510(k) Report

FDA applicant

Roeko Ulm, Roescheisen GmbH & Co.

Concord, MA1 decision1998–19980 recalls

FDA records 1 decision for Roeko Ulm, Roescheisen GmbH & Co. (Concord, MA) in 1998: 1 510(k) clearance. All are in product code KIF (Resin, Root Canal Filling). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided Roeko Ulm, Roescheisen GmbH & Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Roeko Ulm, Roescheisen GmbH & Co. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Roeko Ulm, Roescheisen GmbH & Co. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KIFResin, Root Canal Filling1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K983037Roeko SealRoeko Ulm, Roescheisen GmbH & Co. · 19981cites it

What has FDA decided for it lately?

  • K983037Roeko SealRoeko Ulm, Roescheisen GmbH & Co. · 1998

The one decision as Roeko Ulm, Roescheisen GmbH & Co. →

Other applicant names beginning “Roeko”

FDA records each applicant name separately; these may or may not be the same firm.

Roeko USA, Inc. 1Roeko 1