FDA 510(k) Application Details - K001309

Device Classification Name Crown And Bridge, Temporary, Resin

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510(K) Number K001309
Device Name Crown And Bridge, Temporary, Resin
Applicant KAY SEE DENTAL MFG. CO.
124 EAST MISSOURI AVE.
KANSAS CITY, MO 64106-1294 US
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Contact CLARK SMITH
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Regulation Number 872.3770

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Classification Product Code EBG
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Date Received 04/25/2000
Decision Date 06/13/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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