Clear Blue

GUDID 00862314000301

LED curing light

JOHNSON-PROMIDENT

Dental laboratory curing unit

• Primary Device ID: 00862314000301
• NIH Device Record Key: 7f03ffe5-8942-4efa-9947-6968213dd05f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Clear Blue
• Version Model Number: Digi 2.0
• Company DUNS: 965230188
• Company Name: JOHNSON-PROMIDENT
• 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: false
• Serial Number: true
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00862314000301 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172426

FDA Product Code

• EBZ: Activator, Ultraviolet, For Polymerization

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00862314000301]

Moist Heat or Steam Sterilization

[00862314000301]

Moist Heat or Steam Sterilization

[00862314000301]

Moist Heat or Steam Sterilization

[00862314000301]

Moist Heat or Steam Sterilization

[00862314000301]

Moist Heat or Steam Sterilization

[00862314000301]

Moist Heat or Steam Sterilization

[00862314000301]

Moist Heat or Steam Sterilization

[00862314000301]

Moist Heat or Steam Sterilization

[00862314000301]

Moist Heat or Steam Sterilization

[00862314000301]

Moist Heat or Steam Sterilization

[00862314000301]

Moist Heat or Steam Sterilization

[00862314000301]

Moist Heat or Steam Sterilization

[00862314000301]

Moist Heat or Steam Sterilization

[00862314000301]

Moist Heat or Steam Sterilization

[00862314000301]

Moist Heat or Steam Sterilization

[00862314000301]

Moist Heat or Steam Sterilization

[00862314000301]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-08-24

Devices Manufactured by JOHNSON-PROMIDENT

• 00862314000301 - Clear Blue: 2018-03-29LED curing light
• 00862314000301 - Clear Blue: 2018-03-29 LED curing light
• 00862314000318 - Johnson-Promident: 2018-03-29 ultrasonic scaling insert
• 00862314000325 - Johnson-Promident: 2018-03-29 ultrasonic scaling insert
• 00862314000332 - Johnson-Promident: 2018-03-29 ultrasonic scaling insert
• 00862314000349 - Johnson-Promident: 2018-03-29 ultrasonic scaling insert
• 00862314000356 - Johnson-Promident: 2018-03-29 ultrasonic scaling insert
• 00862314000363 - Johnson-Promident: 2018-03-29 ultrasonic scaling insert
• 00862314000370 - Johnson-Promident: 2018-03-29 ultrasonic scaling insert