FDA.reportPublic FDA data

MISO

Primary DI
08800022201506
Brand
MISO
Company
HT Co., Ltd.
Model
MBS181-553
Catalog number
MBS181-553 W/Hook
Device description
The MISO bracket is indicated for orthodontic movement of natural teeth
Published
2017-03-11
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
08800022212922PackageGS15In Commercial Distribution
08800022201506PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800022212922088000222129228800022212922
08800022201506088000222015068800022201506

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
1
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
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
08800022212861MISOMB181-355Roth 018 LR5H2017-02-25

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