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 K033020
Device Name IMPAK ACRYLIC REPAIR RESIN LIQUID
Applicant
CMP INDUSTRIES LLC.
413 NORTH PEARL ST.
ALBANY,  NY  12207
Applicant Contact WILLIAM REGAN
Correspondent
CMP INDUSTRIES LLC.
413 NORTH PEARL ST.
ALBANY,  NY  12207
Correspondent Contact WILLIAM REGAN
Regulation Number872.3760
Classification Product Code
EBI  
Date Received09/26/2003
Decision Date 12/19/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-