• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name varnish, cavity
510(k) Number K120176
Device Name SENZZZZZ AWAY
Applicant
CENTRIX, INC.
11234 EL CAMINO REAL
STE 200
san diego,  CA  92130
Applicant Contact linda k schulz
Correspondent
CENTRIX, INC.
11234 EL CAMINO REAL
STE 200
san diego,  CA  92130
Correspondent Contact linda k schulz
Regulation Number872.3260
Classification Product Code
LBH  
Date Received01/20/2012
Decision Date 07/25/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-