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.

• 10190707115101 - TruFit™ 2.0: 2025-10-07 TruFit™ 2.0 ASM .018 ROTH UR6 CONV SBT -10T 10DOff 29.5 (3PK)
• 10190707115118 - TruFit™ 2.0: 2025-10-07 TruFit™ 2.0 ASM .018 ROTH UR6 CONV SBT -10T 10DOff 30.0 (3PK)
• 10190707115125 - TruFit™ 2.0: 2025-10-07 TruFit™ 2.0 ASM .018 ROTH UR6 CONV SBT -10T 10DOff 30.5 (3PK)
• 10190707115132 - TruFit™ 2.0: 2025-10-07 TruFit™ 2.0 ASM .018 ROTH UR6 CONV SBT -10T 10DOff 31.0 (3PK)
• 10190707115149 - TruFit™ 2.0: 2025-10-07 TruFit™ 2.0 ASM .018 ROTH UR6 CONV SBT -10T 10DOff 31.5 (3PK)
• 10190707115156 - TruFit™ 2.0: 2025-10-07 TruFit™ 2.0 ASM .018 ROTH UR6 CONV SBT -10T 10DOff 32.0 (3PK)
• 10190707115163 - TruFit™ 2.0: 2025-10-07 TruFit™ 2.0 ASM .018 ROTH UR6 CONV SBT -10T 10DOff 32.5 (3PK)
• 10190707115170 - TruFit™ 2.0: 2025-10-07 TruFit™ 2.0 ASM .018 ROTH UR6 CONV SBT -10T 10DOff 33.0 (3PK)