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 K801779
Device Name OXYDENTAL ZINC OXIDE EUGENOL(ZOE)CEMENT
Applicant
Oxy Dental Products, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Oxy Dental Products, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number872.3275
Classification Product Code
EMB  
Date Received07/28/1980
Decision Date 08/07/1980
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
-
-