The following data is part of a premarket notification filed by Young Dental Manufacturing Co 1, Llc. with the FDA for Rubber Dam Holder.
| Device ID | K781520 |
| 510k Number | K781520 |
| Device Name: | RUBBER DAM HOLDER |
| Classification | Frame, Rubber Dam |
| Applicant | YOUNG DENTAL MANUFACTURING CO 1, LLC. 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 | 1978-09-01 |
| Decision Date | 1978-10-10 |