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 Locator, Root Apex
510(k) Number K992233
Device Name APEX LOCATOR BINGO-1020
Applicant
Dent Corp. Research & Development
7-11 S. Broadway
White Plains,  NY  10601
Applicant Contact DAVID ALBELDA
Correspondent
Dent Corp. Research & Development
7-11 S. Broadway
White Plains,  NY  10601
Correspondent Contact DAVID ALBELDA
Classification Product Code
LQY  
Date Received06/25/1999
Decision Date 11/30/1999
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-