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 K020648
Device Name GRIDLOCK 195 ADHESIVE
Applicant
Allodex Systems
10195 E. Wethersfield Rd.
Scottsdale,  AZ  85260
Applicant Contact MELVYN A STEINBERG
Correspondent
Allodex Systems
10195 E. Wethersfield Rd.
Scottsdale,  AZ  85260
Correspondent Contact MELVYN A STEINBERG
Regulation Number872.3750
Classification Product Code
DYH  
Date Received02/28/2002
Decision Date 05/01/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-