STAE 8100205

GUDID DO3681002051

SDI LIMITED

Dentine bonding agent/set

• Primary Device ID: DO3681002051
• NIH Device Record Key: 039e36bc-9fbb-4268-8a88-81645e78a7f0
• Commercial Distribution Discontinuation: 2016-09-27
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: STAE
• Version Model Number: STAE SINGLEDOSE KT
• Catalog Number: 8100205
• 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: 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
• Phone: +18002285166
• Email: info@sdi.com.au
• Phone: +18002285166
• Email: info@sdi.com.au
• Phone: +18002285166
• Email: info@sdi.com.au
• Phone: +18002285166
• Email: info@sdi.com.au
• Phone: +18002285166
• Email: info@sdi.com.au
• Phone: +18002285166
• Email: info@sdi.com.au
• Phone: +18002285166
• Email: info@sdi.com.au
• Phone: +18002285166
• Email: info@sdi.com.au
• Phone: +18002285166
• Email: info@sdi.com.au
• Phone: +18002285166
• Email: info@sdi.com.au
• Phone: +18002285166
• Email: info@sdi.com.au
• Phone: +18002285166
• Email: info@sdi.com.au
• Phone: +18002285166
• Email: info@sdi.com.au

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 10 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	DO3681002050 [Unit of Use]
HIBCC	DO3681002051 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K973092

FDA Product Code

• KLE: AGENT, TOOTH BONDING, RESIN

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 [STAE]

• DO3681002051: STAE SINGLEDOSE KT
• DO3681002021: STAE INTRO KT 1X5ML
• DO3681002011: STAE 5ML PK
• 09336472012571: STAE INTRO KT 1X5ML
• 09336472012564: STAE 5ML PK