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FDA 510(k) Application Details - K210115
Device Classification Name
Adhesive, Bracket And Tooth Conditioner, Resin
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510(K) Number
K210115
Device Name
Adhesive, Bracket And Tooth Conditioner, Resin
Applicant
Largent Health, LLC
3698 Largent Way NW, Suite 101
Marietta, GA 30064 US
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Contact
Kirk Kimmerling
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Regulation Number
872.3750
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Classification Product Code
DYH
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More FDA Info for this Product Code
Date Received
01/19/2021
Decision Date
07/29/2021
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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