Essential Dustless alginate 1127285

GUDID 10304040018719

Dental impression material

HENRY SCHEIN, INC.

Alginate dental impression material

• Primary Device ID: 10304040018719
• NIH Device Record Key: c4daef9f-06cb-4000-af14-3d1c55c0487e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Essential Dustless alginate
• Version Model Number: 1127285
• Catalog Number: 1127285
• Company DUNS: 012430880
• Company Name: HENRY SCHEIN, INC.
• 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: 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: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00304040018712 [Primary]
GS1	10304040018719 [Package]; Contains: 00304040018712; Package: CASE [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011785

FDA Product Code

• ELW: MATERIAL, IMPRESSION

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: 2016-09-24

On-Brand Devices [Essential Dustless alginate]

• 10304040018719: Dental impression material
• 10304040018702: Dental impression material