510(k) Report

FDA applicant

Biomedical Composites, Ltd.

Carpinteria, CA2 decisions1987–19920 recalls

FDA records 2 decisions for Biomedical Composites, Ltd. (Carpinteria, CA) from 1987 to 1992: 2 510(k) clearances. Most are in product codes EMI (File, Bone, Surgical) and EBI (Resin, Denture, Relining, Repairing, Rebasing). 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 Biomedical Composites, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Biomedical Composites, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Biomedical Composites, Ltd.’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?

  • EMIFile, Bone, Surgical1decision
  • EBIResin, Denture, Relining, Repairing, Rebasing1decision

What has FDA decided for it lately?

  • K914035Mini-MillBiomedical Composites, Ltd. · 1992
  • K871312FibreflexBiomedical Composites, Ltd. · 1987

All 2 as Biomedical Composites, Ltd. →