Fiber-Splint Ortho evolution

GUDID E29959790

Polydentia SA

Dental reinforcing fibre

• Primary Device ID: E29959790
• NIH Device Record Key: f1c65f52-9eef-4a64-8e7a-5487cf8b1d33
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fiber-Splint Ortho evolution
• Version Model Number: 5979
• Company DUNS: 481461598
• Company Name: Polydentia SA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: 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	E29959790 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K962374

FDA Product Code

• EBI: Resin, Denture, Relining, Repairing, Rebasing

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-28

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