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FDA 510(k) Application Details - K220680
Device Classification Name
Resin, Denture, Relining, Repairing, Rebasing
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510(K) Number
K220680
Device Name
Resin, Denture, Relining, Repairing, Rebasing
Applicant
Shandong Huge Dental Material Corporation
No. 68 Shanhai Road, Donggang District
Rizhao City 276800 CN
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Contact
Maggie Zheng
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Regulation Number
872.3760
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Classification Product Code
EBI
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More FDA Info for this Product Code
Date Received
03/08/2022
Decision Date
08/12/2022
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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