ELITE GLASS


Device Classification Name

material, impression

510(k) Number K073005
Device Name ELITE GLASS
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 10/24/2007
Decision Date 12/12/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

Type Traditional
Reviewed by Third Party No

Combination Product

No