Luminary-3D Dental

GUDID 00817169021391

LUMINARY LED CURING LIGHT

3D DENTAL DESIGNS AND DEVELOPMENT, LLC

Dental/surgical polymerization lamp

• Primary Device ID: 00817169021391
• NIH Device Record Key: bcdb88b1-0480-415a-a3f3-5f088305c68b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Luminary-3D Dental
• Version Model Number: LED
• Company DUNS: 080194935
• Company Name: 3D DENTAL DESIGNS AND DEVELOPMENT, LLC
• Device Count: 1
• DM Exempt: true
• 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: true
• Serial Number: false
• 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	00817169021391 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K001719

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: 2018-07-06
• Device Publish Date: 2017-01-18

On-Brand Devices [Luminary-3D Dental]

• 00817169021407: LUMINARY+ LED CURING LIGHT
• 00817169021391: LUMINARY LED CURING LIGHT
• 00817169022077: Luminary 3.0 Curing Light