PROMIX one 2770001000

GUDID J00927700010000

Dental mixer of Surefill one and Calibra Bio capsules, Brand Dentsply Sirona

Renfert GmbH

Dental amalgam mixer

• Primary Device ID: J00927700010000
• NIH Device Record Key: 2921d914-5088-422a-b00c-748cb7c92694
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PROMIX one
• Version Model Number: 2770001000
• Catalog Number: 2770001000
• Company DUNS: 328502976
• Company Name: Renfert GmbH
• 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: 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 Atmospheric Pressure: Between 70 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 96 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 96 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 96 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 96 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 96 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 96 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 96 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 96 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 96 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 96 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 96 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 96 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 96 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 96 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 96 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 96 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 96 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	J00927700010000 [Primary]

FDA Product Code

• EFD: Amalgamator, Dental, Ac-Powered

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: 2023-07-18
• Device Publish Date: 2023-07-10

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