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FDA 510(k) Application Details - K220556
Device Classification Name
System,X-Ray,Extraoral Source,Digital
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510(K) Number
K220556
Device Name
System,X-Ray,Extraoral Source,Digital
Applicant
DentiMax, Inc
4115 E Valley Auto Dr, Suite 101
Mesa, AZ 85298 US
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Contact
David Arnett
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Regulation Number
872.1800
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Classification Product Code
MUH
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More FDA Info for this Product Code
Date Received
02/28/2022
Decision Date
04/13/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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