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FDA 510(k) Application Details - K100145
Device Classification Name
Powder, Porcelain
More FDA Info for this Device
510(K) Number
K100145
Device Name
Powder, Porcelain
Applicant
A&E BIOCERAMIC CO., LTD.
NO. 10, LANE 273, SEC. 4
CHANGING RD., LUZHU TOWHSHIP
TAOYUAN COUNTY 338 TW
Other 510(k) Applications for this Company
Contact
MARZ CHIU
Other 510(k) Applications for this Contact
Regulation Number
872.6660
More FDA Info for this Regulation Number
Classification Product Code
EIH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/19/2010
Decision Date
04/13/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Statement
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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