The following data is part of a premarket notification filed by Worldwide Dental, Inc. with the FDA for Dental Dam Silicone.
| Device ID | K961472 |
| 510k Number | K961472 |
| Device Name: | DENTAL DAM SILICONE |
| Classification | Dam, Rubber |
| Applicant | WORLDWIDE DENTAL, INC. 100 MAIN ST. SUITE 120 Concord, MA 01742 |
| Contact | Karen K Vaccaro |
| Correspondent | Karen K Vaccaro WORLDWIDE DENTAL, INC. 100 MAIN ST. SUITE 120 Concord, MA 01742 |
| Product Code | EIE |
| CFR Regulation Number | 872.6300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-17 |
| Decision Date | 1996-08-07 |
| Summary: | summary |