Clear Blue

GUDID 00862314000301

LED curing light

JOHNSON-PROMIDENT

Dental laboratory curing unit Dental laboratory curing unit Dental laboratory curing unit Dental laboratory curing unit Dental laboratory curing unit Dental laboratory curing unit Dental laboratory curing unit Dental laboratory curing unit Dental laboratory curing unit Dental laboratory curing unit Dental laboratory curing unit Dental laboratory curing unit Dental laboratory curing unit Dental laboratory curing unit Dental laboratory curing unit Dental laboratory curing unit 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