SMARTLITE FOCUS 64450020

GUDID D010644500201

SmartLite Focus Intro Package is a cordless pen-style, LED light polymerization device for use by trained dental professionals or dental laboratories. SmartLite Focus is received as a handpiece together with a battery pack. With its supporting accessories (Charging Base, Shields, SmartLite Sleeves, Power Connector) it can be classified as convenience kit.

Dentsply De Trey GmbH

Dental/surgical polymerization lamp

• Primary Device ID: D010644500201
• NIH Device Record Key: 6b8f8e50-90d8-4507-b6e5-260baf5068c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SMARTLITE FOCUS
• Version Model Number: 64450020
• Catalog Number: 64450020
• Company DUNS: 315471722
• Company Name: Dentsply De Trey GmbH
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D010644500201 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2021-10-20
• Device Publish Date: 2017-03-16

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