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510(k) Data Aggregation
K Number
K231635Device Name
A-Line Advanced
Manufacturer
Biocetec Co., Ltd
Date Cleared
2023-06-06
(1 days)
Product Code
NJM
Regulation Number
872.5470Why did this record match?
Applicant Name (Manufacturer) :
Biocetec Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A-Line Advanced orthodontic ceramic bracket is intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.
Device Description
This orthodontic bracket is made of polycrystalline ceramic and is used for the treatment of malocclusion. It is designed to be attached to the surface of patients' teeth and be connected to the orthodontic wire in order to apply physical pressure on the tooth movement. Each model differs in size and dimension, color identification as they are attached to the tooth surface corresponding to 20 of the 28 permanent teeth.
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K Number
K163467Device Name
C-Line Orthodontic Ceramic Bracket
Manufacturer
BIOCETEC CO., LTD
Date Cleared
2017-06-14
(184 days)
Product Code
NJM
Regulation Number
872.5470Why did this record match?
Applicant Name (Manufacturer) :
BIOCETEC CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
C-LineTM orthodontic ceramic bracket is intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position
Device Description
C-Line ™ orthodontic ceramic brackets are intended to be bonded to a tooth to apply pressure to a tooth to alter its position. C-Line ™ orthodontic ceramic brackets consist of a translucent alumina body and a bonding base. The bracket's color marking and cords indicates the bracket positioning and facilitate bracket identification.
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