AURA 8565001

GUDID DO3685650011

SDI LIMITED

Dental pit/fissure sealant

• Primary Device ID: DO3685650011
• NIH Device Record Key: 43a912b4-b703-4a64-9306-da746c06646e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AURA
• Version Model Number: AURA 20 COMP E1
• Catalog Number: 8565001
• Company DUNS: 753221852
• Company Name: SDI LIMITED
• Device Count: 20
• 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
• 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
• 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
• 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	DO3685650010 [Unit of Use]
HIBCC	DO3685650011 [Primary]

FDA Product Code

• EBF: MATERIAL, TOOTH SHADE, 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: 4
• Public Version Date: 2019-12-16
• Device Publish Date: 2016-09-30

On-Brand Devices [AURA]

• DO3685651071: AURA COMP MULTIPURPOSE KIT
• DO3685651061: AURA SYR MULTIPURPOSE KIT
• DO3685651051: AURA COMP STARTER KIT - MEDIUM
• DO3685651041: AURA SYR STARTER KIT - MEDIUM
• DO3685651031: AURA COMP STARTER KIT - LIGHT
• DO3685651021: AURA SYR STARTER KIT - LIGHT
• DO3685651001: AURA SYR MASTER INTRO KT
• DO3685650171: AURA 20 COMP MC5
• DO3685650161: AURA 20 COMP MC4
• DO3685650151: AURA 20 COMP MC3
• DO3685650141: AURA 20 COMP MC2
• DO3685650121: AURA 20 COMP BULK FILL
• DO3685650111: AURA 20 COMP DB
• DO3685650101: AURA 20 COMP DC7
• DO3685650091: AURA 20 COMP DC6
• DO3685650081: AURA 20 COMP DC5
• DO3685650071: AURA 20 COMP DC4
• DO3685650061: AURA 20 COMP DC3
• DO3685650051: AURA 20 COMP DC2
• DO3685650041: AURA 20 COMP DC1
• DO3685650031: AURA 20 COMP E3
• DO3685650021: AURA 20 COMP E2
• DO3685650011: AURA 20 COMP E1
• DO3685600171: AURA SYR MC5
• DO3685600161: AURA SYR MC4
• DO3685600151: AURA SYR MC3
• DO3685600141: AURA SYR MC2
• DO3685600121: AURA SYR BULK FILL
• DO3685600111: AURA SYR DB
• DO3685600101: AURA SYR DC7
• DO3685600091: AURA SYR DC6
• DO3685600081: AURA SYR DC5
• DO3685600071: AURA SYR DC4
• DO3685600061: AURA SYR DC3
• DO3685600051: AURA SYR DC2
• DO3685600041: AURA SYR DC1
• DO3685600031: AURA SYR E3
• DO3685600021: AURA SYR E2
• DO3685600011: AURA SYR E1
• DO3685651111: AURA STARTER MEDIUM SHADE GUIDE KT
• DO3685651101: AURA MULTI CHROMA SHADE GUIDE KT
• DO3685651091: AURA STARTER LIGHT SHADE GUIDE KT
• DO3685651081: AURA MASTER SHADE GUIDE KT
• 09336472037260: AURA COMP STARTER KIT - LIGHT
• 09336472032166: AURA STARTER MEDIUM SHADE GUIDE KT
• 09336472032159: AURA MASTER SHADE GUIDE KT
• 09336472030803: AURA SYR BULK FILL
• 09336472015510: AURA SYR MASTER INTRO KT
• 09336472015503: AURA 20 COMP DB
• 09336472015473: AURA 20 COMP DC5