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 Material, Tooth Shade, Resin
510(k) Number K954407
Device Name AMERICAN DENTAL PRODUCTS WHITE COMPOSITE RESIN CORE PASTE WITH FLUORIDE
Applicant
American Dental Products, Inc.
22w246 Sunnyside Rd.
P.O. Box 435
Medinah,  IL  60157
Applicant Contact GEORGE NICOLAE
Correspondent
American Dental Products, Inc.
22w246 Sunnyside Rd.
P.O. Box 435
Medinah,  IL  60157
Correspondent Contact GEORGE NICOLAE
Regulation Number872.3690
Classification Product Code
EBF  
Date Received09/20/1995
Decision Date 10/30/1995
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
-
-