RIVA SC 8600004

GUDID DO3686000041

SDI LIMITED

Glass ionomer dental cement

• Primary Device ID: DO3686000041
• NIH Device Record Key: 74ea49df-304f-4698-bada-c0977c1419d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RIVA SC
• Version Model Number: RIVA SC A3.5 REG 50 CAP
• Catalog Number: 8600004
• 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	DO3686000040 [Unit of Use]
HIBCC	DO3686000041 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030516

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: 2016-09-30

On-Brand Devices [RIVA SC]

• DO3686300041: RIVA SC HV A3.5 50 CAP
• DO3686300031: RIVA SC HV A3 50 CAP
• DO3686300021: RIVA SC HV A2 50 CAP
• DO3686300011: RIVA SC HV A1 50 CAP
• DO3686200071: RIVA SC STARTER FAST KT A2
• DO3686200061: RIVA SC STARTER FAST KT A1
• DO3686200051: RIVA SC STARTER REG KT A2
• DO3686200041: RIVA SC STARTER REG KT A1
• DO3686200001: RIVA SC CAP FAST ASSTD KT
• DO3686105231: RIVA SC T-A3.5 P/L KT REG 15G
• DO3686105221: RIVA SC T-A3 P/L KT REG 15G
• DO3686105211: RIVA SC T-A2 P/L KT REG 15G
• DO3686105081: RIVA SC B3 P/L KT
• DO3686105071: RIVA SC B2 P/L KT
• DO3686105051: RIVA SC A4 P/L KT
• DO3686105041: RIVA SC A3.5 P/L KT
• DO3686105031: RIVA SC A3 P/L KT
• DO3686105021: RIVA SC A2 P/L KT
• DO3686105011: RIVA SC A1 P/L KT
• DO3686101081: RIVA SC B3 PWD REF 15G
• DO3686101051: RIVA SC A4 PWD REF 15G
• DO3686101031: RIVA SC A3 PWD REF 15G
• DO3686101021: RIVA SC A2 PWD REF 15G
• DO3686101011: RIVA SC A1 PWD REF 15G
• DO3686100001: RIVA SC CAP REG ASSTD KT
• DO3686050081: RIVA SC B3 FAST 50 CAP
• DO3686050071: RIVA SC B2 FAST 50 CAP
• DO3686050051: RIVA SC A4 FAST 50 CAP
• DO3686050041: RIVA SC A3.5 FAST 50 CAP
• DO3686050031: RIVA SC A3 FAST 50 CAP
• DO3686050021: RIVA SC A2 FAST 50 CAP
• DO3686050011: RIVA SC A1 FAST 50 CAP
• DO3686000131: RIVA SC T-A3.5 FAST 50 CAP
• DO3686000121: RIVA SC T-A3 FAST 50 CAP
• DO3686000111: RIVA SC T-A2 FAST 50 CAP
• DO3686000081: RIVA SC B3 REG 50 CAP
• DO3686000071: RIVA SC B2 REG 50 CAP
• DO3686000051: RIVA SC A4 REG 50 CAP
• DO3686000041: RIVA SC A3.5 REG 50 CAP
• DO3686000031: RIVA SC A3 REG 50 CAP
• DO3686000021: RIVA SC A2 REG 50 CAP
• DO3686000011: RIVA SC A1 REG 50 CAP