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
|
|
Correspondent Contact |
STUART R GOLDMAN |
Regulation Number | 872.6660
|
Classification Product Code |
|
Subsequent Product Code |
|
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
|
|
|