Traxodent - Itena 7007093

GUDID 00348783001013

Traxodent Starter Pack - ITENA

PREMIER DENTAL PRODUCTS COMPANY

Gingival retraction solution

• Primary Device ID: 00348783001013
• NIH Device Record Key: afd83e60-4477-4514-8e33-fa1e947f2413
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Traxodent - Itena
• Version Model Number: TRABOI-7
• Catalog Number: 7007093
• Company DUNS: 014789663
• Company Name: PREMIER DENTAL PRODUCTS COMPANY
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00348783001013 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083695

FDA Product Code

• MVL: Cord, Retraction

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-24
• Device Publish Date: 2023-10-16

On-Brand Devices [Traxodent - Itena]

• 00348783001020: Traxodent Trial (2 pack) - ITENA
• 00348783001013: Traxodent Starter Pack - ITENA
• 00348783001006: Traxodent Value Pack - ITENA