FDA applicant

Dentsply Interntional

York, PA13 decisions2007–20090 recalls

FDA records 13 decisions for Dentsply Interntional (York, PA) from 2007 to 2009: 13 510(k) clearances. Most are in product codes NJM (Bracket, Ceramic, Orthodontic) and KIF (Resin, Root Canal Filling). Its devices cite 23 predicates, 4 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 Dentsply Interntional’s devices, and how often a recall has named them.

FDA decisions per year

4in 2009

2007high 7 (2008) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Dentsply Interntional by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Dentsply Interntional’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 “Dentsply”

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

Dentsply Intl. 291 Dentsply Sirona 88 Dentsply International, Inc. 59 Dentsply Midwest 1 Dentsply Implant 1 Dentsply Implants Manufacturing GmbH 1 Dentsply Ceramco 1 Dentsply Gendex 1

Dentsply Interntional

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 “Dentsply”