CS 1600 INTRAORAL CAMERA


Device Classification Name

laser,fluorescence caries detection

510(k) Number K111423
Device Name CS 1600 INTRAORAL CAMERA
Applicant
CARESTREAM HEALTH,INC.
1765 the exchange
atlanta, 
GA 
30339

Applicant Contact daniel hoefer
Correspondent
CARESTREAM HEALTH,INC.
1765 the exchange
atlanta, 
GA 
30339

Correspodent Contact daniel hoefer
Regulation Number 872.1745
Classification Product Code
NBL  
Date Received 05/23/2011
Decision Date 03/02/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No