The following data is part of a premarket notification filed by Hygienic Dental Mfg., Co., The with the FDA for Hygienic Rubber Dam Frame.
| Device ID | K780746 |
| 510k Number | K780746 |
| Device Name: | HYGIENIC RUBBER DAM FRAME |
| Classification | Frame, Rubber Dam |
| Applicant | HYGIENIC DENTAL MFG., CO., THE 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EJE |
| CFR Regulation Number | 872.6300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-04-13 |
| Decision Date | 1978-05-12 |