LED CURING LIGHT

GUDID 04719873120819

BONART CO., LTD.

Dental laboratory curing unit

• Primary Device ID: 04719873120819
• NIH Device Record Key: a4c99e44-1c27-4ece-9e48-bf1fcb1bcf40
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LED CURING LIGHT
• Version Model Number: ART-L3 PRO
• Company DUNS: 657263687
• Company Name: BONART CO., LTD.
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719873120819 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062289

FDA Product Code

• EBZ: Activator, Ultraviolet, For Polymerization

Sterilization

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

[04719873120819]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-01-19

On-Brand Devices [LED CURING LIGHT]

• 04719873120819: ART-L3 PRO
• 04719873120802: ART-L3