SUPER PORCELAIN EX-3 UNIVERSAL OPAQUE


Device Classification Name

powder, porcelain

510(k) Number K111107
Device Name SUPER PORCELAIN EX-3 UNIVERSAL OPAQUE
Applicant
NORITAKE CO., INC.
700 12 street, n.w.,
suite 1100
washington, 
DC 
20005

Applicant Contact ivan wasserman
Correspondent
NORITAKE CO., INC.
700 12 street, n.w.,
suite 1100
washington, 
DC 
20005

Correspodent Contact ivan wasserman
Regulation Number 872.6660
Classification Product Code
EIH  
Date Received 04/20/2011
Decision Date 06/30/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No