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.

Orthodontic retainer
Primary Device ID06972677870146
NIH Device Record Key0295aeca-4ad2-4b4a-8028-a1cff070c6d8
Commercial Distribution Discontinuation2022-03-09
Commercial Distribution StatusNot in Commercial Distribution
Brand NameOrthodontic retainer
Version Model Number014
Company DUNS551746187
Company NameModern Dental Laboratory (DG) Co., Ltd.
Device Count1
DM Exempttrue
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
GS106972677870146 [Primary]

FDA Product Code

DYTMaintainer, Space Preformed, Orthodontic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-03-17
Device Publish Date2022-03-09

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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