Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 powder, porcelain
510(k) Number K130924
Device Name BRUXZIR SHADED
Applicant
PRISMATIK DENTALCRAFT, INC.
2212 DUPONT DR.,
SUITE JJK
IRVINE,  CA  92612
Applicant Contact ARMIN ZEHTABCHI
Correspondent
PRISMATIK DENTALCRAFT, INC.
2212 DUPONT DR.,
SUITE JJK
IRVINE,  CA  92612
Correspondent Contact ARMIN ZEHTABCHI
Regulation Number872.6660
Classification Product Code
EIH  
Date Received04/03/2013
Decision Date 05/16/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-