PORTABLE HDX INTRAORAL X-RAY


Device Classification Name

unit, x-ray, extraoral with timer

510(k) Number K021378
Device Name PORTABLE HDX INTRAORAL X-RAY
Original Applicant
DENTALEZ GROUP
1816 colonial village ln.
lancaster, 
PA 
17601

Original Contact deon beck
Regulation Number 872.1800
Classification Product Code
EHD  
Date Received 05/01/2002
Decision Date 06/07/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No