AccessGUDID - DEVICE: TRIOCLEAR System (06972677870139)

GUDID

Device Identifier (DI) Information

Brand Name: TRIOCLEAR System
Version or Model: 013
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Modern Dental Laboratory (DG) Co., Ltd.

Primary DI Number: 06972677870139
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 551746187 *Terms of Use

Device Description: The TRIOCLEAR System is a removable, non-sterile device intended for single patient use. TRIOCLEAR is a series of clear plastic aligners that offer a solution for patients who want an aesthetic orthodontic treatment by utilizing sets of removable aligners to correct tooth malocclusions without the use of conventional wire and bracket orthodontic technology.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
44738	Orthodontic progressive aligner	A custom-made orthodontic appliance, typically supplied in series intended to be worn in succession and self-changed every few weeks, designed to influence the shape and/or function of the stomatognathic system to correct malocclusions (e.g., underbites, overbites, cross bites, open bites, crooked teeth) and/or other cosmetic and/or structural flaws of teeth and/or jaws. Also described as sequential or successive, the device is custom-made based on an oral impression, self-removable, and is typically made of clear/transparent synthetic polymers (e.g., a thermoformed polycarbonate); a post-treatment orthodontic retainer/positioner may be included with the device. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NXC	Aligner, Sequential

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a4d8ef4d-31a1-45da-a181-d641c341ce5b
Public Version Date: May 19, 2023
Public Version Number: 2
DI Record Publish Date: March 08, 2022