The following data is part of a premarket notification filed by Young Dental Manufacturing Co 1, Llc. with the FDA for Oral-b 5% Sodium Fluoride Varnish.
| Device ID | K153334 |
| 510k Number | K153334 |
| Device Name: | Oral-B 5% Sodium Fluoride Varnish |
| Classification | Varnish, Cavity |
| Applicant | YOUNG DENTAL MANUFACTURING CO 1, LLC. 13705 SHORELINE CT. EAST Earth City, MO 63045 |
| Contact | Sarah Moore |
| Correspondent | Sarah Moore YOUNG DENTAL MANUFACTURING CO 1, LLC. 13705 SHORELINE CT. EAST Earth City, MO 63045 |
| Product Code | LBH |
| CFR Regulation Number | 872.3260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-19 |
| Decision Date | 2016-05-20 |
| Summary: | summary |