FDA applicant

Sulzer Dental, Inc.

Carlsbad, CA9 decisions2001–20022 recalls

FDA records 9 decisions for Sulzer Dental, Inc. (Carlsbad, CA) from 2001 to 2002: 9 510(k) clearances. Most are in product codes DZE (Implant, Endosseous, Root-Form) and NHA (Abutment, Implant, Dental, Endosseous). Its devices cite 15 predicates, 0 of them its own earlier devices. 2 recalls are 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 Sulzer Dental, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sulzer Dental, Inc. since 2007.

Recalls per year

1in 2017

2007high 1 (2014) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Sulzer Dental, Inc.’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 “Sulzer”

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

Sulzer Orthopedics, Inc. 45 Sulzer Calcitek, Inc. 9 Sulzer Spine-Tech 8 Sulzer Intratherapeutics, Inc. 8 Sulzer Carbomedics, Inc. 8 Sulzer Oscor, Inc. 2

Sulzer Dental, Inc.

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?

What has been recalled?

Other applicant names beginning “Sulzer”