Dental Chair 41000008156

GUDID 07899581340925

CADEIRA SYNCRUS G2 P1

Alliage S/A Indústrias Médico Odontológica

Dental chair, electric

• Primary Device ID: 07899581340925
• NIH Device Record Key: 9bf33550-325b-4fed-87c2-cdc913db16b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dental Chair
• Version Model Number: Syncrus G2
• Catalog Number: 41000008156
• Company DUNS: 898231451
• Company Name: Alliage S/A Indústrias Médico Odontológica
• 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: true
• Serial Number: true
• Manufacturing Date: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -12 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -12 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -12 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -12 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -12 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -12 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -12 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -12 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -12 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -12 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -12 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -12 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -12 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -12 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	07899581340925 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K863016

FDA Product Code

• KLC: Chair, Dental, With Operative Unit

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: 2025-08-04
• Device Publish Date: 2025-07-25

Devices Manufactured by Alliage S/A Indústrias Médico Odontológica

• 07899581340925 - Dental Chair: 2025-08-04CADEIRA SYNCRUS G2 P1
• 07899581340925 - Dental Chair: 2025-08-04 CADEIRA SYNCRUS G2 P1
• 07899581337437 - EAGLE X-RAY: 2024-03-05
• 07899581340703 - EAGLE X-RAY: 2024-03-05
• 07899581340642 - Dental CT Scanner AXR: 2024-03-04 Tomography only (SFOV)
• 07899581340659 - Dental CT Scanner AXR: 2024-03-04 Tomography with Cephalostat (MFOV)
• 07899581340734 - SXR / Saevo: 2024-03-04 Panoramic with Cephalostat (2 sensors)
• 07899581340741 - SXR / Saevo: 2024-03-04 Tomography with Cephalostat (SFOV)
• 07899581340758 - SXR / Saevo: 2024-03-04 Panoramic Only