Unify

GUDID 00190707047818

UNIFY LIGHT CURE TRIAL KIT (SCREW) 3gms

ORTHO ORGANIZERS, INC.

Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive 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.

• 00190707183479 - Accufit: 2024-04-12 AccuFit Molar Band UR6 - 37
• 00190707183486 - Accufit: 2024-04-12 AccuFit Molar Band UL7 - 36.5
• 00190707183493 - Accufit: 2024-04-12 Accufit Molar Bands Lower Left First Molar 29 1/2
• 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