The following data is part of a premarket notification filed by Remedent Nv with the FDA for Remesense.
| Device ID | K082594 |
| 510k Number | K082594 |
| Device Name: | REMESENSE |
| Classification | Varnish, Cavity |
| Applicant | REMEDENT NV 220 RIVER ROAD Claremont, NH 03743 |
| Contact | William Greenrose |
| Correspondent | William Greenrose REMEDENT NV 220 RIVER ROAD Claremont, NH 03743 |
| Product Code | LBH |
| CFR Regulation Number | 872.3260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-08 |
| Decision Date | 2009-03-19 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() REMESENSE 79084055 3950099 Live/Registered |
Sylphar, naamloze vennootschap 2010-03-19 |