Orange wood wedges 5018PLUS

GUDID E2995018PLUS9

Polydentia SA

Dental wedge, single-use

• Primary Device ID: E2995018PLUS9
• NIH Device Record Key: 41a68e29-054f-4533-ae38-f8076a63a078
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Orange wood wedges
• Version Model Number: 5018PLUS
• Catalog Number: 5018PLUS
• Company DUNS: 481461598
• Company Name: Polydentia SA
• Device Count: 1000
• 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	E2995018PLUS0 [Primary]
HIBCC	E2995018PLUS9 [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: 2025-06-24
• Device Publish Date: 2025-06-16

On-Brand Devices [Orange wood wedges]

• E29950189: 11.5 mm 200 pcs
• E2995018S9: 5018S
• E2995018PLUS9: 5018PLUS
• E2995018MN9: 5018MN