FDA 510(k) Application Details - K961708

Device Classification Name Liner, Cavity, Calcium Hydroxide

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510(K) Number K961708
Device Name Liner, Cavity, Calcium Hydroxide
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 872.3250

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Classification Product Code EJK
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Date Received 05/02/1996
Decision Date 05/30/1996
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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