AccessGUDID - DEVICE: MTML-Clear Aligner (D746MTMLALDA21)

GUDID

Device Identifier (DI) Information

Brand Name: MTML-Clear Aligner
Version or Model: MTML-AL-DA2
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: MTML-AL-DA2
Company Name: DENTSPLY SIRONA ORTHODONTICS INC.

Primary DI Number: D746MTMLALDA21
Issuing Agency: HIBCC
Commercial Distribution End Date: February 19, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 116903307 *Terms of Use

Device Description: MTML-Clear Aligner-Dual Arch

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":	Yes
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?
44728	Dental shaded pontic kit	A collection of devices intended to be used to produce artificial tooth veneers (shaded pontics) typically inside clear plastic custom-made teeth aligners (retainer-style orthodontic appliances). This is used to create the appearance of teeth inside the aligner to cover spaces where teeth may be missing for aesthetic purposes during treatment to realign teeth. The contents of the device may include polymer-based materials, dispenser gun, mixing tips, applicator brushes and practice aligner.	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: 70604b79-47e6-4b45-aed9-3362864e2684
Public Version Date: February 29, 2024
Public Version Number: 4
DI Record Publish Date: September 24, 2016