The following data is part of a premarket notification filed by Unicep with the FDA for Microdose Potassium Oxylate.
| Device ID | K924827 |
| 510k Number | K924827 |
| Device Name: | MICRODOSE POTASSIUM OXYLATE |
| Classification | Varnish, Cavity |
| Applicant | UNICEP P.O. BOX 1827 804 AIRPORT WAY Sandpoint, ID 83864 |
| Contact | John Snedden |
| Correspondent | John Snedden UNICEP P.O. BOX 1827 804 AIRPORT WAY Sandpoint, ID 83864 |
| Product Code | LBH |
| CFR Regulation Number | 872.3260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-28 |
| Decision Date | 1993-03-05 |