RIVA PROTECT 8680000

GUDID DO3686800001

SDI LIMITED

Glass ionomer dental cement

• Primary Device ID: DO3686800001
• NIH Device Record Key: 977c4ef6-e5ac-4881-8364-50974f4679aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RIVA PROTECT
• Version Model Number: RIVA PROTECT PINK 50 CAP
• Catalog Number: 8680000
• 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	DO3686800000 [Unit of Use]
HIBCC	DO3686800001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050871

FDA Product Code

• EBC: SEALANT, PIT AND FISSURE, AND CONDITIONER

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 PROTECT]

• DO3686950001: RIVA PROTECT WHT 50 CAP FAST
• DO3686905011: RIVA PROTECT P/L WHITE
• DO3686901011: RIVA PROTECT PWD REF WHITE
• DO3686900001: RIVA PROTECT WHITE 50 CAP
• DO3686850001: RIVA PROTECT PINK 50 CAP FAST
• DO3686809001: RIVA PROTECT LQD REF
• DO3686805011: RIVA PROTECT P/L PINK
• DO3686801011: RIVA PROTECT PWD REF PINK
• DO3686800001: RIVA PROTECT PINK 50 CAP