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FDA 510(k) Application Details - K182672
Device Classification Name
Bracket, Ceramic, Orthodontic
More FDA Info for this Device
510(K) Number
K182672
Device Name
Bracket, Ceramic, Orthodontic
Applicant
GNI Co., LTD
5F 501, 63-12 Dongtancheomdansaneop 1-RO
Hwaseong 18469 KR
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Contact
Duk Soo Kim
Other 510(k) Applications for this Contact
Regulation Number
872.5470
More FDA Info for this Regulation Number
Classification Product Code
NJM
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/26/2018
Decision Date
11/15/2019
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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