Unica Proximal 6913

GUDID E29969139

anterior matrices

Polydentia SA

Dental matrix band, single-use

• Primary Device ID: E29969139
• NIH Device Record Key: 791ba0e9-88ab-4692-97fb-d24b6c3dc6da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Unica Proximal
• Version Model Number: 6913
• Catalog Number: 6913
• Company DUNS: 481461598
• Company Name: Polydentia SA
• Device Count: 100
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E29969130 [Primary]
HIBCC	E29969139 [Unit of Use]

FDA Product Code

• DZN: Instruments, Dental Hand

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: 2025-05-07
• Device Publish Date: 2025-04-29

On-Brand Devices [Unica Proximal ]

• E29969149: anterior matrices
• E29969139: anterior matrices