artBloc Temp

by Merz Dental GmbH 102 variants

artBloc Temp (1017653) is a Class II device made by Merz Dental GmbH, cleared under FDA 510(k) K080556 on 2 May 2008 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI D7091017653), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	NumberD7091017653 UDI-DI	Date24 Sep 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK080556	Date2 May 2008Decided	StatusActive

Official records

FDA 510(k) database 510(k) number K080556

Across registries

2 registries list this device

FDA 510(k) K080556 decided 2 May 2008 Active
FDA GUDID UDI-DI D7091017653 listed 24 Sep 2016 Listed

Timeline

2 dated events

2 May 2008 Cleared FDA 510(k) K080556
24 Sep 2016 Listed FDA GUDID D7091017653

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name: Temporary dental crown/bridge
Model / Ref / Catalog: 10 artBloc Temp, PMMA-bloc 15, 5x19, 0x39, 0mm shade A3, 5 translucent, 1017653

Primary DI / UDI-DI: D7091017653
510(k) Number: K080556
FDA product code: EBG
GMDN term: Temporary dental crown/bridge

Device class: Class II
Regulation number: 872.3770
GUDID distribution status: In Commercial Distribution

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Properties

Lot / batch number
Expiration date

Other properties (13, all answered No)