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 Implant, Endosseous, Root-Form
510(k) Number K960979
Device Name SCREW EXTRACTION DEVICE AND THREAD CLEANING TAP
Applicant
Steri-Oss, Inc.
22895 Eastpark Dr.
Yorba Linda,  CA  92887
Applicant Contact PAUL GASSER
Correspondent
Steri-Oss, Inc.
22895 Eastpark Dr.
Yorba Linda,  CA  92887
Correspondent Contact PAUL GASSER
Regulation Number872.3640
Classification Product Code
DZE  
Date Received03/11/1996
Decision Date 05/20/1996
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
-
-