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.

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• 00190707183509 - Accufit: 2024-04-12 Accufit Molar Bands Lower Left First Molar 30
• 00190707183516 - Accufit: 2024-04-12 Accufit Molar Bands Lower Left First Molar 30 1/2
• 00190707183523 - Accufit: 2024-04-12 Accufit Molar Bands Lower Left First Molar 31
• 00190707183530 - Accufit: 2024-04-12 Accufit Molar Bands Lower Left First Molar 31 1/2
• 00190707183547 - Accufit: 2024-04-12 Accufit Molar Bands Lower Left First Molar 32