Fiber-Splint ML Mini Starter Kit

FDA UDI

Class II (US FDA UDI)

by Polydentia SA

Identity

Trade Name: Fiber-Splint ML Mini Starter Kit FDA UDI
Generic Name: Dental reinforcing fibre FDA UDI
Model / Reference: 5976 FDA UDI

Identifiers

Primary DI / UDI-DI: E29959760 FDA UDI
510(k) Number: K962374 FDA UDI
FDA Product Code: EBI FDA UDI
GMDN Term: Dental reinforcing fibre FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3760 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Dental reinforcing fibre

Fiber-Splint ML Mini Starter Kit by Polydentia SA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental reinforcing fibre.

GlasSpan Flexible Ceramic Bonding Rope Large Refill — PRACTICON, INC. · Class II
Infibra — BIOLOREN SRL · Class II
everStick® — Gc America Inc. · Class II
everStick® — Gc America Inc. · Class II
ENFORCE FRC™ — G&H Wire Company, Inc. · Class II
Brasseler USA — Peter Brasseler Holdings, LLC · Class II
everStick® — Gc America Inc. · Class II
Dentapreg® INTRO — ADM, a.s. · Class II

Cleared under the same submission

K962374 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Polydentia SA

Sources (1)

FDA UDI eccc52bf-300b-41da-88bb-bee78f2ea76c 33 fields · synced Jun 1, 2026