VisCalor

FDA UDI

Class II (US FDA UDI)

by VOCO GmbH

Identity

Trade Name: VisCalor FDA UDI
Generic Name: Dentine bonding agent/set FDA UDI
Device Name: VisCalor is a light-curing, radiopaque, nano-hybrid restorative material. Set contains Futurabond U FDA UDI
Model / Reference: 6108 FDA UDI
Description: VisCalor is a light-curing, radiopaque, nano-hybrid restorative material. Set contains Futurabond U FDA UDI

Identifiers

Catalog Number: 6108 FDA UDI
Primary DI / UDI-DI: E22161081 FDA UDI
510(k) Number: K130486 FDA UDI
K201307 FDA UDI
FDA Product Code: EMA FDA UDI
KLE FDA UDI
EBF FDA UDI
GMDN Term: Dentine bonding agent/set FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3275 FDA UDI
872.3200 FDA UDI
872.3690 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

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

FDA UDI

Category: Dental composite resin Dentine bonding agent/set

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

Similar devices

Also classified as Dentine bonding agent/set.

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Tooth Shade Resin Material — Liaoning Upcera Co., Ltd. · Class II
Tooth Shade Resin Material — Liaoning Upcera Co., Ltd. · Class II
Tooth Shade Resin Material — Liaoning Upcera Co., Ltd. · Class II
Tooth Shade Resin Material — Liaoning Upcera Co., Ltd. · Class II
Tooth Shade Resin Material — Liaoning Upcera Co., Ltd. · Class II
Tooth Shade Resin Material — Liaoning Upcera Co., Ltd. · Class II
Tooth Shade Resin Material — Liaoning Upcera Co., Ltd. · Class II

Cleared under the same submission

K130486 also covers:

Admira Fusion — VOCO GmbH
Futurabond U — VOCO GmbH

K201307 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 b65d0f02-6a8e-4c83-8b3c-97190b1c360c 37 fields · synced May 30, 2026