FDA applicant

White Peaks Dental Systems GmbH & Co. KG

Essen, DE3 decisions2009–20130 recalls

FDA records 3 decisions for White Peaks Dental Systems GmbH & Co. KG (Essen, DE) from 2009 to 2013: 3 510(k) clearances. Most are in product codes EIH (Powder, Porcelain) and EBG (Crown And Bridge, Temporary, Resin). Its devices cite 3 predicates, 0 of them its own earlier devices. 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 White Peaks Dental Systems GmbH & Co. KG’s devices, and how often a recall has named them.

FDA decisions per year

2in 2013

2009high 2 (2013) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — White Peaks Dental Systems GmbH & Co. KG by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like White Peaks Dental Systems GmbH & Co. KG’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “White”

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

White Knight Healthcare 8 White River Concepts 3 White River (Tm) 2 White-Rodgers, Div. Emerson Electric Co. 1

White Peaks Dental Systems GmbH & Co. KG

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “White”