ICE 8400019

GUDID DO3684000191

SDI LIMITED

Dental pit/fissure sealant

• Primary Device ID: DO3684000191
• NIH Device Record Key: 7cb62a47-a1e3-4c6a-b438-ebd62b869717
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ICE
• Version Model Number: ICE 1 SYR I
• Catalog Number: 8400019
• Company DUNS: 753221852
• Company Name: SDI LIMITED
• Device Count: 1
• 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	DO3684000191 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012528

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-29

On-Brand Devices [ICE]

• DO3684500211: ICE 20 COMP OA2
• DO3684500191: ICE 20 COMP I
• DO3684500181: ICE 20 COMP B
• DO3684500171: ICE 20 COMP D4
• DO3684500161: ICE 20 COMP D3
• DO3684500151: ICE 20 COMP D2
• DO3684500121: ICE 20 COMP C3
• DO3684500111: ICE 20 COMP C2
• DO3684500101: ICE 20 COMP C1
• DO3684500081: ICE 20 COMP B3
• DO3684500071: ICE 20 COMP B2
• DO3684500061: ICE 20 COMP B1
• DO3684500051: ICE 20 COMP A4
• DO3684500041: ICE 20 COMP A3.5
• DO3684500031: ICE 20 COMP A3
• DO3684500021: ICE 20 COMP A2
• DO3684500011: ICE 20 COMP A1
• DO3684001031: ICE COMP INTRO KT
• DO3684001001: ICE SYR INTRO KT
• DO3684000231: ICE 1 SYR OA3.5
• DO3684000221: ICE 1 SYR OA3
• DO3684000211: ICE 1 SYR OA2
• DO3684000191: ICE 1 SYR I
• DO3684000181: ICE 1 SYR B
• DO3684000171: ICE 1 SYR D4
• DO3684000161: ICE 1 SYR D3
• DO3684000151: ICE 1 SYR D2
• DO3684000121: ICE 1 SYR C3
• DO3684000111: ICE 1 SYR C2
• DO3684000101: ICE 1 SYR C1
• DO3684000081: ICE 1 SYR B3
• DO3684000071: ICE 1 SYR B2
• DO3684000061: ICE 1 SYR B1
• DO3684000051: ICE 1 SYR A4
• DO3684000041: ICE 1 SYR A3.5
• DO3684000031: ICE 1 SYR A3
• DO3684000021: ICE 1 SYR A2
• DO3684000011: ICE 1 SYR A1