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 Adhesive, Bracket And Tooth Conditioner, Resin
510(k) Number K950556
Device Name FUJI ORTHO LC
Applicant
GC America, Inc.
3737 W. 127th St.
Alsip,  IL  60803
Applicant Contact TERRY L JORITZ
Correspondent
GC America, Inc.
3737 W. 127th St.
Alsip,  IL  60803
Correspondent Contact TERRY L JORITZ
Regulation Number872.3750
Classification Product Code
DYH  
Date Received02/07/1995
Decision Date 03/08/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-