FDA.reportPublic FDA data

PREORTHO Pre-Orthodontic Device

Primary DI
04573443678809
Brand
PREORTHO Pre-Orthodontic Device
Company
FOREST-ONE CO., LTD.
Model
T1-SS
Device description
An orthodontic appliance, typically supplied in series intended to be worn while sleeping and for about one hour during the day, 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 structural flaws of teeth and or jaws. The device is self-removable, a post-treatment orthodontic retainer positioner may be included with the device. This is a reusable device.
Published
2024-05-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KMYPositioner, Tooth, Preformed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMYPositioner, Tooth, PreformedDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04573443678809PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04573443678809045734436788094573443678809

GMDN Terms#

Term, Definition table
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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
712750137
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04573443678762PREORTHO Pre-Orthodontic DeviceT1-LH2024-05-15
04573443678779PREORTHO Pre-Orthodontic DeviceT1-MH2024-05-15
04573443678786PREORTHO Pre-Orthodontic DeviceT1-MS2024-05-15
04573443678793PREORTHO Pre-Orthodontic DeviceT1-SH2024-05-15
04573443678816PREORTHO Pre-Orthodontic DeviceT2-MH2024-05-15
04573443678823PREORTHO Pre-Orthodontic DeviceT3-MH2024-05-15
04573443678830PREORTHO Pre-Orthodontic DeviceT3-SH2024-05-15
04573443678847PREORTHO Pre-Orthodontic DeviceT3-SS2024-05-15

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08719425509556NextDentVertex-Dental B.V.KMY2023-06-15
H66842000111KeyPrintKeystone IndustriesKMY2023-02-20
H66842001611KeyPrintKeystone IndustriesKMY2023-02-20
H66842200111KeyPrintKeystone IndustriesKMY2023-02-20
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