• 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 Bracket, Ceramic, Orthodontic
510(k) Number K142729
Device Name Chi Lites Orthodontic Sapphire Bracket
Applicant
PROGRESSIVE TECHNOLOGY, INC.
4130 CITRUS AVE #17
ROCKLIN,  CA  95677
Applicant Contact Shannon Rogers
Correspondent
PROGRESSIVE TECHNOLOGY, INC.
4130 CITRUS AVE #17
ROCKLIN,  CA  95677
Correspondent Contact Shannon Rogers
Regulation Number872.5470
Classification Product Code
NJM  
Date Received09/23/2014
Decision Date 05/15/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-