FDA applicant

Novocol Inc. Dba Septodont and Confi-Dental Produc

Louisville, CO2 decisions2010–20110 recalls

FDA records 2 decisions for Novocol Inc. Dba Septodont and Confi-Dental Produc (Louisville, CO) from 2010 to 2011: 2 510(k) clearances. Most are in product codes EBF (Material, Tooth Shade, Resin) 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 Novocol Inc. Dba Septodont and Confi-Dental Produc’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2010high 1 (2010) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Novocol Inc. Dba Septodont and Confi-Dental Produc by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Novocol Inc. Dba Septodont and…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Novocol”

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

Novocol, Inc. 9

Novocol Inc. Dba Septodont and Confi-Dental Produc

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Novocol”