FDA 510(k) Application Details - K202673

Device Classification Name Powder, Porcelain

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510(K) Number K202673
Device Name Powder, Porcelain
Applicant Dongguan Xiangtong Co., Ltd.
No.4, Tech 9th Rd, Hi-Tech Industrial Development Zone,
Songshan Lake
Dongguan 523808 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 09/15/2020
Decision Date 12/10/2020
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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