510(k) Report

FDA applicant

The Stern Metals Co., Inc.

Attleboro, MA4 decisions1994–19960 recalls

FDA records 4 decisions for The Stern Metals Co., Inc. (Attleboro, MA) from 1994 to 1996: 4 510(k) clearances. Most are in product codes DZE (Implant, Endosseous, Root-Form) and EJS (Alloy, Other Noble Metal). 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 The Stern Metals Co., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for The Stern Metals Co., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — The Stern Metals Co., Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like The Stern Metals Co., 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?

  • DZEImplant, Endosseous, Root-Form3decisions
  • EJSAlloy, Other Noble Metal1decision

What has FDA decided for it lately?

  • K962301Sterngold G-Hard Metal AlloyThe Stern Metals Co., Inc. · 1996
  • K933193Impla-Med Ucla Type Abutments,Screwdriver,Reamer,LThe Stern Metals Co., Inc. · 1994
  • K926305Impla-Med Hex Screw Implants: 4,5 & 6MM DiameterThe Stern Metals Co., Inc. · 1994
  • K924219Endosseous ImplantsThe Stern Metals Co., Inc. · 1994

All 4 as The Stern Metals Co., Inc. →