Orthodontic retainer

GUDID 06972677870146

An orthodontic appliance, bonded or removable, intended to be used on a single patient to maintain teeth in corrected positions during the period of functional adaptation following corrective treatment. This appliance, also referred to as a positioner, is also used to maintain the positions of the teeth and jaws gained by orthodontic procedures.

Modern Dental Laboratory (DG) Co., Ltd.

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• Primary Device ID: 06972677870146
• NIH Device Record Key: 0295aeca-4ad2-4b4a-8028-a1cff070c6d8
• Commercial Distribution Discontinuation: 2022-03-09
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Orthodontic retainer
• Version Model Number: 014
• Company DUNS: 551746187
• Company Name: Modern Dental Laboratory (DG) Co., Ltd.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• 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	06972677870146 [Primary]

FDA Product Code

• DYT: Maintainer, Space Preformed, Orthodontic

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: 2022-03-17
• Device Publish Date: 2022-03-09

Devices Manufactured by Modern Dental Laboratory (DG) Co., Ltd.

• 06972677870214 - Trioclear System: 2023-09-12
• 06972677870221 - Trioclear System: 2023-09-12
• 06972677870238 - Trioclear System: 2023-09-12
• 06972677870207 - Orthodontic Appliance: 2023-08-16
• 06972677870191 - Respire Pink AT Series: 2022-09-27
• 06972677871877 - Respire Pink AT Series,Retainer: 2022-09-27
• 06972677871891 - Respire Pink AT Series,Splint: 2022-09-27
• 06972677870153 - Blue Series: 2022-09-05