510(k) Report

FDA applicant

Creodent Prosthetics, Ltd.

New York, NY9 decisions2013–20220 recalls

FDA records 9 decisions for Creodent Prosthetics, Ltd. (New York, NY) from 2013 to 2022: 9 510(k) clearances. Most are in product codes NHA (Abutment, Implant, Dental, Endosseous) and NXC (Aligner, Sequential). Since 2016 its 510(k)s took a median of 220 days from receipt to decision, against 188 for FDA’s reviews in the same codes and years. Its devices cite 13 predicates, 7 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 Creodent Prosthetics, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2022

2013: 12015: 12016: 12017: 22020: 12021: 12022: 2
2013high 2 (2017) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Creodent Prosthetics, Ltd. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Creodent”

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