| Primary Device ID | D746MTMLDAR11 |
| NIH Device Record Key | 0ad8dcfa-ab8b-4522-9bd0-89b9a8555752 |
| Commercial Distribution Discontinuation | 2021-02-19 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | MTML-Clear Aligner |
| Version Model Number | MTML-DAR1 |
| Catalog Number | MTML-DAR1 |
| 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 |
| Phone | +1(800)883-8733 |
| sales@essix.com | |
| Phone | +1(800)883-8733 |
| sales@essix.com | |
| Phone | +1(800)883-8733 |
| sales@essix.com | |
| Phone | +1(800)883-8733 |
| sales@essix.com | |
| Phone | +1(800)883-8733 |
| sales@essix.com | |
| Phone | +1(800)883-8733 |
| sales@essix.com | |
| Phone | +1(800)883-8733 |
| sales@essix.com | |
| Phone | +1(800)883-8733 |
| sales@essix.com | |
| Phone | +1(800)883-8733 |
| sales@essix.com | |
| Phone | +1(800)883-8733 |
| sales@essix.com | |
| Phone | +1(800)883-8733 |
| sales@essix.com | |
| Phone | +1(800)883-8733 |
| sales@essix.com | |
| Phone | +1(800)883-8733 |
| sales@essix.com | |
| Phone | +1(800)883-8733 |
| sales@essix.com | |
| Phone | +1(800)883-8733 |
| sales@essix.com | |
| Phone | +1(800)883-8733 |
| sales@essix.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D746MTMLDAR11 [Primary] |
| NXC | Aligner, sequential |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2021-02-22 |
| Device Publish Date | 2016-09-24 |
| 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 |