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 Device, Caries Detection
510(k) Number K994368
Device Name AMERICAN DENTAL PRODUCTS CARIES-DETECTOR PLUS
Applicant
AMERICAN DENTAL PRODUCTS, INC.
603-B COUNTRY CLUB DR.
BENSENVILLE,  IL  60106 -1329
Applicant Contact GEORGE NICOLAE
Correspondent
AMERICAN DENTAL PRODUCTS, INC.
603-B COUNTRY CLUB DR.
BENSENVILLE,  IL  60106 -1329
Correspondent Contact GEORGE NICOLAE
Regulation Number872.1740
Classification Product Code
LFC  
Date Received12/27/1999
Decision Date 03/14/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-