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510(k) K180952

Ceramic Bracket by Mem Dental Technology Co., Ltd. — Product Code NJM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 2019
Date Received
April 11, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bracket, Ceramic, Orthodontic
Device Class
Class II
Regulation Number
872.5470
Review Panel
DE
Submission Type

An orthodontic ceramic bracket is a device composed of ceramic, which is intended to be bonded to a tooth, upon which an orthodontic wire is used to move the tooth to a new position.

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