FASTBRACES® Classic Clear UR3 99-U3-2RK

GUDID 00850048985315

Orthodontic Bracket

Orthoworld, L.L.C.

Orthodontic bracket, ceramic

• Primary Device ID: 00850048985315
• NIH Device Record Key: b2f93f36-a14b-4579-b8af-f945bfe61f65
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FASTBRACES® Classic Clear UR3
• Version Model Number: Classic Clear UR3
• Catalog Number: 99-U3-2RK
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 9728679473
• Email: info@fastbraces.com
• Phone: 9728679473
• Email: info@fastbraces.com
• Phone: 9728679473
• Email: info@fastbraces.com
• Phone: 9728679473
• Email: info@fastbraces.com
• Phone: 9728679473
• Email: info@fastbraces.com
• Phone: 9728679473
• Email: info@fastbraces.com
• Phone: 9728679473
• Email: info@fastbraces.com
• Phone: 9728679473
• Email: info@fastbraces.com
• Phone: 9728679473
• Email: info@fastbraces.com
• Phone: 9728679473
• Email: info@fastbraces.com
• Phone: 9728679473
• Email: info@fastbraces.com
• Phone: 9728679473
• Email: info@fastbraces.com
• Phone: 9728679473
• Email: info@fastbraces.com
• Phone: 9728679473
• Email: info@fastbraces.com
• Phone: 9728679473
• Email: info@fastbraces.com
• Phone: 9728679473
• Email: info@fastbraces.com
• Phone: 9728679473
• Email: info@fastbraces.com
• Phone: 9728679473
• Email: info@fastbraces.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850048985315 [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: 2024-05-22
• Device Publish Date: 2024-05-14

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