 |
| 10859787002007 | K990779 | 000 |