Orthodontic Appliance

GUDID 06972677870207

Modern Dental Laboratory (DG) Co., Ltd.

Orthodontic space maintainer
Primary Device ID06972677870207
NIH Device Record Key1b843c98-e5c0-441d-8ed8-563ce3d511fa
Commercial Distribution StatusIn Commercial Distribution
Brand NameOrthodontic Appliance
Version Model Number020
Company DUNS551746187
Company NameModern Dental Laboratory (DG) Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
GS106972677870207 [Primary]

FDA Product Code

DZCWire, Orthodontic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06972677870207]

Moist Heat or Steam Sterilization


[06972677870207]

Moist Heat or Steam Sterilization


[06972677870207]

Moist Heat or Steam Sterilization


[06972677870207]

Moist Heat or Steam Sterilization


[06972677870207]

Moist Heat or Steam Sterilization


[06972677870207]

Moist Heat or Steam Sterilization


[06972677870207]

Moist Heat or Steam Sterilization


[06972677870207]

Moist Heat or Steam Sterilization


[06972677870207]

Moist Heat or Steam Sterilization


[06972677870207]

Moist Heat or Steam Sterilization


[06972677870207]

Moist Heat or Steam Sterilization


[06972677870207]

Moist Heat or Steam Sterilization


[06972677870207]

Moist Heat or Steam Sterilization


[06972677870207]

Moist Heat or Steam Sterilization


[06972677870207]

Moist Heat or Steam Sterilization


[06972677870207]

Moist Heat or Steam Sterilization


[06972677870207]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-16
Device Publish Date2023-08-08

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
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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