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 K040881
Device Name METACRYL
Applicant
GREAT LAKES ORTHODONTICS, LTD.
200 COOPER AVE.
P.O. BOX 5111
TONAWANDA,  NY  14151 -5111
Applicant Contact MARK LAUREN
Correspondent
GREAT LAKES ORTHODONTICS, LTD.
200 COOPER AVE.
P.O. BOX 5111
TONAWANDA,  NY  14151 -5111
Correspondent Contact MARK LAUREN
Regulation Number872.3760
Classification Product Code
EBI  
Date Received04/05/2004
Decision Date 05/25/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-