LUNA 2 8452004

GUDID DO3684520041

SDI LIMITED

Dental composite resin

• Primary Device ID: DO3684520041
• NIH Device Record Key: 42a0eb70-4619-4f90-8da8-b58fc01e98c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LUNA 2
• Version Model Number: LUNA 2 1 SYR A3.5
• Catalog Number: 8452004
• Company DUNS: 753221852
• Company Name: SDI LIMITED
• 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: false
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	DO3684520041 [Primary]

FDA Product Code

• EBF: Material, Tooth Shade, 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: 2024-02-16
• Device Publish Date: 2024-02-08

On-Brand Devices [LUNA 2]

• DO3684520251: LUNA 2 INTRO KT
• DO3684520041: LUNA 2 1 SYR A3.5