RIVA LC 8710002

GUDID DO3687100021

SDI LIMITED

Glass ionomer dental cement

• Primary Device ID: DO3687100021
• NIH Device Record Key: 44ea1c2a-358e-46d0-86aa-a8d14658b6b3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RIVA LC
• Version Model Number: RIVA LC STARTER KT A2
• Catalog Number: 8710002
• Company DUNS: 753221852
• Company Name: SDI LIMITED
• Device Count: 20
• 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: true
• 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	DO3687100020 [Unit of Use]
HIBCC	DO3687100021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050870

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: 2016-10-11

On-Brand Devices [RIVA LC]

• DO3687300061: RIVA LC HV B1 50 CAP
• DO3687300041: RIVA LC HV A3.5 50 CAP
• DO3687300031: RIVA LC HV A3 50 CAP
• DO3687300021: RIVA LC HV A2 50 CAP
• DO3687300011: RIVA LC HV A1 50 CAP
• DO3687100021: RIVA LC STARTER KT A2
• DO3687100011: RIVA LC STARTER KT A1
• DO3687100001: RIVA LC CAP ASSTD KT
• DO3687009001: RIVA LC LQD REF
• DO3687005121: RIVA LC C2 P/L KT
• DO3687005071: RIVA LC B2 P/L KT
• DO3687005051: RIVA LC A4 P/L KT
• DO3687005041: RIVA LC A3.5 P/L KT
• DO3687005031: RIVA LC A3 P/L KT
• DO3687005021: RIVA LC A2 P/L KT
• DO3687005011: RIVA LC A1 P/L KT
• DO3687001161: RIVA LC B PWD REF 15G
• DO3687001141: RIVA LC C4 PWD REF 15G
• DO3687001121: RIVA LC C2 PWD REF 15G
• DO3687001081: RIVA LC B3 PWD REF 15G
• DO3687001071: RIVA LC B2 PWD REF 15G
• DO3687001041: RIVA LC A3.5 PWD REF 15G
• DO3687001031: RIVA LC A3 PWD REF 15G
• DO3687001021: RIVA LC A2 PWD REF 15G
• DO3687001011: RIVA LC A1 PWD REF 15G
• DO3687000161: RIVA LC B 50 CAP
• DO3687000141: RIVA LC C4 50 CAP
• DO3687000121: RIVA LC C2 50 CAP
• DO3687000101: RIVA LC B4 50 CAP
• DO3687000081: RIVA LC B3 50 CAP
• DO3687000071: RIVA LC B2 50 CAP
• DO3687000051: RIVA LC A4 50 CAP
• DO3687000041: RIVA LC A3.5 50 CAP
• DO3687000031: RIVA LC A3 50 CAP
• DO3687000021: RIVA LC A2 50 CAP
• DO3687000011: RIVA LC A1 50 CAP