Trioclear System

GUDID 06972677870221

Modern Dental Laboratory (DG) Co., Ltd.

Orthodontic progressive aligner
Primary Device ID06972677870221
NIH Device Record Key4d1503dd-4e6a-4ca6-af3a-fa16f3c4fd88
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrioclear System
Version Model NumberS
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
GS106972677870221 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NXCAligner, Sequential

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-12
Device Publish Date2023-09-04

On-Brand Devices [Trioclear System]

06972677870139The TRIOCLEAR System is a removable, non-sterile device intended for single patient use. TRIOCLE
06972677870238H
06972677870221S
06972677870214S,H

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