CONSEAL 7850016

GUDID DO3678500161

SDI LIMITED

Dental pit/fissure sealant

• Primary Device ID: DO3678500161
• NIH Device Record Key: 696b613b-fc2b-4979-8f45-b2fd93ce75b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CONSEAL
• Version Model Number: CONSEAL CLEAR 4 SYR KT
• Catalog Number: 7850016
• Company DUNS: 753221852
• Company Name: SDI LIMITED
• Device Count: 4
• 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: 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 10 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	DO3678500160 [Unit of Use]
HIBCC	DO3678500161 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K990650

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: 2016-09-27

On-Brand Devices [CONSEAL]

• DO3678500161: CONSEAL CLEAR 4 SYR KT
• DO3678500131: CONSEAL F SYR BULK KT
• DO3678500121: CONSEAL F SYR KT
• DO3678500081: CONSEAL F KT
• DO3678500061: CONSEAL F 5ML