FDA 510(k) Application Details - K240912

Device Classification Name Powder, Porcelain

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510(K) Number K240912
Device Name Powder, Porcelain
Applicant Anhui Miisen Intelligence Technology Co., Ltd.
No. 6 Building, South Huoyanshan Road,
Economic Development Zone, Fanchang District
Wuhu 241200 CN
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Contact Charles Shen
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Regulation Number 872.6660

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Classification Product Code EIH
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Date Received 04/03/2024
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 Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K240912


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