Fusion Flo SE

FDA UDI

Class II (US FDA UDI)

by Prevest Denpro Limited

Identity

Trade Name: Fusion Flo SE FDA UDI
Generic Name: Dental composite resin kit FDA UDI
Model / Reference: Intro Pack Box FDA UDI

Identifiers

Catalog Number: 20008-5 FDA UDI
Primary DI / UDI-DI: D967200085 FDA UDI
510(k) Number: K231263 FDA UDI
FDA Product Code: EBF FDA UDI
GMDN Term: Dental composite resin kit FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3690 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental composite resin kit

Fusion Flo SE by Prevest Denpro Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

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

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Manufacturer

Manufacturer: Prevest Denpro Limited

Sources (1)

FDA UDI ec760d8b-299d-4f8e-aeae-cc6e10605ffe 34 fields · synced May 30, 2026