The following data is part of a premarket notification filed by Adpharma, Inc. with the FDA for Adpharma Occlude And Occlude F Dentin Tubule Agent.
| Device ID | K082071 |
| 510k Number | K082071 |
| Device Name: | ADPHARMA OCCLUDE AND OCCLUDE F DENTIN TUBULE AGENT |
| Classification | Varnish, Cavity |
| Applicant | ADPHARMA, INC. 415 WEST GOLF ROAD SUITE 57 Arlington Heights, IL 60005 |
| Contact | Vivek Ramana |
| Correspondent | Vivek Ramana ADPHARMA, INC. 415 WEST GOLF ROAD SUITE 57 Arlington Heights, IL 60005 |
| Product Code | LBH |
| CFR Regulation Number | 872.3260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-22 |
| Decision Date | 2008-10-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| G402DENTOCLUDE1 | K082071 | 000 |