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 Resin, Denture, Relining, Repairing, Rebasing
510(k) Number K083479
Device Name BIOCRYL X
Applicant
Great Lakes Orthodontics, Ltd.
200 Cooper Ave.Dr.
Tonawanda,  NY  14150
Applicant Contact MARK LAUREN
Correspondent
Great Lakes Orthodontics, Ltd.
200 Cooper Ave.Dr.
Tonawanda,  NY  14150
Correspondent Contact MARK LAUREN
Regulation Number872.3760
Classification Product Code
EBI  
Date Received11/24/2008
Decision Date 02/27/2009
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
-
-