510(k) Report

FDA applicant

Delsan Dental Systems

Pennington, NJ2 decisions1992–19920 recalls

FDA records 2 decisions for Delsan Dental Systems (Pennington, NJ) in 1992: 2 510(k) clearances. Most are in product codes EIE (Dam, Rubber) and DYN (Mouthpiece, Saliva Ejector). 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 Delsan Dental Systems’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Delsan Dental Systems since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Delsan Dental Systems’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?

  • EIEDam, Rubber1decision
  • DYNMouthpiece, Saliva Ejector1decision

What has FDA decided for it lately?

  • K921771Minidam IIDelsan Dental Systems · 1992
  • K921117MinidamDelsan Dental Systems · 1992

All 2 as Delsan Dental Systems →