FDA 510(k) Application Details - K233273

Device Classification Name Material, Tooth Shade, Resin

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510(K) Number K233273
Device Name Material, Tooth Shade, Resin
Applicant Prevest Denpro Limited
Unit II, Export Promotion Industrial Park
Bari Brahmana 181133 IN
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Contact Atul Modi
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Regulation Number 872.3690

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Classification Product Code EBF
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Date Received 09/29/2023
Decision Date 11/27/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K233273


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