510(k) Report

FDA applicant

Heka Dental A/S

Dk-2635 Ishoj, DK1 decision2015–20150 recalls

FDA records 1 decision for Heka Dental A/S (Dk-2635 Ishoj, DK) in 2015: 1 510(k) clearance. All are in product code EIA (Unit, Operative Dental). Its devices cite 1 predicate, 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 Heka Dental A/S’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2015: 1
2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Heka Dental A/S by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Heka Dental A/S’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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Which product codes does it file in?

  • EIAUnit, Operative Dental1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K150490UnicLine MobileHeka Dental A/S · 2015

The one decision as Heka Dental A/S →