GLACIER 7450002

GUDID DO3674500021

SDI LIMITED

Dental pit/fissure sealant

• Primary Device ID: DO3674500021
• NIH Device Record Key: a0c5cf43-cec3-4d29-8460-840d647ae8b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GLACIER
• Version Model Number: GLACIER 20 COMP A2
• Catalog Number: 7450002
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	DO3674500020 [Unit of Use]
HIBCC	DO3674500021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K941899

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: 2016-09-28

On-Brand Devices [GLACIER]

• DO3674541511: GLACIER 20 COMP B
• DO3674500201: GLACIER 20 COMP OC2
• DO3674500171: GLACIER 20 COMP OA3.5
• DO3674500151: GLACIER 20 COMP OA2
• DO3674500141: GLACIER 20 COMP I
• DO3674500131: GLACIER 20 COMP D3
• DO3674500121: GLACIER 20 COMP C4
• DO3674500111: GLACIER 20 COMP C3
• DO3674500101: GLACIER 20 COMP C2
• DO3674500091: GLACIER 20 COMP B4
• DO3674500081: GLACIER 20 COMP B3
• DO3674500071: GLACIER 20 COMP B2
• DO3674500061: GLACIER 20 COMP B1
• DO3674500051: GLACIER 20 COMP A4
• DO3674500041: GLACIER 20 COMP A3.5
• DO3674500031: GLACIER 20 COMP A3
• DO3674500021: GLACIER 20 COMP A2
• DO3674500011: GLACIER 20 COMP A1
• DO3670300011: GLACIER COMP INTRO KT
• DO3670151511: GLACIER 1 SYR B
• DO3670141421: GLACIER 1 SYR I
• DO3670133351: GLACIER 1 SYR OD3
• DO3670133341: GLACIER 1 SYR D3
• DO3670124261: GLACIER 1 SYR OC4
• DO3670124251: GLACIER 1 SYR C4
• DO3670123241: GLACIER 1 SYR C3
• DO3670122241: GLACIER 1 SYR OC2
• DO3670122231: GLACIER 1 SYR C2
• DO3670114161: GLACIER 1 SYR OB4
• DO3670114151: GLACIER 1 SYR B4
• DO3670113151: GLACIER 1 SYR OB3
• DO3670113141: GLACIER 1 SYR B3
• DO3670112111: GLACIER 1 SYR B2
• DO3670111121: GLACIER 1 SYR B1
• DO3670105061: GLACIER 1 SYR A4
• DO3670104061: GLACIER 1 SYR OA3.5
• DO3670104051: GLACIER 1 SYR A3.5
• DO3670103051: GLACIER 1 SYR OA3
• DO3670103041: GLACIER 1 SYR A3
• DO3670102041: GLACIER 1 SYR OA2
• DO3670102031: GLACIER 1 SYR A2
• DO3670101021: GLACIER 1 SYR A1
• DO3670000051: GLACIER 5 SYR KT