SAMSUNG 10DR IMPLANT SYSTEM


information about

Device Classification Name

unit, x-ray, extraoral with timer

510(k) Number K002062
Device Name SAMSUNG 10DR IMPLANT SYSTEM
Original Applicant
SAMSUNG SDS CO., LTD
2001 east oakshores dr.
aubrey, 
TX 
76227

Original Contact carl alletto
Regulation Number 872.1800
Classification Product Code
EHD  
Date Received 07/06/2000
Decision Date 11/09/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Radiology

Type Traditional
Reviewed by Third Party No

Combination Product

No