FDA 510(k) Application Details - K000878

Device Classification Name Material, Impression

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510(K) Number K000878
Device Name Material, Impression
Applicant DMG USA, INC.
5 WHITCOMB AVE.
AYER, MA 01432 US
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Contact PAMELA PAPINEAU
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Regulation Number 872.3660

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Classification Product Code ELW
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Date Received 03/20/2000
Decision Date 04/11/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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