Denture,restoration,orthodontic,anti-snoring,orthodontic

GUDID 06972677879996

Modern Dental Laboratory (DG) Co., Ltd.

Mandible-repositioning sleep-disordered breathing orthosis

Primary Device ID	06972677879996
NIH Device Record Key	fc36b3da-d932-4b45-9a2e-03da5730e912
Commercial Distribution Status	In Commercial Distribution
Brand Name	Denture,restoration,orthodontic,anti-snoring,orthodontic
Version Model Number	998
Company DUNS	551746187
Company Name	Modern Dental Laboratory (DG) Co., Ltd.
Device Count	11
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	true
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	06972677879989 [Primary]
GS1	06972677879996 [Unit of Use]

FDA Product Code

LRK	Device, Anti-Snoring

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

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[06972677879996]

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[06972677879996]

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[06972677879996]

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[06972677879996]

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Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2020-08-07
Device Publish Date	2020-07-30

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

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