The following data is part of a premarket notification filed by Sylphar N.v. with the FDA for Remesense For Sensitive Teeth.
| Device ID | K122708 |
| 510k Number | K122708 |
| Device Name: | REMESENSE FOR SENSITIVE TEETH |
| Classification | Varnish, Cavity |
| Applicant | SYLPHAR N.V. PIAZZA ALBANIA 10 Rome, Italy, IT 00153 |
| Contact | Roger Gray |
| Correspondent | Roger Gray SYLPHAR N.V. PIAZZA ALBANIA 10 Rome, Italy, IT 00153 |
| Product Code | LBH |
| CFR Regulation Number | 872.3260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-04 |
| Decision Date | 2013-01-14 |
| Summary: | summary |