FDA 510(k) Application Details - K022150

Device Classification Name Cement, Dental

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510(K) Number K022150
Device Name Cement, Dental
Applicant PENTRON CLINICAL TECHNOLOGIES
53 NORTH PLAINS INDUSTRIAL RD.
WALLINGFORD, CT 06492-0724 US
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Contact ANNMARIE TENERO
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Regulation Number 872.3275

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Classification Product Code EMA
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Date Received 07/02/2002
Decision Date 08/21/2002
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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