FDA 510(k) Application Details - K223507

Device Classification Name Activator, Ultraviolet, For Polymerization

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510(K) Number K223507
Device Name Activator, Ultraviolet, For Polymerization
Applicant Good Doctors Co., Ltd.
#208, B-Dong, 283 Bupyeong-Daero, Bupyeong-Gu
Incheon 21315 KR
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Contact Heeseop Lim
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Regulation Number 872.6070

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Classification Product Code EBZ
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Date Received 11/22/2022
Decision Date 08/04/2023
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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