The following data is part of a premarket notification filed by The Hygenic Corp. with the FDA for Dental Dam.
| Device ID | K954990 |
| 510k Number | K954990 |
| Device Name: | DENTAL DAM |
| Classification | Dam, Rubber |
| Applicant | THE HYGENIC CORP. 1245 HOME AVE. Akron, OH 44310 |
| Contact | Hank Juske |
| Correspondent | Hank Juske THE HYGENIC CORP. 1245 HOME AVE. Akron, OH 44310 |
| Product Code | EIE |
| CFR Regulation Number | 872.6300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-31 |
| Decision Date | 1996-01-26 |