510(k) Report

FDA applicant

Oroscience, Inc.

North Attleboro, MA2 decisions2008–20090 recalls

FDA records 2 decisions for Oroscience, Inc. (North Attleboro, MA) from 2008 to 2009: 2 510(k) clearances. Most are in product codes EMA (Cement, Dental) and GEX (Powered Laser Surgical Instrument). Its devices cite 8 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 Oroscience, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2008: 12009: 1
2008high 1 (2008) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Oroscience, Inc. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Oroscience, Inc.’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?

  • EMACement, Dental1decision
  • GEXPowered Laser Surgical Instrument1decision

Whose devices does it build on?

Its devices cite 8 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K083516PeriogenixOroscience, Inc. · 20091cites it

What has FDA decided for it lately?

  • K083516PeriogenixOroscience, Inc. · 2009
  • K082445CURATIVE980 Diode LaserOroscience, Inc. · 2008

All 2 as Oroscience, Inc. →