SOPROCARE


Device Classification Name

laser,fluorescence caries detection

510(k) Number K121685
Device Name SOPROCARE
Applicant
SOPRO
124 gaither drive
suite 140
mt. laurel, 
NJ 
08054

Applicant Contact rick rosati
Correspondent
SOPRO
124 gaither drive
suite 140
mt. laurel, 
NJ 
08054

Correspodent Contact rick rosati
Regulation Number 872.1745
Classification Product Code
NBL  
Subsequent Product Code
NYH  
Date Received 06/07/2012
Decision Date 03/12/2013
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No