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Brasseler USA I, L.P.

United StatesFDA 510(k) applicant, unverified

Devices
4
FDA recalls
31 ongoing

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Brasseler USA I, L.P. makes

Brasseler USA I, L.P. manufactures dental motorized drill systems designed for high-speed precision procedures, orthopedic fixation hardware including Kirschner wires and Steinmann pins, and sterilization trays and cassettes for dental instruments. Their product line also includes small titanium screws, such as the 2.0 x 6mm variant, for orthopedic or dental applications.

These devices are classified under Class II by the FDA and are supported by 510(k) clearances. The company’s products are listed in the U.S. regulatory database under the FDA’s 510(k) pathway. Brasseler USA I, L.P. operates from the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue4

Newest first, rows 1-4 of 4

FDA recalls3

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 3 recalls initiated by Brasseler USA I, L.P., the earliest on 2019-10-18 and the most recent on 2024-01-11. By recorded status: 1 ongoing and 2 terminated. The reasons filed fall into these groups: labeling or instructions for use, packaging and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

  • 2017 0
  • 2018 0
  • 2019 2
  • 2020 0
  • 2021 0
  • 2022 0
  • 2023 0
  • 2024 1
  • 2025 0
  • 2026 0

  • 2024

    • 11 Jan 2024 Z-1008-2024 Class II Ongoing The device has a grip detail (right angle latch) out of specification causing the bur to not adequately latch in the handpiece. Distribution: Worldwide - US Nationwide distribution in the states of AL, CA, CO, DC, IL, NY, OH, OR, PA, TN, TX, and WA. The country…
      Full distribution text Worldwide - US Nationwide distribution in the states of AL, CA, CO, DC, IL, NY, OH, OR, PA, TN, TX, and WA. The country of Canada.

  • 2019

    • 11 Dec 2019 Z-0884-2020 Class II Terminated 103 packaged and labeled tubes (103 product tubes with 6 pins per tube) of KM168-39-76 Single Diamond Smooth Steinmann Pins were labeled with the incorrect product labels. The tubes were incorrectly labeled as KM169-39-76 Single Diamond Threaded Steinmann Pins. Distribution: US: AZ, AR, FL Submission number: K945670
    • 18 Oct 2019 Z-0591-2020 Class II Terminated One lot of 3.5 mm twist drills were incorrectly laser etched as 2.5 mm the shaft of the device. Distribution: US Nationwide distribution. Submission number: K872475

Frequently asked questions

How many devices does Brasseler USA I, L.P. have in the registry?

The registry currently lists 4 devices for Brasseler USA I, L.P.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Brasseler USA I, L.P.'s devices?

Among its 4 most recently registered devices, Brasseler USA I, L.P. has devices listed in FDA 510(k) (4 devices).

What risk classes do Brasseler USA I, L.P.'s devices fall under?

Among its 4 most recently registered devices, the classes recorded for Brasseler USA I, L.P.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Brasseler USA I, L.P.?

FDA recall records list 3 recalls initiated by Brasseler USA I, L.P., the most recent initiated on 2024-01-11. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Brasseler USA I, L.P. in the registry?

The most recently registered devices listed for Brasseler USA I, L.P. include SMALL HIGH SPEED MOTOR DRILL SYSTEM, KIRSCHNER (K-WIRE), STEINMAN PINS, DENTAL STERLIZATION TRAY/CASSETTE and 2.0 X 6MM SCREW.

Generated automatically from registry data and not verified by a human reviewer.