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FDA 510(k) Application Details - K183079
Device Classification Name
Abutment, Implant, Dental, Endosseous
More FDA Info for this Device
510(K) Number
K183079
Device Name
Abutment, Implant, Dental, Endosseous
Applicant
Dentsply Sirona Inc.
221 West Philadelphia Street, Suite 60W
York, PA 17401 US
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Contact
Karl Nittinger
Other 510(k) Applications for this Contact
Regulation Number
872.3630
More FDA Info for this Regulation Number
Classification Product Code
NHA
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More FDA Info for this Product Code
Date Received
11/05/2018
Decision Date
07/10/2019
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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