FDA.reportPublic FDA data

FASTBRACES® Classic Clear UR2

Primary DI
00850048985308
Brand
FASTBRACES® Classic Clear UR2
Company
Orthoworld, L.L.C.
Model
Classic Clear UR2
Catalog number
99-U2-2R
Device description
Orthodontic Bracket
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
NJMBracket, Ceramic, Orthodontic

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130446000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130446000FASTBRACES CERAMIC BRACKETSOrthodontic Design and Production, Inc.2013-06-07NJM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850048985308PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850048985308008500489853088500489853080850048985308

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

Contacts#

Phone, Email table
PhoneEmail
9728679473info@fastbraces.com

Regulatory Flags#

DUNS number
047033213
Device count
1
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
00850048985070Fastbraces® Turbo™ Xtra Bracket KitTurbo XTRA Bracket Kit102K-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

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