Fastbraces

GUDID 00860006117306

Orthoworld, L.L.C.

Orthodontic bracket, ceramic

• Primary Device ID: 00860006117306
• NIH Device Record Key: c2c3ea74-b73e-4e6c-92df-acf41a5702cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fastbraces
• Version Model Number: Clear Ceramic Brackets
• Company DUNS: 047033213
• Company Name: Orthoworld, L.L.C.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860006117306 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130446

FDA Product Code

• NJM: Bracket, Ceramic, Orthodontic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-02-01
• Device Publish Date: 2021-01-22

Devices Manufactured by Orthoworld, L.L.C.

• 00850048985025 - Fastbraces® CLASSIC Metal Bracket Kit: 2024-05-22 Orthodontic Bracket Kit
• 00850048985032 - Fastbraces® CLASSIC COMBO™ Bracket Kit: 2024-05-22 Orthodontic Bracket Kit
• 00850048985049 - Fastbraces® CLASSIC Clear Bracket Kit: 2024-05-22 Orthodontic Bracket Kit
• 00850048985056 - Fastbraces® TURBO™ Bracket Kit: 2024-05-22 Orthodontic Bracket Kit
• 00850048985063 - Fastbraces® COMBO TURBO™ Bracket Kit: 2024-05-22 Orthodontic Bracket Kit
• 00850048985070 - Fastbraces® Turbo™ Xtra Bracket Kit: 2024-05-22 Orthodontic Bracket Kit
• 00850048985087 - Fastbraces® Turbo® Xtra Archwires: 2024-05-22 Orthodontic Archwire
• 00850048985094 - Fastbraces® Turbo® Archwires: 2024-05-22 Orthodontic Archwire