PIEZOTOME SOLO


Device Classification Name

drill, bone, powered

510(k) Number K112188
Device Name PIEZOTOME SOLO
Applicant
SATELEC – ACTEON, INC.
124 gaither dr., suite 140
mount laurel, 
NJ 
08054

Applicant Contact rick rosati
Correspondent
SATELEC – ACTEON, INC.
124 gaither dr., suite 140
mount laurel, 
NJ 
08054

Correspodent Contact rick rosati
Regulation Number 872.4120
Classification Product Code
DZI  
Date Received 07/29/2011
Decision Date 02/03/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No