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 K993827
Device Name UFI GEL HARD
Applicant
Voco GmbH
4235 Beaconsfield
Montreal,  CA QC,H4A 2H4
Applicant Contact SHUOJIA DONG
Correspondent
Voco GmbH
4235 Beaconsfield
Montreal,  CA QC,H4A 2H4
Correspondent Contact SHUOJIA DONG
Regulation Number872.3760
Classification Product Code
EBI  
Date Received11/12/1999
Decision Date 01/20/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-