FDA.report

MTM® Clear Aligner

Primary DI
D746MTMALSA1001
Brand
MTM® Clear Aligner
Company
RAINTREE ESSIX INC.
Model
MTMALSA100
Catalog number
MTMALSA100
Device description
MTM® Clear Aligner Single Arch - Free
Published
2018-02-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
NXCAligner, sequential

Product Code Classifications

CodeDeviceSpecialtyClass
NXCAligner, SequentialDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D746MTMALSA1001PrimaryHIBCC0

GMDN Terms

TermDefinition
Orthodontic progressive alignerA 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.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)883-8733sales@essix.com

Regulatory Flags

DUNS number
801157132
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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