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FDA 510(k) Application Details - K142118
Device Classification Name
Abutment, Implant, Dental, Endosseous
More FDA Info for this Device
510(K) Number
K142118
Device Name
Abutment, Implant, Dental, Endosseous
Applicant
PRISMATIK DENTALCRAFT, INC.
2212 DUPONT DRIVE
SUITE P
IRVINE, CA 92627 US
Other 510(k) Applications for this Company
Contact
BRANDON SHEPARD
Other 510(k) Applications for this Contact
Regulation Number
872.3630
More FDA Info for this Regulation Number
Classification Product Code
NHA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/04/2014
Decision Date
11/25/2014
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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