LUNE™ PureHygiene

GUDID 00860013727000

Console

ENAMEL PURE INC

Dental photo-activated disinfection system

• Primary Device ID: 00860013727000
• NIH Device Record Key: 1ead822c-2500-4d1a-bc6f-b54e52126eb4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LUNE™ PureHygiene
• Version Model Number: EN0000-110-00
• Company DUNS: 117461944
• Company Name: ENAMEL PURE INC
• 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: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860013727000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K234085

FDA Product Code

• GEX: Powered Laser Surgical Instrument

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: 2025-04-22
• Device Publish Date: 2025-04-14