Set PP 8805102

GUDID DO3688051021

SDI LIMITED

Dental composite resin

• Primary Device ID: DO3688051021
• NIH Device Record Key: 6db849b5-4a61-460d-b84b-a4b108719733
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Set PP
• Version Model Number: SET PP A2 SYR 2 PK
• Catalog Number: 8805102
• Company DUNS: 753221852
• Company Name: SDI LIMITED
• Device Count: 2
• 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: false
• 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	DO3688051020 [Unit of Use]
HIBCC	DO3688051021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073043

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 PP]

• DO3688100061: SET PP ENDO TIPS
• DO3688100051: SET PP INTRA-ORAL TIPS
• DO3688100041: SET PP MIXING TIPS (WIDE)
• DO3688100031: SET PP MIXING TIPS (REGULAR)
• DO3688100021: SET PP ASSTD 5 SYR
• DO3688051051: SET PP TRANSLUCENT SYR 2 PK
• DO3688051041: SET PP WHT/OPQ SYR 2 PK
• DO3688051031: SET PP OA3 SYR 2 PK
• DO3688051021: SET PP A2 SYR 2 PK
• DO3688051011: SET PP A1 SYR 2 PK