Pink Series

GUDID 06972677870160

Modern Dental Laboratory (DG) Co., Ltd.

Mandible-repositioning sleep-disordered breathing orthosis
Primary Device ID06972677870160
NIH Device Record Key14c8f5f6-aaaa-42c1-b500-70406c7a1631
Commercial Distribution StatusIn Commercial Distribution
Brand NamePink Series
Version Model Number016
Company DUNS551746187
Company NameModern Dental Laboratory (DG) Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106972677870160 [Primary]

FDA Product Code

LRKDevice, Anti-Snoring

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06972677870160]

Moist Heat or Steam Sterilization


[06972677870160]

Moist Heat or Steam Sterilization


[06972677870160]

Moist Heat or Steam Sterilization


[06972677870160]

Moist Heat or Steam Sterilization


[06972677870160]

Moist Heat or Steam Sterilization


[06972677870160]

Moist Heat or Steam Sterilization


[06972677870160]

Moist Heat or Steam Sterilization


[06972677870160]

Moist Heat or Steam Sterilization


[06972677870160]

Moist Heat or Steam Sterilization


[06972677870160]

Moist Heat or Steam Sterilization


[06972677870160]

Moist Heat or Steam Sterilization


[06972677870160]

Moist Heat or Steam Sterilization


[06972677870160]

Moist Heat or Steam Sterilization


[06972677870160]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-09-05
Device Publish Date2022-08-26

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

06972677870214 - Trioclear System 2023-09-12
06972677870221 - Trioclear System2023-09-12
06972677870238 - Trioclear System2023-09-12
06972677870207 - Orthodontic Appliance2023-08-16
06972677870191 - Respire Pink AT Series2022-09-27
06972677871877 - Respire Pink AT Series,Retainer2022-09-27
06972677871891 - Respire Pink AT Series,Splint2022-09-27
06972677870153 - Blue Series2022-09-05

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