SmartLite Focus 64450040

GUDID D010644500400

SmartLite Focus Eye Protection Sields are a part of the SmartLite Focus Curing Light and are available separately.

Dentsply De Trey GmbH

Dental/surgical polymerization lamp

• Primary Device ID: D010644500400
• NIH Device Record Key: 062bfd0e-d0a9-49b7-ab25-173f45069532
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SmartLite Focus
• Version Model Number: 64450040
• Catalog Number: 64450040
• Company DUNS: 315471722
• Company Name: Dentsply De Trey GmbH
• Device Count: 5
• DM Exempt: true
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Outer Diameter: 2 Centimeter
• Outer Diameter: 2 Centimeter
• Outer Diameter: 2 Centimeter
• Outer Diameter: 2 Centimeter
• Outer Diameter: 2 Centimeter
• Outer Diameter: 2 Centimeter
• Outer Diameter: 2 Centimeter
• Outer Diameter: 2 Centimeter
• Outer Diameter: 2 Centimeter
• Outer Diameter: 2 Centimeter
• Outer Diameter: 2 Centimeter
• Outer Diameter: 2 Centimeter
• Outer Diameter: 2 Centimeter
• Outer Diameter: 2 Centimeter
• Outer Diameter: 2 Centimeter
• Outer Diameter: 2 Centimeter
• Outer Diameter: 2 Centimeter
• Outer Diameter: 2 Centimeter
• Outer Diameter: 2 Centimeter
• Outer Diameter: 2 Centimeter
• Outer Diameter: 2 Centimeter
• Outer Diameter: 2 Centimeter
• Outer Diameter: 2 Centimeter
• Outer Diameter: 2 Centimeter
• Outer Diameter: 2 Centimeter
• Outer Diameter: 2 Centimeter
• Outer Diameter: 2 Centimeter
• Outer Diameter: 2 Centimeter
• Outer Diameter: 2 Centimeter
• Outer Diameter: 2 Centimeter
• Outer Diameter: 2 Centimeter
• Outer Diameter: 2 Centimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D010644500400 [Unit of Use]
HIBCC	D010644500401 [Primary]

FDA Product Code

• EBZ: ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION

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: 2020-12-24
• Device Publish Date: 2020-12-16

On-Brand Devices [SmartLite Focus]

• D010644500701: SmartLite Focus Charging Base is a part of the SmartLite Focus Curing Light and is available sep
• D010644500501: SmartLite Focus Power Connector is a part of the SmartLite Focus Curing Light and is available s
• D010644500400: SmartLite Focus Eye Protection Sields are a part of the SmartLite Focus Curing Light and are ava
• D010644500211: SmartLite Focus Battery Pack is a part of the SmartLite Focus Curing Light and is available sepa
• D010644500601: SmartLite Focus Refill is a cordless pen-style, LED light polymerization device for use by train
• D010644500201: SmartLite Focus Intro Package is a cordless pen-style, LED light polymerization device for use b