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FDA 510(k) Application Details - K210259
Device Classification Name
Cement, Dental
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510(K) Number
K210259
Device Name
Cement, Dental
Applicant
Parkell, Inc
300 Executive Drive
Edgewood, NY 11717 US
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Contact
La-Shaunda Joseph
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Regulation Number
872.3275
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Classification Product Code
EMA
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More FDA Info for this Product Code
Date Received
02/01/2021
Decision Date
01/20/2022
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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