FDA.reportPublic FDA data

MISO

Primary DI
08800022212861
Brand
MISO
Company
HT Co., Ltd.
Model
MB181-355
Catalog number
Roth 018 LR5H
Device description
The MISO bracket is indicated for orthodontic movement of natural teeth
Published
2017-02-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
NJMBracket, Ceramic, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NJMBracket, Ceramic, OrthodonticDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800022212878PackageGS15In Commercial Distribution
08800022212861PrimaryGS10
08800022200561Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800022212878088000222128788800022212878
08800022212861088000222128618800022212861
08800022200561088000222005618800022200561

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic bracket, ceramicA ceramic device intended to be bonded to a tooth to hold an orthodontic archwire used to apply pressure to the tooth in order to alter the position of the tooth. It typically has a metal (e.g., stainless steel) insert slot for the archwire, which is held in place with an orthodontic archwire/bracket fixation ring. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.

Sterilization Methods#

Method table
Method
Liquid Chemical

Regulatory Flags#

DUNS number
687793617
Device count
10
Kit
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800022201179MISOMBS221-313MBS221-313w/Hook2017-02-01
08800022201308MISOMBS221-555MBS221-555 w/Hook2017-02-25
08800022201506MISOMBS181-553MBS181-553 W/Hook2017-03-11
08800022201513MISOMBS181-555MBS181-555 W/Hook2017-02-25
08800022212557MISOMB221-304Roth 022 LR42017-02-25
08800022212564MISOMB221-201Roth 022 UL12017-02-25
08800022212588MISOMB181-101Roth 018 UR12017-02-25
08800022212601MISOMB181-102Roth 018 UR22017-02-25
08800022212625MISOMB181-133Roth 018 UR3H2017-02-25
08800022212649MISOMB181-144Roth 018 UR4,5H2017-02-25
08800022212663MISOMB181-201Roth 018 UL12017-02-25
08800022212687MISOMB181-202Roth 018 UL22017-02-25
08800022212700MISOMB181-233Roth 018 UL3H2017-02-25
08800022212724MISOMB181-244Roth 018 UL4,5H2017-02-25
08800022212748MISOMB181-312Roth 018 Lower Anterior2017-02-25
08800022212762MISOMB181-333Roth 018 LR3H2017-02-25
08800022212786MISOMB181-344Roth 018 LR4H2017-02-25
08800022212809MISOMB181-433Roth 018 LL3H2017-02-25
08800022212823MISOMB181-444Roth 018 LL4H2017-02-25
08800022212847MISOMB181-455Roth 018 LL5H2017-02-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07908611210067PROMO KIT ICERAM-P ROTH 0.022ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDANJM2024-04-16
08800046016025VAR-18-301GNI Co.,LtdNJM2022-12-14
08800046016032VAR-18-331GNI Co.,LtdNJM2022-12-14
08800046016049VAR-18-051GNI Co.,LtdNJM2022-12-14
08800046016056VAR-18-501GNI Co.,LtdNJM2022-12-14
08800046016063VAR-18-551GNI Co.,LtdNJM2022-12-14
08800046016070VAR-18-053GNI Co.,LtdNJM2022-12-14
08800046016087VAR-18-503GNI Co.,LtdNJM2022-12-14
08800046016094VAR-18-553GNI Co.,LtdNJM2022-12-14
08800046016100VAR-22-031GNI Co.,LtdNJM2022-12-14
08800046016117VAR-22-301GNI Co.,LtdNJM2022-12-14
08800046016124VAR-22-331GNI Co.,LtdNJM2022-12-14
08800046016131VAR-22-051GNI Co.,LtdNJM2022-12-14
08800046016148VAR-22-501GNI Co.,LtdNJM2022-12-14
08800046016155VAR-22-551GNI Co.,LtdNJM2022-12-14
08800046016162VAR-22-053GNI Co.,LtdNJM2022-12-14
08800046016179VAR-22-503GNI Co.,LtdNJM2022-12-14
08800046016193VAM-18-031GNI Co.,LtdNJM2022-12-14
08800046016209VAM-18-301GNI Co.,LtdNJM2022-12-14
08800046016216VAM-18-331GNI Co.,LtdNJM2022-12-14
08800046016223VAM-18-051GNI Co.,LtdNJM2022-12-14
08800046016230VAM-18-501GNI Co.,LtdNJM2022-12-14
08800046016247VAM-18-551GNI Co.,LtdNJM2022-12-14
08800046016254VAM-18-053GNI Co.,LtdNJM2022-12-14
08800046016261VAM-18-503GNI Co.,LtdNJM2022-12-14
08800046016278VAM-18-553GNI Co.,LtdNJM2022-12-14
08800046016285VAM-22-031GNI Co.,LtdNJM2022-12-14
08800046016292VAM-22-301GNI Co.,LtdNJM2022-12-14
08800046016308VAM-22-331GNI Co.,LtdNJM2022-12-14
08800046016315VAM-22-051GNI Co.,LtdNJM2022-12-14