PIEZOSURGERY TOUCH


Device Classification Name

drill, bone, powered

510(k) Number K122322
Device Name PIEZOSURGERY TOUCH
Applicant
MECTRON S.P.A.
piazza albania 10
rome, 

IT

00153

Applicant Contact roger gray
Correspondent
MECTRON S.P.A.
piazza albania 10
rome, 

IT

00153

Correspodent Contact roger gray
Regulation Number 872.4120
Classification Product Code
DZI  
Subsequent Product Code
ELC  
Date Received 08/01/2012
Decision Date 12/06/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No