FDA.report

ORTHOMETRIC ULTRA-P BRACKET

Primary DI
07898488906487
Brand
ORTHOMETRIC ULTRA-P BRACKET
Company
ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA
Model
10.46.2243
Catalog number
10.46.2243
Device description
SELF LIGATING BRACKET ORTHOCLIP SLB ULTRA-P- ROTH 0.022"L 3 R W/ HOOK
Published
2022-09-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
EJFBracket, Metal, Orthodontic

Product Code Classifications

CodeDeviceSpecialtyClass
EJFBracket, Metal, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07898488906487PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07898488906487078984889064877898488906487

GMDN Terms

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

Regulatory Flags

DUNS number
898330003
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
07908611211880ORTHOMETRIC ELASTIC CHAIN 1.5M - SHORT - GREEN60.05.50442025-12-22
07908611211927ORTHOMETRIC ELASTIC CHAIN 1.5M - LONG - GREEN60.05.70442025-12-22
07908611211934ORTHOMETRIC ELASTIC CHAIN 1.5M - LONG - TEAL GREEN60.05.70422025-12-22
07908611211941ORTHOMETRIC ELASTIC CHAIN 1.5M - LONG - EMERALD GREEN60.05.70432025-12-22
07908611211972ORTHOMETRIC ELASTIC CHAIN 4.5M - SHORT - TEAL GREEN60.05.51422025-12-22
07908611211989ORTHOMETRIC ELASTIC CHAIN 4.5M - SHORT - LIME GREEN60.05.51452025-12-22
07908611212054ORTHOMETRIC ELASTIC CHAIN 4.5M - MEDIUM - ACQUA60.05.61412025-12-22
07908611212061ORTHOMETRIC ELASTIC CHAIN 4.5M - MEDIUM - EMERALD GREEN60.05.61432025-12-22
07908611212085ORTHOMETRIC ELASTIC CHAIN 4.5M - MEDIUM - NEON YELLOW60.05.61462025-12-22
07908611212092ORTHOMETRIC ELASTIC CHAIN 4.5M - MEDIUM - LIME GREEN60.05.61452025-12-22
07908611212122ORTHOMETRIC ELASTIC CHAIN 4.5M - LONG - ACQUA60.05.71412025-12-22
07908611212139ORTHOMETRIC ELASTIC CHAIN 4.5M - LONG - LIME GREEN60.05.71452025-12-22
07908611212207ORTHOMETRIC ELASTIC CHAIN 4.5M - LONG - NEON YELLOW60.05.71462025-12-22
07908611212740ORTHOMETRIC ELASTIC CHAIN 1.5M - SHORT - LIME GREEN60.05.50452025-12-22
07908611212757ORTHOMETRIC ELASTIC CHAIN 1.5M - SHORT - EMERALD GREEN60.05.50432025-12-22
07908611212795ORTHOMETRIC ELASTIC CHAIN 1.5M - MEDIUM - TEAL GREEN60.05.60422025-12-22
07908611212856ORTHOMETRIC ELASTIC CHAIN 1.5M - MEDIUM - LIME GREEN60.05.60452025-12-22
07908611212863ORTHOMETRIC ELASTIC CHAIN 1.5M - LONG - LIME GREEN60.05.70452025-12-22
07908611212887ORTHOMETRIC ELASTIC CHAIN 1.5M - LONG - NEON YELLOW60.05.70462025-12-22
07908611212894ORTHOMETRIC ELASTIC CHAIN 4.5M - SHORT - ACQUA60.05.51412025-12-22

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00190746191794Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
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00190746191848Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191855Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191862Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191879Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
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00190746191893Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23