EZ-Align 0091

GUDID D84100911Z

Clear Sequential Aligner System

Dyna Flex of Missouri, L.P.

Orthodontic appliance system, progressive Orthodontic appliance system, progressive Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner

• 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