Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K231696Ref 20006-2Model Restorative Material

by Prevest Denpro Limited

Identity

Trade Name: Fusion Universal EUDAMED
Device Name: Fusion Universal EUDAMED
Model / Reference: Restorative Material EUDAMED
20006-2 EUDAMED

Identifiers

Primary DI / UDI-DI: +D96720006200 EUDAMED
Basic UDI-DI: B-+D96720006200 EUDAMED
510(k) Number: K231696 FDA 510(k)
FDA Product Code: KLE FDA 510(k)
EMDN Code: Q01010103 DENTAL RESTORATIVE COMPOSITES EUDAMED

Classification

Device Class: Class IIa EUDAMED
Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 872.3200 FDA 510(k)
Regulation Number: 872.3200 FDA 510(k)
Market of Registration: Cyprus EUDAMED
Advisory Committee: Dental FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

Clinical & Handling

Sterile

EUDAMED

Implantable

EUDAMED

Reusable

EUDAMED

Contains Latex

EUDAMED

Reprocessed

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

The Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, and Renew Universal are dental resin agents used for bonding and restoring teeth. These devices adhere to tooth surfaces, providing structural reinforcement and aesthetic restoration in restorative dentistry procedures.

Supplied as single-use kits, these agents are intended for use in dental clinics and offices. They are classified as Class II devices under FDA regulations and comply with the Medical Device Directive (MDD). The products are non-sterile and require proper handling and storage as per manufacturer instructions to maintain efficacy.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDD	—	Class II	Active
FDA 510(k)	United States	FDA_510K	K231696	Class II	Active

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

Manufacturer

Manufacturer: Prevest Denpro Limited

Sources (2)

FDA 510(k) K231696 24 fields · synced Oct 6, 2026
EUDAMED 1a8f1186-1572-453a-9161-5b685cef3d32 61 fields · synced Jul 8, 2026