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FDA 510(k) Application Details - K170044
Device Classification Name
Abutment, Implant, Dental, Endosseous
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510(K) Number
K170044
Device Name
Abutment, Implant, Dental, Endosseous
Applicant
PRISMATIK DENTALCRAFT, INC.
2212 DUPONT DR.
IRVINE, CA 92612 US
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Contact
MARIA E. WAGNER
Other 510(k) Applications for this Contact
Regulation Number
872.3630
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Classification Product Code
NHA
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More FDA Info for this Product Code
Date Received
01/05/2017
Decision Date
06/06/2017
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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