Set 8805003

GUDID DO3688050031

SDI LIMITED

Dental composite resin

• Primary Device ID: DO3688050031
• NIH Device Record Key: 58ec8ebe-02c1-4f55-b009-a3588afa5065
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Set
• Version Model Number: SET OA3 50 CAP
• Catalog Number: 8805003
• 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	DO3688050030 [Unit of Use]
HIBCC	DO3688050031 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051008

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 [Set]

• DO3688100001: SET ASSORTED KT
• DO3688050031: SET OA3 50 CAP
• DO3688050021: SET A2 50 CAP
• DO3688050011: SET A1 50 CAP