Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009402818

FEI Number

3009402818

Entity Name

ORTHOWORLD, L.L.C.

City/State/Country

Red Oak, TX, US

Establishment Address

2670 FM 983, Red Oak, TX 75154, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Orthoworld, L.L.C. (Owner Number: 10038866)

Owner / Operator Contact Address

2670 FM 983, Red Oak, TX 75154, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Fastbraces® Combo Bracket Kit FASTBRACES® CLASSIC CLEAR LL/LR 1/2 FASTBRACES® CLASSIC CLEAR UL1 FASTBRACES® CLASSIC CLEAR UR1 FASTBRACES® CLASSIC CLEAR UL2 FASTBRACES® CLASSIC CLEAR LL3 FASTBRACES® CLASSIC CLEAR UR3 FASTBRACES® CLASSIC CLEAR UR2 FASTBRACES® CLASSIC CLEAR U/L 4/5 FASTBRACES® CLASSIC CLEAR LR3 FASTBRACES® CLASSIC CLEAR UL3 Fastbraces® Clear Bracket Kit Fastbraces® Combo-Turbo Bracket Kit FASTBRACES® TURBO® U/L 4/5 FASTBRACES® TURBO® LR3 FASTBRACES® TURBO® UL/LR 6 FASTBRACES® CLASSIC Metal LL/UR 6 FASTBRACES® CLASSIC Metal LL/LR 1/2 FASTBRACES® CLASSIC Metal U/L 4/5 FASTBRACES® TURBO® LL/UR 6 FASTBRACES® CLASSIC Metal UR2 FASTBRACES® TURBO® XTRA UR3 FASTBRACES® TURBO® XTRA UR1 Fastbraces® Turbo® XTRA Bracket Kit FASTBRACES® TURBO® XTRA UL3 FASTBRACES® TURBO® UR3 FASTBRACES® CLASSIC Metal UR1 FASTBRACES® TURBO® XTRA UL/LR 6 FASTBRACES® CLASSIC Metal LL3 FASTBRACES® TURBO® UR2 FASTBRACES® CLASSIC Metal UL1 FASTBRACES® TURBO® XTRA LL3 FASTBRACES® TURBO® XTRA UL1 FASTBRACES® TURBO® LL3 FASTBRACES® TURBO® LL/LR 1/2 FASTBRACES® TURBO® XTRA UL2 FASTBRACES® TURBO® XTRA LL/UR 6 Fastbraces® Turbo® Bracket Kit FASTBRACES® TURBO® XTRA LR3 FASTBRACES® TURBO® UL1 FASTBRACES® CLASSIC Metal UL3 FASTBRACES® TURBO® UL3 FASTBRACES® CLASSIC Metal LR3 Fastbraces® Metal Bracket Kit FASTBRACES® TURBO® XTRA LL/LR 1/2 FASTBRACES® CLASSIC Metal UL/LR 6 FASTBRACES® TURBO® UL2 FASTBRACES® CLASSIC Metal UR3 FASTBRACES® CLASSIC Metal UL2 FASTBRACES® TURBO® XTRA U/L 4/5 FASTBRACES® TURBO® UR1 FASTBRACES® TURBO® XTRA UR2 Fastbraces® Combo-Turbo Archwires Fastbraces® Ligature Wires (Clear, 3-pack) Fastbraces® Combo Archwires Fastbraces® Turbo® Archwires Fastbraces® Ligature Wires (Metal, 3-pack) Fastbraces® Turbo® Xtra Archwires Fastbraces® Retainer Fastbraces® Classic Metal Archwires Fastbraces® Aesthetic Archwires

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NJM	Bracket, Ceramic, Orthodontic	Dental	Class 2	872.5470	2014-11-19
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2011-11-17
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	2011-11-17

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Orthoworld, L.L.C.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K180404	3M Healthcare	3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System	2018-03-16
K894358	Ormco Corp.	LUMINA ORTHODONTIC BRACKET	1989-09-15
K925012	American Orthodontics	PLASTIC CHAIN	1993-09-13
K112640	Ormco Corp.	HYPERELASTIC WIRE	2011-11-16

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2024980	YOUNG INNOVATIONS INC.	Algonquin, IL, US
3027460334	LightForce Orthodontics	Wilmington, MA, US
3016543896	CSY INTERNATIONAL LLC	Rancho Cucamonga, CA, US
1000118628	FIVE STAR ORTHODONTIC LABORATORY & SUPPLY, INC.	Denton, TX, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009402818. Last updated year: 2026. Please use registration number 3009402818 when referencing this establishment in official correspondence.