The following data is part of a premarket notification filed by Oral-b Laboratories with the FDA for Oral-b Ultrafloss With Flluoride.
| Device ID | K943157 |
| 510k Number | K943157 |
| Device Name: | ORAL-B ULTRAFLOSS WITH FLLUORIDE |
| Classification | Floss, Dental |
| Applicant | ORAL-B LABORATORIES ONE LAGOON DR. Redwood City, CA 94065 |
| Contact | Sharon Snyder |
| Correspondent | Sharon Snyder ORAL-B LABORATORIES ONE LAGOON DR. Redwood City, CA 94065 |
| Product Code | JES |
| CFR Regulation Number | 872.6390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-01 |
| Decision Date | 1995-04-27 |