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 Liner, Cavity, Calcium Hydroxide
510(k) Number K841910
Device Name KERR SEALAPEX ROOT CANAL SEALER
Applicant
Sybron Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Sybron Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number872.3250
Classification Product Code
EJK  
Date Received05/09/1984
Decision Date 07/13/1984
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
-
-