The following data is part of a premarket notification filed by Ivoclar Vivadent Ag with the FDA for Fluor Protector S.
| Device ID | K131487 |
| 510k Number | K131487 |
| Device Name: | FLUOR PROTECTOR S |
| Classification | Varnish, Cavity |
| Applicant | IVOCLAR VIVADENT AG 175 PINEVIEW DR. Amherst, NY 14228 |
| Contact | Donna M Hartnett |
| Correspondent | Donna M Hartnett IVOCLAR VIVADENT AG 175 PINEVIEW DR. Amherst, NY 14228 |
| Product Code | LBH |
| CFR Regulation Number | 872.3260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-23 |
| Decision Date | 2014-10-08 |
| Summary: | summary |