The following data is part of a premarket notification filed by Sopro with the FDA for Soprocare.
| Device ID | K121685 |
| 510k Number | K121685 |
| Device Name: | SOPROCARE |
| Classification | Laser, Fluorescence Caries Detection |
| Applicant | SOPRO 124 GAITHER DRIVE SUITE 140 Mt. Laurel, NJ 08054 |
| Contact | Rick Rosati |
| Correspondent | Rick Rosati SOPRO 124 GAITHER DRIVE SUITE 140 Mt. Laurel, NJ 08054 |
| Product Code | NBL |
| CFR Regulation Number | 872.1745 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-07 |
| Decision Date | 2013-03-12 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SOPROCARE 79116864 4296909 Live/Registered |
SOPRO 2012-07-16 |