Macro-Wedges

GUDID E29950300

assorted

Polydentia SA

Dental wedge, single-use

• Primary Device ID: E29950300
• NIH Device Record Key: 548a0a45-6703-4a31-964b-9dbeb74714c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Macro-Wedges
• Version Model Number: 5030
• Company DUNS: 481461598
• Company Name: Polydentia SA
• 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: 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

Customer Support Contacts

• Phone: +41919462948
• Email: info@polydentia.ch
• Phone: +41919462948
• Email: info@polydentia.ch
• Phone: +41919462948
• Email: info@polydentia.ch
• Phone: +41919462948
• Email: info@polydentia.ch
• Phone: +41919462948
• Email: info@polydentia.ch
• Phone: +41919462948
• Email: info@polydentia.ch
• Phone: +41919462948
• Email: info@polydentia.ch
• Phone: +41919462948
• Email: info@polydentia.ch
• Phone: +41919462948
• Email: info@polydentia.ch
• Phone: +41919462948
• Email: info@polydentia.ch
• Phone: +41919462948
• Email: info@polydentia.ch
• Phone: +41919462948
• Email: info@polydentia.ch
• Phone: +41919462948
• Email: info@polydentia.ch
• Phone: +41919462948
• Email: info@polydentia.ch
• Phone: +41919462948
• Email: info@polydentia.ch
• Phone: +41919462948
• Email: info@polydentia.ch
• Phone: +41919462948
• Email: info@polydentia.ch
• Phone: +41919462948
• Email: info@polydentia.ch
• Phone: +41919462948
• Email: info@polydentia.ch
• Phone: +41919462948
• Email: info@polydentia.ch
• Phone: +41919462948
• Email: info@polydentia.ch
• Phone: +41919462948
• Email: info@polydentia.ch
• Phone: +41919462948
• Email: info@polydentia.ch
• Phone: +41919462948
• Email: info@polydentia.ch
• Phone: +41919462948
• Email: info@polydentia.ch

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E29950300 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K790555

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: 2022-07-11
• Device Publish Date: 2022-07-01

Devices Manufactured by Polydentia SA

• E29975000 - 3wedge: 2025-05-29 wood wedges, Assorted, 500 pcs.
• E29975010 - 3wedge: 2025-05-29 wood wedges, Assorted, 100 pcs.
• E29975029 - 3wedge: 2025-05-29 wood wedges, Small, 500 pcs
• E29975039 - 3wedge: 2025-05-29 wood wedges, Skinny, 500 pcs
• E29975049 - 3wedge: 2025-05-29 wood wedges, Large,500 pcs
• E29975059 - 3wedge: 2025-05-29 wood wedges, Jumbo, 500 pcs
• E29969139 - Unica Proximal: 2025-05-07 anterior matrices
• E29969149 - Unica Proximal: 2025-05-07 anterior matrices