EZ-Align 0091

GUDID D84100911Z

Clear Sequential Aligner System

Dyna Flex of Missouri, L.P.

Orthodontic appliance system, progressive

• Primary Device ID: D84100911Z
• NIH Device Record Key: c1a2bc0c-d07b-4744-8d40-4d7cdb7e1c4d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EZ-Align
• Version Model Number: 0091
• Catalog Number: 0091
• Company DUNS: 006335558
• Company Name: Dyna Flex of Missouri, L.P.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• 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
HIBCC	D84100911Z [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121396

FDA Product Code

• NXC: Aligner, Sequential

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-02-10

On-Brand Devices [EZ-Align]

• D8410091U1M: Orthodontic Plastic Bracket (Sequential Aligners). Upper Tray
• D8410091L1D: Sequential Aligner (Lower Tray)
• D84100911Z: Clear Sequential Aligner System