FDA 510(k) Application Details - K024343

Device Classification Name Agent, Polishing, Abrasive, Oral Cavity

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510(K) Number K024343
Device Name Agent, Polishing, Abrasive, Oral Cavity
Applicant USBIOMATERIALS CORP.
13709 PROGRESS BLVD.
#23
ALACHUA, FL 32615 US
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Contact DAVID C GREENSPAN
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Regulation Number 872.6030

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Classification Product Code EJR
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Date Received 12/27/2002
Decision Date 07/11/2003
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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