SP NEWTRON LED 4K3.7V US EMB F55542

GUDID 03609820555423

Ultrasonic dental module

SATELEC

Ultrasonic dental scaling/debridement system

• Primary Device ID: 03609820555423
• NIH Device Record Key: 73c2d684-5756-4feb-bac8-592ebbf5cc76
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SP NEWTRON LED 4K3.7V US EMB
• Version Model Number: F55542
• Catalog Number: F55542
• Company DUNS: 381582196
• Company Name: SATELEC
• Device Count: 1
• DM Exempt: true
• 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: true
• 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 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	03609820555423 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033764

FDA Product Code

• ELC: Scaler, Ultrasonic

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: 2025-12-18
• Device Publish Date: 2025-12-10

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