RIVA SILVER 8670008

GUDID DO3686700081

SDI LIMITED

Glass ionomer dental cement

• Primary Device ID: DO3686700081
• NIH Device Record Key: 4ff9ab61-3b32-4cec-b784-8f8c39ba1519
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RIVA SILVER
• Version Model Number: RIVA SILVER 50 CAP
• Catalog Number: 8670008
• 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: false
• 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	DO3686700080 [Unit of Use]
HIBCC	DO3686700081 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042452

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: 2016-10-07

On-Brand Devices [RIVA SILVER]

• DO3686709001: RIVA SILVER LQD REF 10G
• DO3686705081: RIVA SILVER P/L KT
• DO3686701081: RIVA SILVER PWD REF
• DO3686700081: RIVA SILVER 50 CAP