RIVA 8800000

GUDID DO3688000001

SDI LIMITED

Glass ionomer dental cement

• Primary Device ID: DO3688000001
• NIH Device Record Key: c6799539-21d0-4abd-be24-287ac7b9f7ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RIVA
• Version Model Number: RIVA ASSORTED GIC KT
• Catalog Number: 8800000
• Company DUNS: 753221852
• Company Name: SDI LIMITED
• Device Count: 50
• 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: true
• 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 5 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	DO3688000000 [Unit of Use]
HIBCC	DO3688000001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030516

FDA Product Code

• EMA: CEMENT, DENTAL

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: 2016-10-10

On-Brand Devices [RIVA]

• DO3688001001: RIVA ASSORTED GIC FAST SET KT
• DO3688000001: RIVA ASSORTED GIC KT