FDA 510(k) Application Details - K963736

Device Classification Name Resin, Denture, Relining, Repairing, Rebasing

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510(K) Number K963736
Device Name Resin, Denture, Relining, Repairing, Rebasing
Applicant SYBRON DENTAL SPECIALTIES, INC.
1717 WEST COLLINS AVE.
ORANGE, CA 92867 US
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Contact WILLIAM R PIKE
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Regulation Number 872.3760

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Classification Product Code EBI
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Date Received 09/17/1996
Decision Date 12/04/1996
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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