Fiber-Splint ML Mini Starter Kit

Basic Information

• Brand Name: Fiber-Splint ML Mini Starter Kit
• Primary DI: E29959760
• Version / Model: 5976
• Company Name: Polydentia SA
• Labeler DUNS: 481461598
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-28
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: eccc52bf-300b-41da-88bb-bee78f2ea76c

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	872.3760	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44786	Dental reinforcing fibre	A device used in general restorative dentistry and orthodontic treatment typically as reinforcement of dental polymer-based materials, used for the construction of dental prostheses, i.e., splints, posts, crowns, and bridges. This device is typically made of polyethylene (PE) fibres supplied in strands, braid, or ribbon in a variety of sizes. It may also be used for the stabilization of avulsed teeth maintaining diastema closures or split-tooth syndrome. The ultrahigh molecular weight PE fibres increase the strength of composite materials, and provide improved safety by assisting in the retention of pieces in the event that a dental prosthesis is broken. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	E29959760	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K962374	000