510(k) Report

FDA applicant

Bladhs Plast AB

Pocono Manor, PA1 decision1998–19980 recalls

FDA records 1 decision for Bladhs Plast AB (Pocono Manor, PA) in 1998: 1 510(k) clearance. All are in product code EIA (Unit, Operative Dental). 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 Bladhs Plast AB’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bladhs Plast AB since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Bladhs Plast AB’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?

  • EIAUnit, Operative Dental1decision

What has FDA decided for it lately?

  • K980049BonetrapBladhs Plast AB · 1998

The one decision as Bladhs Plast AB →