Durashield®

GUDID D687AD311012

Durashield® 5% Sodium Fluoride Varnish, Bubble Fun® 32 units of 0.40mL

Sultan Healthcare Inc

Dental cavity varnish

• Primary Device ID: D687AD311012
• NIH Device Record Key: ae311755-9219-4b40-ba06-4f1247d6d6b7
• Commercial Distribution Discontinuation: 2019-10-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Durashield®
• Version Model Number: AD31101
• Company DUNS: 056296981
• Company Name: Sultan Healthcare Inc
• Device Count: 32
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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: +1(800)989-8825
• Email: xx@xx.xx

Device Dimensions

• Total Volume: 0.4 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 30 Degrees Celsius and 0

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D687AD311010 [Unit of Use]
HIBCC	D687AD311011 [Primary]
HIBCC	D687AD311012 [Package]; Contains: D687AD311011; Package: Case [12 Units]; Discontinued: 2019-10-31; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K982915

FDA Product Code

• LBH: VARNISH, CAVITY

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-10-31
• Device Publish Date: 2016-09-23

On-Brand Devices [Durashield®]

• D687AD311022: Durashield® 5% Sodium Fluoride Varnish, Bubble Fun® 200 units of 0.40mL
• D687AD311012: Durashield® 5% Sodium Fluoride Varnish, Bubble Fun® 32 units of 0.40mL