• 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 Liner, Cavity, Calcium Hydroxide
510(k) Number K010176
Device Name CALEX CONDITIONER
Applicant
STEPHEN M. KORAL, D.M.D.
2006 BROADWAY
BOULDER,  CO  80302
Applicant Contact STEPHEN M KORAL
Correspondent
STEPHEN M. KORAL, D.M.D.
2006 BROADWAY
BOULDER,  CO  80302
Correspondent Contact STEPHEN M KORAL
Regulation Number872.3250
Classification Product Code
EJK  
Date Received01/18/2001
Decision Date 03/27/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-