STORM MINI SCREW


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

Correspodent Contact larry walker
Regulation Number 872.3640
Classification Product Code
OAT  
Date Received 07/16/2012
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