FDA.reportPublic FDA data

ORTHOMETRIC ULTRA-P BRACKET

Primary DI
07898488906395
Brand
ORTHOMETRIC ULTRA-P BRACKET
Company
ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA
Model
10.46.2214
Catalog number
10.46.2214
Device description
"SELF LIGATING BRACKET ORTHOCLIP SLB ULTRA-P- ROTH 0.022""U 45 R W/ HOOK"
Published
2022-09-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
EJFBracket, Metal, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJFBracket, Metal, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07898488906395PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07898488906395078984889063957898488906395

GMDN Terms#

Term, Definition table
TermDefinition
Self-ligating orthodontic bracketA 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 has an integral fixation clip, typically made of a polymer with a metal hinge, to retain the archwire (self-ligating) within a metal insert slot. 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

Regulatory Flags#

DUNS number
898330003
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07898488900621KIT THERMO 35° WIRES - ROUNDS + RECTANGULARS - 100 TENS51.35.28012026-05-27
07898488905107WEINGART PLIER W/OUT WIDIA75.01.01212026-05-27
07898488905190INSTRUMENT FOR ICERAM SLB BRACKET75.00.00012026-05-27
07898488907217TUBE CONVERSION PLIER – 400375.01.05152026-05-27
07898488909945ELASTIC LIGATURE APPLICATOR/REMOVER75.00.00042026-05-27
07908470705735PLIER ANGLE W/ WIDIA AND CUTTING (139)75.01.11552026-05-27
07908470705803TORQUE PLIER SHORT (442)75.01.00232026-05-27
07908470707135ORTHODONTIC ELASTIC INTRAORAL - LATEX HEAVY 1/4 - SILMET60.01.20082026-05-27
07908470707142ORTHODONTIC ELASTIC INTRAORAL - LATEX HEAVY 3/16 - SILMET60.01.20072026-05-27
07908470707159ORTHODONTIC ELASTIC INTRAORAL - LATEX MEDIUM 1/4 - SILMET60.01.10082026-05-27
07908470707166ORTHODONTIC ELASTIC INTRAORAL - LATEX MEDIUM 3/16 - SILMET60.01.10072026-05-27
07908611200129PLIER FOR LONG TORQUE (442)75.01.08062026-05-27
07908611200822TUNGSTEN CARBIDE CUTTING BUR CC136FX LOW SPEED - 1UN75.80.10062026-05-27
07908611204325ANGULAR BRACKET REMOVAL PLIER75.01.00042026-05-27
07908611205964ORTHOMETRIC ELASTIC STICK LIGATURE - ORANGE60.03.10562026-05-27
07908611207944KIT ELASTOMERIC - STICK LIGATURES - 23 COLORS60.03.29102026-05-27
07908611207951KIT ELASTOMERIC - ELASTIC CHAIN 1,5M - MEDIUM - 23 COLORS60.05.29102026-05-27
07908611207968KIT ELASTOMERIC - MODULAR LIGATURE 22 TIES - 10 COLORS60.06.29102026-05-27
07908611210654ORTHOMETRIC ELASTIC CHAIN 1.5M - LONG - CARIBBEAN BLUE60.05.70592026-05-27
07908611210715ORTHOMETRIC ELASTIC STICK LIGATURE - CORAL60.03.10572026-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10190886271025G&H ORTHODONTICS ®G & H Wire Company, Inc.EJF2026-02-27
10190886271032G&H ORTHODONTICS ®G & H Wire Company, Inc.EJF2026-02-27
10190886271049G&H ORTHODONTICS ®G & H Wire Company, Inc.EJF2026-02-27
10190886271056G&H ORTHODONTICS ®G & H Wire Company, Inc.EJF2026-02-27
10190886271063G&H ORTHODONTICS ®G & H Wire Company, Inc.EJF2026-02-27
10190886271070G&H ORTHODONTICS ®G & H Wire Company, Inc.EJF2026-02-27
10190886271087G&H ORTHODONTICS ®G & H Wire Company, Inc.EJF2026-02-27
10190886271094G&H ORTHODONTICS ®G & H Wire Company, Inc.EJF2026-02-27
10190886271100G&H ORTHODONTICS ®G & H Wire Company, Inc.EJF2026-02-27
10190886271117G&H ORTHODONTICS ®G & H Wire Company, Inc.EJF2026-02-27
07908611216748METAL BRACKET U-CLIP PASSIVE ROTH 0,022 - 1 SETORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-01-12
07908611216755METAL BRACKET U-CLIP PASSIVE ROTH 0.022 U1R (11) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-01-12
07908611216762METAL BRACKET U-CLIP PASSIVE ROTH 0.022 U2R (12) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-01-12
07908611216779METAL BRACKET U-CLIP PASSIVE ROTH 0.022 U3R (13) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-01-12
07908611216786METAL BRACKET U-CLIP PASSIVE ROTH 0.022 U45R (14/15) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-01-12
07908611216793METAL BRACKET U-CLIP PASSIVE ROTH 0.022 U1L (21) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-01-12
07908611216809METAL BRACKET U-CLIP PASSIVE ROTH 0.022 U2L (22) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-01-12
07908611216816METAL BRACKET U-CLIP PASSIVE ROTH 0.022 U3L (23) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-01-12
07908611216823METAL BRACKET U-CLIP PASSIVE ROTH 0.022 U45L (24/25) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-01-12
07908611216830METAL BRACKET U-CLIP PASSIVE ROTH 0.022 L12RL (31/32/41/42) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-01-12
07908611216847METAL BRACKET U-CLIP PASSIVE ROTH 0.022 L3L (33) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-01-12
07908611216854METAL BRACKET U-CLIP PASSIVE ROTH 0.022 L4L (34) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-01-12
07908611216861METAL BRACKET U-CLIP PASSIVE ROTH 0.022 L5L (35) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-01-12
07908611216878METAL BRACKET U-CLIP PASSIVE ROTH 0.022 L3R (43) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-01-12
07908611216885METAL BRACKET U-CLIP PASSIVE ROTH 0.022 L4R (44) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-01-12
07908611216892METAL BRACKET U-CLIP PASSIVE ROTH 0.022 L5R (45) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-01-12
07908611216908METAL BRACKET U-CLIP HYBRID ROTH 0.022 - 1 SETORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-01-12
07908611216939METAL BRACKET U-CLIP PASSIVE MBT 0,022 - 1 SETORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-01-12
07908611216946METAL BRACKET U-CLIP PASSIVE MBT 0.022 U1R (11) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-01-12
07908611216953METAL BRACKET U-CLIP PASSIVE MBT 0.022 U2R (12) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-01-12