FDA 510(k) Application Details - K221051

Device Classification Name Powder, Porcelain

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510(K) Number K221051
Device Name Powder, Porcelain
Applicant Changsha Honchon Technology Co., LTD
Room 627-628, Building 3th, Jinqiao Market Cluster Area 2,
Purui Road No.1555, Wangcheng
Changsha 410200 CN
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Contact Ling Li
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Regulation Number 872.6660

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Classification Product Code EIH
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Date Received 04/11/2022
Decision Date 07/08/2022
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



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