RIVA LUTING 8650008

GUDID DO3686500081

SDI LIMITED

Glass ionomer dental cement

• Primary Device ID: DO3686500081
• NIH Device Record Key: 83aadfd1-3edf-46ed-8d6e-8cecf7685dfd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RIVA LUTING
• Version Model Number: RIVA LUTING LY 50 CAP
• Catalog Number: 8650008
• 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	DO3686500080 [Unit of Use]
HIBCC	DO3686500081 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040393

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 LUTING]

• DO3686519001: RIVA LUTING PLUS LQD REF 10G
• DO3686515081: RIVA LUTING PLUS P/L KT
• DO3686511081: RIVA LUTING PLUS PWD REF 25G
• DO3686510081: RIVA LUTING PLUS 50 CAP
• DO3686509001: RIVA LUTING LQD REF 25G
• DO3686505101: RIVA LUTING P/L TRIPLE PK
• DO3686505081: RIVA LUTING P/L KT LARGE
• DO3686501081: RIVA LUTING LY PWD REF 35
• DO3686500081: RIVA LUTING LY 50 CAP