SHADE 7900000

GUDID DO3679000001

SDI LIMITED

Dental pit/fissure sealant

• Primary Device ID: DO3679000001
• NIH Device Record Key: dfe3689f-52c0-4983-a073-37a3ddcb3233
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SHADE
• Version Model Number: SHADE MODIFICATION KT
• Catalog Number: 7900000
• Company DUNS: 753221852
• Company Name: SDI LIMITED
• Device Count: 9
• DM Exempt: false
• 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: 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

Customer Support Contacts

• Phone: +18002285166
• Email: info@sdi.com.au

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 10 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	DO3679000000 [Unit of Use]
HIBCC	DO3679000001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K941899

FDA Product Code

• EBF: MATERIAL, TOOTH SHADE, RESIN

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: 2016-09-28

Devices Manufactured by SDI LIMITED

• DO3684520041 - LUNA 2: 2024-02-16
• DO3684520251 - LUNA 2: 2024-02-16
• DO3686400011 - STELA: 2024-02-16
• DO3686400021 - STELA: 2024-02-16
• DO3686400031 - STELA: 2024-02-16
• DO3686400041 - STELA: 2024-02-16
• DO3686400061 - STELA: 2024-02-16
• DO3685600011 - AURA: 2019-12-16