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artBloc Temp

by Merz Dental GmbH 102 variants

artBloc Temp (1017651) 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 D7091017651), active as of 21 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 21 Oct 2026

Documents

510(k) K080556

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 21 Oct 2026.

Regulatory status

as of registry sync 21 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberD7091017651 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK080556 Date2 May 2008DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K080556 decided 2 May 2008 Active
  • FDA GUDID UDI-DI D7091017651 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K080556
  2. Listed FDA GUDID D7091017651

Coverage

1 jurisdiction

United States of America
  • 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  • Withdrawn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 A2 translucent, 1017651
Primary DI / UDI-DI
D7091017651
510(k) Number
FDA product code
EBG
GMDN term
Temporary dental crown/bridge
Device class
Class II
Regulation number
872.3770
GUDID distribution status
In Commercial Distribution

Related devices

Category: Temporary dental crown/bridge

Cleared under the same submission (K080556)

and 8 more cleared under K080556

Other devices from Merz Dental GmbH

See all devices from Merz Dental GmbH →

Properties

  • Lot / batch number
  • Expiration date
Other properties (13, all answered No)