DENTAL DIGITAL X-RAY IMAGING SYSTEM


Device Classification Name

system,x-ray,extraoral source,digital

510(k) Number K073365
Device Name DENTAL DIGITAL X-RAY IMAGING SYSTEM
Applicant
VATECH CO., LTD.
30 northport road
sound beach, 
NY 
11789

Applicant Contact stephen t mlcoch
Correspondent
VATECH CO., LTD.
30 northport road
sound beach, 
NY 
11789

Correspodent Contact stephen t mlcoch
Regulation Number 872.1800
Classification Product Code
MUH  
Date Received 11/30/2007
Decision Date 04/08/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No