MINI LED AUTOFOCUS


Device Classification Name

activator, ultraviolet, for polymerization

510(k) Number K072181
Device Name MINI LED AUTOFOCUS
Applicant
SATELEC
124 gaither drive
suite 140
mt. laurel, 
NJ 
08054

Applicant Contact steve salesky
Correspondent
SATELEC
124 gaither drive
suite 140
mt. laurel, 
NJ 
08054

Correspodent Contact steve salesky
Regulation Number 872.6070
Classification Product Code
EBZ  
Date Received 08/06/2007
Decision Date 09/19/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No