FDA Registration Active 🇺🇸 United States

ORTHOWORLD, L.L.C.

Reg #: 3009402818 · FEI: 3009402818 · Expires 2026
Products
3
Proprietary Names
61
Establishment Types
1
Classifications
3

Registration Details

Registration Name
ORTHOWORLD, L.L.C.
Registration Number
3009402818
FEI Number
3009402818
Status
Active
Expiry Year
2026
Initial Importer
Yes
Address
2670 FM 983
City
Red Oak
State
TX
ZIP
75154
Country
US

Regulatory Submissions

510(k) Number
K130446

Owner / Operator

Firm Name
Orthoworld, L.L.C.
Operator Number
10038866
Address
2670 FM 983
City
Red Oak
State
TX
Postal Code
75154
Country
US

Products

Device Name Product Code
Bracket, Ceramic, Orthodontic NJM
Bracket, Metal, Orthodontic EJF
Wire, Orthodontic DZC

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

Establishment Types

Repack or Relabel Medical Device