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, Orthodontic
510(k) Number K122069
Device Name STORM MINI SCREW
Applicant
Lancer Orthodontics, Inc.
2330 Cousteau Court
Vista,  CA  92081
Applicant Contact LARRY WALKER
Correspondent
Lancer Orthodontics, Inc.
2330 Cousteau Court
Vista,  CA  92081
Correspondent Contact LARRY WALKER
Regulation Number872.3640
Classification Product Code
OAT  
Date Received07/16/2012
Decision Date 04/11/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-