FDA.report

SLX® Clear Aligners

Primary DI
00190707072575
Brand
SLX® Clear Aligners
Company
ORTHO ORGANIZERS, INC.
Model
129-AL50
Device description
SLX® Clear Aligners
Published
2020-07-13
Public version status
New
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

Product Codes

CodeName
NXCAligner, sequential

Product Code Classifications

CodeDeviceSpecialtyClass
NXCAligner, SequentialDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190707072575PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190707072575001907070725751907070725750190707072575

GMDN Terms

TermDefinition
Orthodontic appliance system, progressiveA series of preformed teeth aligners or positioners, worn in succession and changed every few weeks, designed to influence the shape and/or function of the stomatognathic system; often used to impact a patient's appearance and self image. It is typically custom-made using computer-generated modelling based on an initial oral impression, and a consultation with an orthodontist. It is typically made of a clear hard plastic, e.g., a thermoformed polycarbonate (PC). It is typically used to correct malocclusions such as underbites, overbites, cross bites and open bites, or crooked teeth and various other flaws of teeth and jaws, whether cosmetic or structural. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
062165188
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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