The following data is part of a premarket notification filed by Great Lakes Orthodontics, Ltd. with the FDA for Oral Safe.
| Device ID | K832359 |
| 510k Number | K832359 |
| Device Name: | ORAL SAFE |
| Classification | Cleaner, Denture, Mechanical |
| Applicant | GREAT LAKES ORTHODONTICS, LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JER |
| CFR Regulation Number | 872.3530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-07-18 |
| Decision Date | 1983-09-26 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ORAL SAFE 74655008 1956405 Live/Registered |
Great Lakes Orthodontics, Ltd. 1995-04-03 |