TRIOCLEAR System

GUDID 06972677870139

The TRIOCLEAR System is a removable, non-sterile device intended for single patient use. TRIOCLEAR is a series of clear plastic aligners that offer a solution for patients who want an aesthetic orthodontic treatment by utilizing sets of removable aligners to correct tooth malocclusions without the use of conventional wire and bracket orthodontic technology.

Modern Dental Laboratory (DG) Co., Ltd.

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• Primary Device ID: 06972677870139
• NIH Device Record Key: a4d8ef4d-31a1-45da-a181-d641c341ce5b
• Commercial Distribution Discontinuation: 2022-03-08
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: TRIOCLEAR System
• Version Model Number: 013
• Company DUNS: 551746187
• Company Name: Modern Dental Laboratory (DG) Co., Ltd.
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• 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
GS1	06972677870139 [Primary]

FDA Product Code

• NXC: Aligner, Sequential

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: 2022-03-16
• Device Publish Date: 2022-03-08

On-Brand Devices [TRIOCLEAR System]

• 06972677870139: The TRIOCLEAR System is a removable, non-sterile device intended for single patient use. TRIOCLE
• 06972677870238: H
• 06972677870221: S
• 06972677870214: S,H