510(k) Report

FDA applicant

Brasseler USA I, L.P.

Savannah, GA4 decisions1995–20032 recalls

FDA records 4 decisions for Brasseler USA I, L.P. (Savannah, GA) from 1995 to 2003: 4 510(k) clearances. Most are in product codes DZL (Screw, Fixation, Intraosseous) and HBE (Drills, Burrs, Trephines & Accessories…). 2 recalls are 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 Brasseler USA I, L.P.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Brasseler USA I, L.P. since 2007.

Recalls per year

1in 2022

2019: 12022: 1
2007high 1 (2019) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Brasseler USA I, L.P. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DZLScrew, Fixation, Intraosseous1decision
  • HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)1decision
  • FRGWrap, Sterilization1decision
  • JDWPin, Fixation, Threaded1decision

What has FDA decided for it lately?

  • K030172Small High Speed Motor Drill SystemBrasseler USA I, L.P. · 2003
  • K983223Dental Sterlization Tray/CassetteBrasseler USA I, L.P. · 1999
  • K9551402.0 X 6MM ScrewBrasseler USA I, L.P. · 1996
  • K945670Kirschner (K-Wire), Steinman PinsBrasseler USA I, L.P. · 19952 recalls

All 4 as Brasseler USA I, L.P. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K945670Brasseler USA, K-WIRE, Double Trocar Smooth, REF KM172-26-35SJan 28, 2022Class II
  • K945670Brasseler USA KM169-39-76 Steinmann Pin Single Diamond Smooth, Diameter 2.8 mm, Length…Dec 11, 2019Class II