Unify

GUDID 00190707047818

UNIFY LIGHT CURE TRIAL KIT (SCREW) 3gms

ORTHO ORGANIZERS, INC.

Orthodontic bracket adhesive

• Primary Device ID: 00190707047818
• NIH Device Record Key: ea747635-fb14-43df-aa08-18b1ef95bb95
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Unify
• Version Model Number: 506-0105TK3B
• Company DUNS: 062165188
• Company Name: ORTHO ORGANIZERS, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	00190707047818 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K831495

FDA Product Code

• DYH: ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN

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: 2019-10-10
• Device Publish Date: 2019-10-02

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)