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, Impression
510(k) Number K954223
Device Name AMERICAN DENTAL PRODUCTS ALGINATE FLAVORING
Applicant
American Dental Products, Inc.
22w246 Sunnyside Rd.
P.O. Box 435
Medinah,  IL  60157
Applicant Contact GEORGE NICOAE
Correspondent
American Dental Products, Inc.
22w246 Sunnyside Rd.
P.O. Box 435
Medinah,  IL  60157
Correspondent Contact GEORGE NICOAE
Regulation Number872.3660
Classification Product Code
ELW  
Date Received09/11/1995
Decision Date 09/29/1995
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
-
-