Traxodent

GUDID 00348783013283

Traxodent Unit Dose Value Pack

PREMIER DENTAL PRODUCTS COMPANY

Gingival retraction solution

• Primary Device ID: 00348783013283
• NIH Device Record Key: a8e6a981-6609-4598-bb64-58648524fe99
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Traxodent
• Version Model Number: 9007090
• 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: true
• 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	00348783013283 [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: 2025-02-07
• Device Publish Date: 2025-01-30

On-Brand Devices [Traxodent]

• D691TRAEMB60: Itena Traxodent Applicator Tip Qty 60
• D691TRAEMB20: Itena Traxodent Applicator Tip Qty 20
• D6919007092: Traxodent Applicator Tip
• 00348783013283: Traxodent Unit Dose Value Pack