FDA 510(k) Application Details - K241715

Device Classification Name Powder, Porcelain

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510(K) Number K241715
Device Name Powder, Porcelain
Applicant Aidite (Qinhuangdao) Technology Co., Ltd.
No.9 Dushan Rd, Economic and Technological Development Zone
Qinhuangdao 066004 CN
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Contact Jinzhong Xu
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Regulation Number 872.6660

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Classification Product Code EIH
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Date Received 06/14/2024
Decision Date 07/12/2024
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 K241715


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