FDA 510(k) Application Details - K994261

Device Classification Name Cement, Dental

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510(K) Number K994261
Device Name Cement, Dental
Applicant ULTRADENT PRODUCTS, INC.
505 WEST 10200 SOUTH
SOUTH JORDAN, UT 84095 US
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Contact SCOTT E MOORE
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Regulation Number 872.3275

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Classification Product Code EMA
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Date Received 12/17/1999
Decision Date 02/02/2000
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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