FDA applicant

Dentsply Implants Manufacturing GmbH

San Diego, CA1 decision2013–20130 recalls

FDA records 1 decision for Dentsply Implants Manufacturing GmbH (San Diego, CA) in 2013: 1 510(k) clearance. All are in product code DZE (Implant, Endosseous, Root-Form). Its devices cite 8 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 Dentsply Implants Manufacturing GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Dentsply Implants Manufacturing GmbH by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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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 Interntional 13 Dentsply Midwest 1 Dentsply Implant 1 Dentsply Ceramco 1 Dentsply Gendex 1

Dentsply Implants Manufacturing GmbH

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”