FDA 510(k) Application Details - K060334

Device Classification Name Cement, Dental

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510(K) Number K060334
Device Name Cement, Dental
Applicant ULTRADENT PRODUCTS, INC.
505 WEST 10200 SOUTH
SOUTH JORDAN, UT 84095 US
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Contact TAMMY LAVERY
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Regulation Number 872.3275

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Classification Product Code EMA
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Date Received 02/09/2006
Decision Date 02/23/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Statement
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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