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510(k) K141104

TRUKLEAR BRACKET by Ajw Technology Consultants, Inc. — Product Code NJM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 2014
Date Received
April 29, 2014
Clearance Type
Special
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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