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FDA 510(k) Application Details - K983461
Device Classification Name
Resin, Denture, Relining, Repairing, Rebasing
More FDA Info for this Device
510(K) Number
K983461
Device Name
Resin, Denture, Relining, Repairing, Rebasing
Applicant
TRANS-ATLANTIC DENTAL
46 ARCTIC PKWY.
TRENTON, NJ 08638-3041 US
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Contact
CAROLINE M ZALESKI
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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
10/01/1998
Decision Date
04/13/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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