FDA 510(k) Application Details - K242277

Device Classification Name Material, Tooth Shade, Resin

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510(K) Number K242277
Device Name Material, Tooth Shade, Resin
Applicant SprintRay Inc.
2710 Media Center Drive, Suite 100A
Los Angeles, CA 90065 US
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Contact Sara Moghtadernejad
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Regulation Number 872.3690

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Classification Product Code EBF
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Date Received 08/01/2024
Decision Date 10/01/2024
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 K242277


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