RIVA BOND 8800610

GUDID DO3688006101

SDI LIMITED

Glass ionomer dental cement

• Primary Device ID: DO3688006101
• NIH Device Record Key: 0dcd80b1-a7e4-461d-bcf4-0bee0688bcba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RIVA BOND
• Version Model Number: RIVA BOND LC P/L KT
• Catalog Number: 8800610
• 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: 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 4 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	DO3688006101 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062064

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 BOND]

• DO3688006121: RIVA BOND LC LQD REF
• DO3688006111: RIVA BOND LC PWD REF 5G
• DO3688006101: RIVA BOND LC P/L KT