FDA 510(k) Application Details - K021457

Device Classification Name Crown And Bridge, Temporary, Resin

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510(K) Number K021457
Device Name Crown And Bridge, Temporary, Resin
Applicant PENTRON CORP.
53 NORTH PLAINS INDUSTRIAL RD.
P.O. BOX 724
WALLINGFORD, CT 06492 US
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Contact ANNMARIE TENERO
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Regulation Number 872.3770

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Classification Product Code EBG
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Date Received 05/06/2002
Decision Date 08/01/2002
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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