ELITE MONOPHASE


Device Classification Name

material, impression

510(k) Number K022653
Device Name ELITE MONOPHASE
Original Applicant
ZHERMACK S.P.A.
19379 blue lake loop
bend, 
OR 
97702

Original Contact gerald w shipps
Regulation Number 872.3660
Classification Product Code
ELW  
Date Received 08/09/2002
Decision Date 10/28/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No