COLORISE RIGID


Device Classification Name

material, impression

510(k) Number K081084
Device Name COLORISE RIGID
Applicant
ZHERMACK S.P.A.
19379 blue lake loop
bend, 
OR 
97702

Applicant Contact gerald w shipps
Correspondent
ZHERMACK S.P.A.
19379 blue lake loop
bend, 
OR 
97702

Correspodent Contact gerald w shipps
Regulation Number 872.3660
Classification Product Code
ELW  
Date Received 04/16/2008
Decision Date 05/14/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No