AccessGUDID - DEVICE: ClearCorrect System Engager Template (D865REF06001)

GUDID

Device Identifier (DI) Information

Brand Name: ClearCorrect System Engager Template
Version or Model: REF06
Commercial Distribution Status: In Commercial Distribution
Catalog Number: REF06
Company Name: Clearcorrect Operating, LLC

Primary DI Number: D865REF06001
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 016449078 *Terms of Use

Device Description: Accessory device of the ClearCorrect System clear aligner system. Device is used by the clinician to add composite features to the teeth, referred to as Engagers. The Engagers have orthodontic force applied to them by the Aligners of the ClearCorrect System. The use of Engagers facilitates Aligner retention on the teeth and also facilities certain tooth movements that are difficult to achieve by applying force to the tooth surface itself. The Engager Template is used by the clinician in the clinical setting. The device is single use and disposed of after use. Duration of use is less than one hour.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
65436	Orthodontic resin positioning tray	A custom-made dental device in the form of a patient’s dentition which contains cavities intended to hold and facilitate positioning of light-cured dental resin onto teeth for subsequent attachment of an orthodontic appliance (e.g. aligner) after curing. It is typically made of synthetic polymer materials and is manufactured from an orthodontic treatment plan based on an oral cavity impression or oral scan for a specific patient. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QJJ	Indirect Bonding Tray

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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: 902061e5-4e12-4dd0-ba43-3c7d98dd393a
Public Version Date: February 12, 2024
Public Version Number: 1
DI Record Publish Date: February 02, 2024