• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections

New Search Back To Search Results
Device Classification Name bracket, plastic, orthodontic
510(k) Number K121524
Device Name INSIGNIA
Original Applicant
1717 west collins avenue
orange,  CA  92867
Original Contact wendy garman
Regulation Number872.5470
Classification Product Code
Subsequent Product Codes
Date Received05/23/2012
Decision Date 08/09/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No