FDA applicant

D.B.I. America Corp.

Tampa, FL2 decisions1998–20050 recalls

FDA records 2 decisions for D.B.I. America Corp. (Tampa, FL) from 1998 to 2005: 2 510(k) clearances. Most are in product codes EFB (Handpiece, Air-Powered, Dental) and ELC (Scaler, Ultrasonic). 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 D.B.I. America Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for D.B.I. America Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — D.B.I. America Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like D.B.I. America Corp.’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

D.B.I. America Corp.

Which product codes does it file in?

What has FDA decided for it lately?