Illuminate

GUDID 00190707041229

ILLUMINATE LIGHT-CURE ADHESIVE KIT

ORTHO ORGANIZERS, INC.

Orthodontic bracket adhesive

• Primary Device ID: 00190707041229
• NIH Device Record Key: b3e3c502-a713-4a27-a044-fd801dc5c959
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Illuminate
• Version Model Number: 471-050
• Company DUNS: 062165188
• Company Name: ORTHO ORGANIZERS, INC.
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 75 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190707041229 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K935625

FDA Product Code

• DYH: ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-08
• Device Publish Date: 2019-09-30

On-Brand Devices [Illuminate]

• 00190707041243: MINI ILLUMINATE LIGHT-CURE ADHESIVE KIT
• 00190707011109: ILLUMINATE LIGHT-CURE ADHESIVE
• 00190707010812: ILLUMINATE LIGHT-CURE ADHESIVE
• 00190707008239: ILLUMINATE LIGHT-CURE BONDING RESIN
• 00190707041236: ILLUMINATE LIGHT-CURE ADHESIVE
• 00190707041229: ILLUMINATE LIGHT-CURE ADHESIVE KIT