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 Zinc Oxide Eugenol
510(k) Number K862745
Device Name EUGENOL USP
Applicant
E&D Dental Manufacturing Co.
6 Hoffman Place
Hillside,  NJ  07205
Applicant Contact ED SPEHAR
Correspondent
E&D Dental Manufacturing Co.
6 Hoffman Place
Hillside,  NJ  07205
Correspondent Contact ED SPEHAR
Regulation Number872.3275
Classification Product Code
EMB  
Date Received07/21/1986
Decision Date 07/31/1986
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
-
-