artBloc Temp

FDA UDI

Class II (US FDA UDI)

by Merz Dental GmbH

Identity

Trade Name: artBloc Temp FDA UDI
Generic Name: Temporary dental crown/bridge FDA UDI
Device Name: 10 artBloc Temp, PMMA-bloc 15,5x19,0x39,0mm shade B3 translucent FDA UDI
Model / Reference: 10 artBloc Temp, PMMA-bloc 15,5x19,0x39,0mm shade B3 translucent FDA UDI
Description: 10 artBloc Temp, PMMA-bloc 15,5x19,0x39,0mm shade B3 translucent FDA UDI

Identifiers

Catalog Number: 1017657 FDA UDI
Primary DI / UDI-DI: D7091017657 FDA UDI
510(k) Number: K080556 FDA UDI
FDA Product Code: EBG FDA UDI
GMDN Term: Temporary dental crown/bridge FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3770 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

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: Temporary dental crown/bridge

artBloc Temp by Merz Dental GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Temporary dental crown/bridge.

Visalys Temp — Kettenbach GmbH & Co. KG · Class II
VIPI BLOCK — Vipi Indústria, Comércio, Exportação e Importação de Produtos Odontológicos Ltda. · Class II
VIPI BLOCK — Vipi Indústria, Comércio, Exportação e Importação de Produtos Odontológicos Ltda. · Class II
IDODENTINE — UNION DENTAL SA · Class II
10TEMP — UNION DENTAL SA · Class II
Pure PMMA Disc — QUEST DENTAL MATERIAL CORPORATION · Class II
Pure PMMA Disc — QUEST DENTAL MATERIAL CORPORATION · Class II
Pure PMMA Disc — QUEST DENTAL MATERIAL CORPORATION · Class II

Cleared under the same submission

K080556 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: Merz Dental GmbH

Sources (1)

FDA UDI b5d8c917-24a2-4daa-aceb-1da8239380ab 36 fields · synced May 30, 2026