FDA 510(k) Application Details - K230410

Device Classification Name Resin, Denture, Relining, Repairing, Rebasing

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510(K) Number K230410
Device Name Resin, Denture, Relining, Repairing, Rebasing
Applicant Dental Direkt GmbH
Industriezentrum 106-108
Spenge 32139 DE
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Contact Patrick Berz
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Regulation Number 872.3760

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Classification Product Code EBI
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Date Received 02/15/2023
Decision Date 06/23/2023
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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