ZIRKONDENT


Device Classification Name

powder, porcelain

510(k) Number K080146
Device Name ZIRKONDENT
Applicant
ERGOMETA
144 los flores
aliso viejo, 
CA 
92656

Applicant Contact mike artemov
Correspondent
ERGOMETA
144 los flores
aliso viejo, 
CA 
92656

Correspodent Contact mike artemov
Regulation Number 872.6660
Classification Product Code
EIH  
Date Received 01/22/2008
Decision Date 06/06/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No