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 K935625
Device Name ALPHADENT LIGHT ACTIVATED ORTHODONTIC ADHESIVE BONDING SYSTEM WITH FLUORIDE
Applicant
Wallace A. Erickson & Co.
1920 N. Clybourn Ave.
Chicago,  IL  60614
Applicant Contact GEORGE NICOLAE
Correspondent
Wallace A. Erickson & Co.
1920 N. Clybourn Ave.
Chicago,  IL  60614
Correspondent Contact GEORGE NICOLAE
Regulation Number872.3750
Classification Product Code
DYH  
Date Received11/22/1993
Decision Date 08/10/1994
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
-
-