MTML-Clear Aligner MTML-AL-SA2

GUDID D746MTMALSA21

MTML-Clear Aligner-Single Arch

RAINTREE ESSIX INC.

Dental shaded pontic kit Dental shaded pontic kit Dental shaded pontic kit Dental shaded pontic kit Dental shaded pontic kit Dental shaded pontic kit Dental shaded pontic kit Dental shaded pontic kit Dental shaded pontic kit Dental shaded pontic kit Dental shaded pontic kit Dental shaded pontic kit Dental shaded pontic kit Dental shaded pontic kit Dental shaded pontic kit Dental shaded pontic kit

• Primary Device ID: D746MTMALSA21
• NIH Device Record Key: d2d415e1-c87f-4e6b-a5c6-3d3533467fc8
• Commercial Distribution Discontinuation: 2021-02-19
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: MTML-Clear Aligner
• Version Model Number: MTML-AL-SA2
• Catalog Number: MTML-AL-SA2
• Company DUNS: 801157132
• Company Name: RAINTREE ESSIX INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D746MTMALSA21 [Primary]

FDA Product Code

• NXC: Aligner, sequential

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2021-02-22
• Device Publish Date: 2016-09-24

On-Brand Devices [MTML-Clear Aligner]

• D746MTMLRP1: MTML-Clear Aligner Replacement Alignment
• D746MTMLSAR21: MTML-Clear Aligner - Single Arch Additional Refinement
• D746MTMLSAR11: MTML-Clear Aligner - Single Arch First Refinement
• D746MTMLDAR21: MTML-Clear Aligner - Dual Arch Additional Refinement
• D746MTMLDAR11: MTML-Clear Aligner - Dual Arch First Refinement
• D746MTMLALSA1: MTML-Clear Aligner-Single Arch
• D746MTMLALDA21: MTML-Clear Aligner-Dual Arch
• D746MTMLALDA1: MTML-Clear Aligner-Dual Arch
• D746MTMALSA21: MTML-Clear Aligner-Single Arch