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 Unit, Operative Dental
510(k) Number K894759
Device Name ALLPAC(TM) MATERIAL
Applicant
Barrier Concepts, Inc.
Post Office Box 11421
Columbia,  SC  29211
Applicant Contact C HASTEROK
Correspondent
Barrier Concepts, Inc.
Post Office Box 11421
Columbia,  SC  29211
Correspondent Contact C HASTEROK
Regulation Number872.6640
Classification Product Code
EIA  
Date Received07/27/1989
Decision Date 10/13/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-