The following data is part of a premarket notification filed by Interdent, Inc. with the FDA for Fastdam.
| Device ID | K972775 |
| 510k Number | K972775 |
| Device Name: | FASTDAM |
| Classification | Dam, Rubber |
| Applicant | INTERDENT, INC. 2230 SOUTH BARRINGTON Los Angeles, CA 90064 |
| Contact | William Grondin |
| Correspondent | William Grondin INTERDENT, INC. 2230 SOUTH BARRINGTON Los Angeles, CA 90064 |
| Product Code | EIE |
| CFR Regulation Number | 872.6300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-24 |
| Decision Date | 1998-02-27 |