510(k) Report

FDA applicant

Sterngold/Implamed

Attleboro, MA16 decisions1992–19990 recalls

FDA records 16 decisions for Sterngold/Implamed (Attleboro, MA) from 1992 to 1999: 16 510(k) clearances. Most are in product codes EJT (Alloy, Gold-Based Noble Metal) and DZE (Implant, Endosseous, Root-Form). Its devices cite 24 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 Sterngold/Implamed’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sterngold/Implamed since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Sterngold/Implamed”

FDA records each applicant name separately; these may or may not be the same firm.