The following data is part of a premarket notification filed by Reynolds Laboratories with the FDA for Reynolds Bleaching Process.
| Device ID | K790378 |
| 510k Number | K790378 |
| Device Name: | REYNOLDS BLEACHING PROCESS |
| Classification | Heat Source For Bleaching Teeth |
| Applicant | REYNOLDS LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EEG |
| CFR Regulation Number | 872.6475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-02-23 |
| Decision Date | 1979-04-10 |