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 |