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FDA 510(k) Application Details - K172398
Device Classification Name
More FDA Info for this Device
510(K) Number
K172398
Device Name
DENTCA DENTURE Teeth
Applicant
DENTCA, INC.
357 Van Ness Way, Suite 250
Torrance, CA 90501 US
Other 510(k) Applications for this Company
Contact
Jason Lee
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PZY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/08/2017
Decision Date
11/22/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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