3wedge 7505

GUDID E29975059

wood wedges, Jumbo, 500 pcs

Polydentia SA

Dental wedge, single-use

• Primary Device ID: E29975059
• NIH Device Record Key: 9bab9e33-5305-49c7-98bf-fe72ce29fb07
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3wedge
• Version Model Number: 7505
• Catalog Number: 7505
• Company DUNS: 481461598
• Company Name: Polydentia SA
• Device Count: 500
• 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: true
• 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	E29975050 [Primary]
HIBCC	E29975059 [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: 2025-05-29
• Device Publish Date: 2025-05-21

On-Brand Devices [3wedge]

• E29975059: wood wedges, Jumbo, 500 pcs
• E29975049: wood wedges, Large,500 pcs
• E29975039: wood wedges, Skinny, 500 pcs
• E29975029: wood wedges, Small, 500 pcs
• E29975010: wood wedges, Assorted, 100 pcs.
• E29975000: wood wedges, Assorted, 500 pcs.