AIDITE ZIRCONIA DENTAL CERAMICS


Device Classification Name

powder, porcelain

510(k) Number K111291
Device Name AIDITE ZIRCONIA DENTAL CERAMICS
Applicant
QINHUANGDAO AIDITE HIGH-TECHNICAL CERAMICS CO, LTD
611 west 5th street
third floor
austin, 
TX 
78701

Applicant Contact stuart r goldman
Correspondent
QINHUANGDAO AIDITE HIGH-TECHNICAL CERAMICS CO, LTD
611 west 5th street
third floor
austin, 
TX 
78701

Correspodent Contact stuart r goldman
Regulation Number 872.6660
Classification Product Code
EIH  
Subsequent Product Code
ELL  
Date Received 05/06/2011
Decision Date 07/20/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No