FDA.reportPublic FDA data

Fastbraces® Turbo™ Xtra Bracket Kit

Primary DI
00850048985070
Brand
Fastbraces® Turbo™ Xtra Bracket Kit
Company
Orthoworld, L.L.C.
Model
Turbo XTRA Bracket Kit
Catalog number
102K-345-22-01
Device description
Orthodontic Bracket Kit
Published
2024-05-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
00850048985070PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850048985070008500489850708500489850700850048985070

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic bracket, metalA metallic device that is bonded to an orthodontic band, or directly to a tooth, to hold an orthodontic wire and/or other appliance (e.g., rubber bands) used to apply pressure to the tooth in order to alter the position of the tooth. 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

Contacts#

Phone, Email table
PhoneEmail
972-867-9473info@fastbraces.com

Regulatory Flags#

DUNS number
047033213
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850048985025Fastbraces® CLASSIC Metal Bracket KitMetal Bracket Kit98K-345-22-012024-05-14
00850048985032Fastbraces® CLASSIC COMBO™ Bracket KitCombo Bracket Kit97K-345-22-012024-05-14
00850048985049Fastbraces® CLASSIC Clear Bracket KitClear Bracket Kit99K-345-22-012024-05-14
00850048985056Fastbraces® TURBO™ Bracket KitTurbo Bracket Kit100K-345-22-012024-05-14
00850048985063Fastbraces® COMBO TURBO™ Bracket KitCombo Turbo Bracket Kit101K-345-22-012024-05-14
00850048985087Fastbraces® Turbo® Xtra ArchwiresTurbo XTRA ArchwiresW83U-2020-04TX2024-05-14
00850048985094Fastbraces® Turbo® ArchwiresTurbo Archwires W83U-2020-04T2024-05-14
00850048985100Fastbraces® COMBO Turbo® ArchwiresCombo Turbo Archwires W83U-2020-04CT2024-05-14
00850048985117Fastbraces® Classic Metal ArchwiresMetal ArchwiresW83U-2020-042024-05-14
00850048985124Fastbraces® Classic Clear Archwires Clear ArchwiresW83U-2020-04C2024-05-14
00850048985131Fastbraces® Classic Combo Archwires Combo ArchwiresW83U-2020-04M2024-05-14
00850048985148FASTBRACES® Classic Metal UL1 Classic Metal UL1 98-U1-2L2024-05-14
00850048985155FASTBRACES® Classic Metal UL2 Classic Metal UL2 98-U2-2L2024-05-14
00850048985162FASTBRACES® Classic Metal UL3 Classic Metal UL3 98-U3-2LK2024-05-14
00850048985179FASTBRACES® Classic Metal UR1 Classic Metal UR1 98-U1-2R2024-05-14
00850048985186FASTBRACES® Classic Metal UR2 Classic Metal UR298-U2-2R2024-05-14
00850048985193FASTBRACES® Classic Metal UR3 Classic Metal UR398-U3-2RK2024-05-14
00850048985209FASTBRACES® Classic Metal U/L 4/5 Classic Metal U/L 4/598-U4-2UK2024-05-14
00850048985216FASTBRACES® Classic Metal LL/LR 1/2 Classic Metal LL/LR 1/298-L1-2U2024-05-14
00850048985223FASTBRACES® Classic Metal LL3 Classic Metal LL398-L3-2LK2024-05-14

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