Z-Dent Anterior 2285328

GUDID 10304040000875

Z-Dent Anterior

HENRY SCHEIN, INC.

Resin artificial teeth

• Primary Device ID: 10304040000875
• NIH Device Record Key: 4397e9f1-d167-4170-9e9f-172ce89db4f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Z-Dent Anterior
• Version Model Number: 2285328
• Catalog Number: 2285328
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 23 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00304040000878 [Primary]
GS1	10304040000875 [Package]; Contains: 00304040000878; Package: BOX [20 Units]; In Commercial Distribution

FDA Product Code

• ELM: Denture, plastic, teeth

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-24

Devices Manufactured by HENRY SCHEIN, INC.

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• 00304040186558 - Henry Schein: 2024-10-09 Pack General PGYBK F/ Dr James Paul
• 10304040186562 - Henry Schein: 2024-10-09 Pack Total Joint F/ Capital Ortho
• 00304040186572 - Henry Schein: 2024-10-09 Pack Shoulder
• 00304040186589 - Henry Schein: 2024-10-09 Pack Knee F/ Capital Ortho
• 10304040186708 - Henry Schein: 2024-10-09 Pack Total Joint F/ Garden State Surgical Center