MTML-Clear Aligner MTML-DAR2

GUDID D746MTMLDAR21

MTML-Clear Aligner - Dual Arch Additional Refinement

RAINTREE ESSIX INC.

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Primary Device IDD746MTMLDAR21
NIH Device Record Keyb281c399-b4e1-43d6-a49b-7ddd8651d201
Commercial Distribution Discontinuation2021-02-19
Commercial Distribution StatusNot in Commercial Distribution
Brand NameMTML-Clear Aligner
Version Model NumberMTML-DAR2
Catalog NumberMTML-DAR2
Company DUNS801157132
Company NameRAINTREE ESSIX INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com
Phone+1(800)883-8733
Emailsales@essix.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD746MTMLDAR21 [Primary]

FDA Product Code

NXCAligner, sequential

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2021-02-22
Device Publish Date2016-09-24

On-Brand Devices [MTML-Clear Aligner]

D746MTMLRP1MTML-Clear Aligner Replacement Alignment
D746MTMLSAR21MTML-Clear Aligner - Single Arch Additional Refinement
D746MTMLSAR11MTML-Clear Aligner - Single Arch First Refinement
D746MTMLDAR21MTML-Clear Aligner - Dual Arch Additional Refinement
D746MTMLDAR11MTML-Clear Aligner - Dual Arch First Refinement
D746MTMLALSA1MTML-Clear Aligner-Single Arch
D746MTMLALDA21MTML-Clear Aligner-Dual Arch
D746MTMLALDA1MTML-Clear Aligner-Dual Arch
D746MTMALSA21MTML-Clear Aligner-Single Arch

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