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

• E29963079 - myTines GO: 2024-08-27 extremities for myClip 2.0 and myRing Forte
• E29958059 - QuickmatFIT: 2024-02-06 anatomical sectional matrices 0.04mm premolar
• E29958069 - QuickmatFIT: 2024-02-06 anatomical sectional matrices 0.04mm molar
• E29958359 - QuickmatFIT: 2024-02-06 anatomical sectional matrices 0.04mm premolar
• E29958369 - QuickmatFIT: 2024-02-06 anatomical sectional matrices 0.04mm molar
• E29958469 - QuickmatFIT: 2024-02-06 anatomical sectional matrices 0.04mm molar deep
• E29958569 - QuickmatFIT: 2024-02-06 anatomical sectional matrices 0.04mm molar deep
• E29910989 - QuickmatFLEX sectional matrices: 2023-08-31 0.03 mm / 6.4 mm 10 pcs.