510(k) Report

FDA applicant

Digident, Ltd.

North Attleboro, MA1 decision1999–19990 recalls

FDA records 1 decision for Digident, Ltd. (North Attleboro, MA) in 1999: 1 510(k) clearance. All are in product code MUH (System, X-Ray, Extraoral Source, Digital). Its devices cite 3 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 Digident, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Digident, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Digident, Ltd.’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

Which product codes does it file in?

  • MUHSystem, X-Ray, Extraoral Source, Digital1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K990049CD-Dent Digital Imaging Devices for Dental X-Ray Systems, Models 600, 1000 and 2000Digident, Ltd. · 1999

The one decision as Digident, Ltd. →