FDA 510(k) Application Details - K251084

Device Classification Name Powder, Porcelain

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510(K) Number K251084
Device Name Powder, Porcelain
Applicant estetic ceram ag
Landstrasse 109
Triesen 9495 LI
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Contact Micheal Reise
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Regulation Number 872.6660

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Classification Product Code EIH
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Date Received 04/09/2025
Decision Date 06/05/2025
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

FDA Source Information for K251084


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