PREORTHO Pre-Orthodontic Device

GUDID 04573443678816

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.

FOREST-ONE CO., LTD.

Orthodontic progressive aligner

• Primary Device ID: 04573443678816
• NIH Device Record Key: ed36db2c-cd32-47e8-9b48-301db334d39a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PREORTHO Pre-Orthodontic Device
• Version Model Number: T2-MH
• Company DUNS: 712750137
• Company Name: FOREST-ONE CO., LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04573443678816 [Primary]

FDA Product Code

• KMY: Positioner, Tooth, Preformed

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-23
• Device Publish Date: 2024-05-15

On-Brand Devices [PREORTHO Pre-Orthodontic Device]

• 04573443678847: An orthodontic appliance, typically supplied in series intended to be worn while sleeping and fo
• 04573443678830: An orthodontic appliance, typically supplied in series intended to be worn while sleeping and fo
• 04573443678823: An orthodontic appliance, typically supplied in series intended to be worn while sleeping and fo
• 04573443678816: An orthodontic appliance, typically supplied in series intended to be worn while sleeping and fo
• 04573443678809: An orthodontic appliance, typically supplied in series intended to be worn while sleeping and fo
• 04573443678793: An orthodontic appliance, typically supplied in series intended to be worn while sleeping and fo
• 04573443678786: An orthodontic appliance, typically supplied in series intended to be worn while sleeping and fo
• 04573443678779: An orthodontic appliance, typically supplied in series intended to be worn while sleeping and fo
• 04573443678762: An orthodontic appliance, typically supplied in series intended to be worn while sleeping and fo