Trioclear System

GUDID 06972677870214

Modern Dental Laboratory (DG) Co., Ltd.

Orthodontic progressive aligner

• Primary Device ID: 06972677870214
• NIH Device Record Key: 12b58ddc-867c-4ef0-b62b-548499daec21
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trioclear System
• Version Model Number: S,H
• Company DUNS: 551746187
• Company Name: Modern Dental Laboratory (DG) Co., Ltd.
• Device Count: 1
• DM Exempt: false
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06972677870214 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231884

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: 2023-09-12
• Device Publish Date: 2023-09-04

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