Admira Fusion

FDA UDI

Class II (US FDA UDI)

by VOCO GmbH

Identity

Trade Name: Admira Fusion FDA UDI
Generic Name: Dentine adhesive FDA UDI
Device Name: Universal nanohybrid ORMOCER restorative material. This kit contains different shades of Admira Fusion, Admira Fusion x-tra and Futurabond U. FDA UDI
Model / Reference: 2780 FDA UDI
Description: Universal nanohybrid ORMOCER restorative material. This kit contains different shades of Admira Fusion, Admira Fusion x-tra and Futurabond U. FDA UDI

Identifiers

Catalog Number: 2780 FDA UDI
Primary DI / UDI-DI: E22127801 FDA UDI
510(k) Number: K130486 FDA UDI
K150784 FDA UDI
K151956 FDA UDI
FDA Product Code: KLE FDA UDI
EMA FDA UDI
EBF FDA UDI
GMDN Term: Dentine adhesive FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3200 FDA UDI
872.3275 FDA UDI
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

Yes

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

FDA UDI

Category: Dental composite resin Dentine adhesive

Admira Fusion by VOCO GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dentine adhesive.

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Xeno® IV One Component Light Cured Self-Etching Dental Adhesive — Dentsply International · Class II
SciPharm Cure-On Touch Orthodontic Adhesive — SCIENTIFIC PHARMACEUTICALS, INC. · Class II
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Cleared under the same submission

K130486 also covers:

Futurabond U — VOCO GmbH
VisCalor — VOCO GmbH

K150784 also covers:

K151956 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

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Manufacturer

Manufacturer: VOCO GmbH

Sources (1)

FDA UDI 541e5db7-63df-4ef9-b6c7-3340a574c6d3 37 fields · synced May 30, 2026