• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name material, tooth shade, resin
510(k) Number K121735
Device Name FIBER DISK AND BLOCK PERMANENT, TRINIA
Original Applicant
BIOLOREN SRL
via alessandro volta 59
saronno, va,  IT 21047
Original Contact ratti andrea
Regulation Number872.3690
Classification Product Code
EBF  
Date Received06/13/2012
Decision Date 02/21/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-