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FDA 510(k) Application Details - K133071
Device Classification Name
Material, Impression
More FDA Info for this Device
510(K) Number
K133071
Device Name
Material, Impression
Applicant
RIZHAO HUGE DENTAL INDUSTRY CO., LTD
3500 SOUTH DUPONT HIGHWAY
DOVER, DE 19901 US
Other 510(k) Applications for this Company
Contact
LEON LU
Other 510(k) Applications for this Contact
Regulation Number
872.3660
More FDA Info for this Regulation Number
Classification Product Code
ELW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/30/2013
Decision Date
05/28/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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