AccessGUDID - DEVICE: ClearCorrect System (D865REF00011)

GUDID

Device Identifier (DI) Information

Brand Name: ClearCorrect System
Version or Model: Aligner (Single-Layer)
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: REF-01
Company Name: Clearcorrect Operating, LLC

Primary DI Number: D865REF00011
Issuing Agency: HIBCC
Commercial Distribution End Date: August 25, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 016449078 *Terms of Use

Device Description: The ClearCorrect device is fabricated of clear thin thermoformed polyeurethane plastic in a sequential series to progressively reposition teeth. Corrective force to straighten teeth is delivered via minor changes into a position in each subsequent aligner.

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:	Yes
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: 4a26cd54-a597-4e89-b35b-23b79fb05372
Public Version Date: August 28, 2023
Public Version Number: 4
DI Record Publish Date: July 23, 2020