LL-LED-II

GUDID 00817169021414

LUMINARY LED II CURING LIGHT

3D DENTAL DESIGNS AND DEVELOPMENT, LLC

Dental/surgical polymerization lamp

• Primary Device ID: 00817169021414
• NIH Device Record Key: d1821982-e045-42a9-9abd-fe0a86b82c45
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LL-LED-II
• Version Model Number: LL-LED-II
• 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	00817169021414 [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

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• 00817169023456 - 3D Green by 3D Dental: 2024-07-25 Bite Clock Covers Biodegradable (1000)
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• 00817169024668 - Essentials by 3D Dental: 2024-07-25 Headrest Cover Paper/Poly 10x10 White 500/Cs
• 00817169024675 - Essentials by 3D Dental: 2024-07-25 Headrest Cover Paper/Poly 10x13 White 500/Cs