PreXion3D

GUDID 04547497752334

Diagnostic imaging equipmente for dental treatment.three-dimensional(3D)

YOSHIDA DENTAL MFG. CO., LTD., THE

Limited-view-field CT system

• Primary Device ID: 04547497752334
• NIH Device Record Key: 8dd8a693-0cae-462f-8d6e-2111eff1e4e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PreXion3D
• Version Model Number: XP68UL
• Company DUNS: 690676978
• Company Name: YOSHIDA DENTAL MFG. CO., LTD., THE
• Device Count: 1
• DM Exempt: false
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +81336312165
• Email: yoshida4export-kokusai@yoshida-net.co.jp
• Phone: +81336312165
• Email: yoshida4export-kokusai@yoshida-net.co.jp
• Phone: +81336312165
• Email: yoshida4export-kokusai@yoshida-net.co.jp
• Phone: +81336312165
• Email: yoshida4export-kokusai@yoshida-net.co.jp
• Phone: +81336312165
• Email: yoshida4export-kokusai@yoshida-net.co.jp
• Phone: +81336312165
• Email: yoshida4export-kokusai@yoshida-net.co.jp
• Phone: +81336312165
• Email: yoshida4export-kokusai@yoshida-net.co.jp
• Phone: +81336312165
• Email: yoshida4export-kokusai@yoshida-net.co.jp
• Phone: +81336312165
• Email: yoshida4export-kokusai@yoshida-net.co.jp
• Phone: +81336312165
• Email: yoshida4export-kokusai@yoshida-net.co.jp
• Phone: +81336312165
• Email: yoshida4export-kokusai@yoshida-net.co.jp
• Phone: +81336312165
• Email: yoshida4export-kokusai@yoshida-net.co.jp
• Phone: +81336312165
• Email: yoshida4export-kokusai@yoshida-net.co.jp
• Phone: +81336312165
• Email: yoshida4export-kokusai@yoshida-net.co.jp
• Phone: +81336312165
• Email: yoshida4export-kokusai@yoshida-net.co.jp
• Phone: +81336312165
• Email: yoshida4export-kokusai@yoshida-net.co.jp

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04547497752334 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120948

FDA Product Code

• OAS: X-Ray, Tomography, Computed, Dental

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: 2024-07-25
• Device Publish Date: 2024-07-17

Devices Manufactured by YOSHIDA DENTAL MFG. CO., LTD., THE

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• 04547497759456 - Panoura X-ERA: 2019-05-20 Diagnostic imaging equipment for dental treatment. Panoramic imaging & three-dimensional(3D, FOV size x 4) image
• 04547497759463 - Panoura X-ERA: 2019-05-20 Diagnostic imaging equipment for dental treatment. Panoramic, Cephalometric imaging(1 sensor type) & three-dimensional(3D, FOV s
• 04547497759470 - Panoura X-ERA: 2019-05-20 Diagnostic imaging equipment for dental treatment. Panoramic, Cephalometric imaging(2 sensors type) & three-dimensional(3D, FOV
• 04547497759517 - Panoura X-ERA: 2019-05-20 Diagnostic imaging equipment for dental treatment. Panoramic imaging & three-dimensional(3D, FOV size x 2) image
• 04547497759524 - Panoura X-ERA: 2019-05-20 Diagnostic imaging equipment for dental treatment. Panoramic, Cephalometric imaging(1 sensor type) & three-dimensional(3D, FOV s
• 04547497759531 - Panoura X-ERA: 2019-05-20 Diagnostic imaging equipment for dental treatment. Panoramic, Cephalometric imaging(2 sensor type) & three-dimensional(3D, FOV s