AccessGUDID - DEVICE: Invisalign System with Mandibular advancement - enhanced precision wings (00816063022145)

GUDID

Device Identifier (DI) Information

Brand Name: Invisalign System with Mandibular advancement - enhanced precision wings
Version or Model: 222715
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Align Technology, Inc.

Primary DI Number: 00816063022145
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 013831768 *Terms of Use

Device Description: The Invisalign System with Mandibular advancement - enhanced precision wings (EPW) is used to treat patients with Class I and Class II malocclusion, severe open bit, severe overjet, deep bit, skeletally narrow jaw, and dental prostheses/implants, and/or those who require surgical correction. The EPW are modified precision wings with longer and curved wings, with an added rib on buccal side, which are designed to optimize mandibular advancement.

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 [?]
K181739	000
K220287	000

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: acda1cdd-23b3-4cea-af4f-0183461c2927
Public Version Date: August 01, 2023
Public Version Number: 1
DI Record Publish Date: July 24, 2023