FDA 510(k) Application Details - K241226

Device Classification Name Crown And Bridge, Temporary, Resin

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510(K) Number K241226
Device Name Crown And Bridge, Temporary, Resin
Applicant Dreve Denatmid GmbH
Max-Planck-Strasse 31
59423 Unna
Nordrhein-Westfalen DE
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Contact Anke Hⁿttenbrauck
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Regulation Number 872.3770

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Classification Product Code EBG
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Date Received 05/02/2024
Decision Date 05/31/2024
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

FDA Source Information for K241226


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