Bite-Builder™

GUDID 10190707108288

Bite-Builder™ 10 per pack BITEBUILDER

ORTHO ORGANIZERS, INC.

Orthodontic bracket, plastic, single-use

• Primary Device ID: 10190707108288
• NIH Device Record Key: 0fe44393-7ec9-45cb-88ed-f8deabb6d9e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bite-Builder™
• Version Model Number: OT-2350
• Company DUNS: 062165188
• Company Name: ORTHO ORGANIZERS, INC.
• Device Count: 10
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190707108281 [Primary]
GS1	10190707108288 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K973776

FDA Product Code

• DYW: BRACKET, PLASTIC, 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: 2025-10-03
• Device Publish Date: 2025-09-25

Devices Manufactured by ORTHO ORGANIZERS, INC.

• 00190707075972 - Maestro® Band Assemblies: 2025-12-19 .022 Maestro® LR6 Std Buccal Tube Epic / Cleat (E)
• 00190707096755 - Reveal® Aligners: 2025-12-19 Reveal® Aligners
• 00190707096762 - Reveal® Aligners: 2025-12-19 Reveal® Aligners
• 00190707096779 - Reveal® Aligners: 2025-12-19 Reveal® Aligners
• 00190707096786 - Reveal® Aligners: 2025-12-19 Reveal® Aligners
• 00190707096793 - Reveal® Aligners: 2025-12-19 Reveal® Aligners
• 00190707096809 - Reveal® Aligners: 2025-12-19 Reveal® Aligners
• 00190707096816 - Reveal® Aligners: 2025-12-19 Reveal® Aligners