510(k) Report

FDA applicant

Inpharma A.S.

Northborough, MA3 decisions1995–20030 recalls

FDA records 3 decisions for Inpharma A.S. (Northborough, MA) from 1995 to 2003: 3 510(k) clearances. Most are in product codes LFD (Saliva, Artificial) and LBH (Varnish, Cavity). Its devices cite 2 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Inpharma”.

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 Inpharma A.S.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Inpharma A.S. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • LFDSaliva, Artificial2decisions
  • LBHVarnish, Cavity1decision

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 23 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K945794DuraphatInpharma · 19958cite it
  • K991938Caphosol Artificial SalivaInpharma A.S. · 19998cite it
  • K030802CaphosolInpharma A.S. · 20037cite it

What has FDA decided for it lately?

  • K030802CaphosolInpharma A.S. · 2003
  • K991938Caphosol Artificial SalivaInpharma A.S. · 1999
  • K945794DuraphatInpharma · 1995

All 2 as Inpharma A.S. →The one decision as Inpharma →