FDA applicant

Denali R&D Corporation

Hanover, MA2 decisions2009–20090 recalls

FDA records 2 decisions for Denali R&D Corporation (Hanover, MA) in 2009: 2 510(k) clearances. Most are in product codes EMA (Cement, Dental) and EBC (Sealant, Pit And Fissure, And Conditioner). 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 Denali R&D Corporation’s devices, and how often a recall has named them.

FDA decisions per year

2in 2009

2009high 2 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Denali R&D Corporation by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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See the 510(k) Report

Other applicant names beginning “Denali”

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

Denali Corporation 9

Denali R&D Corporation

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Denali”