The following data is part of a premarket notification filed by Centrix, Inc. with the FDA for Senzzzzz Away.
| Device ID | K120176 |
| 510k Number | K120176 |
| Device Name: | SENZZZZZ AWAY |
| Classification | Varnish, Cavity |
| Applicant | CENTRIX, INC. 11234 EL CAMINO REAL STE 200 San Diego, CA 92130 |
| Contact | Linda K Schulz |
| Correspondent | Linda K Schulz CENTRIX, INC. 11234 EL CAMINO REAL STE 200 San Diego, CA 92130 |
| Product Code | LBH |
| CFR Regulation Number | 872.3260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-20 |
| Decision Date | 2012-07-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817051021331 | K120176 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SENZZZZZ AWAY 85239249 4272743 Live/Registered |
Majestic Drug Co. Inc. 2011-02-10 |