Handpiece Headquarters
Country not established FDA establishment FEI 3007007357
- Devices
- 9
- Registrations
- FDA
- FDA recalls
- 1
What Handpiece Headquarters makes
Handpiece Headquarters manufactures dental handpiece accessories and maintenance systems, including turbine replacements for specific handpiece models, cordless hygiene handpieces, contra angle attachments, and sheaths for straight and sectional handpieces. Their portfolio also includes a handpiece maintenance system designed for cleaning and servicing dental instruments.
The company’s products are classified as Class I medical devices and are listed under the FDA’s 510(k) pathway. These devices are intended for use in dental procedures and are regulated under U.S. jurisdiction. The manufacturer is based in the United States.
Catalogue
BASE290 LED Curing Light Ref K233518
510(k) 510(k)Hhc Push-Button Replacement Turbine For Midwest Tradition Handpiece Model Mw Turbine Replacement Ref K100389
510(k) 510(k)HPR Cordless Hygiene Handpiece Ref K243911
510(k) 510(k)- 510(k) 510(k)
- 510(k) 510(k)
Maxima XTEND Handpiece Maintenance System Ref K143183
510(k) 510(k)Maxima Electric System Ref K180845
510(k) 510(k)- 510(k) 510(k)
Hhc, Score, Henry Schein Canister Handpiece Ref K080682
CE MDR 510(k) 510(k)
Company details
- FDA FEI number
- 3007007357
- Address
- 620 S. Placentia Ave., Placentia, CA, 92870
FDA recalls
FDA recall records list 1 recall initiated by Handpiece Headquarters, initiated on 2018-04-04. By recorded status: 1 ongoing. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 1
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2018
- 4 Apr 2018 Z-0797-2019 Class II Open since 2018 Tip of the curing light was too hot causing a heat sensation in the patients.
Full distribution text
- 4 Apr 2018 Z-0797-2019 Class II Open since 2018 Tip of the curing light was too hot causing a heat sensation in the patients.
Frequently asked questions
How many devices does Handpiece Headquarters have in the registry?
The registry currently lists 9 devices for Handpiece Headquarters. Devices recorded under merged duplicate company entries are counted once.
Which registries list Handpiece Headquarters's devices?
Among its 9 most recently registered devices, Handpiece Headquarters has devices listed in FDA 510(k) (9 devices).
What risk classes do Handpiece Headquarters's devices fall under?
Among its 9 most recently registered devices, the classes recorded for Handpiece Headquarters's devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Handpiece Headquarters?
FDA recall records list 1 recall initiated by Handpiece Headquarters, the most recent initiated on 2018-04-04. 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 Handpiece Headquarters in the registry?
The most recently registered devices listed for Handpiece Headquarters include BASE290 LED Curing Light, HHC PUSH-BUTTON REPLACEMENT TURBINE FOR MIDWEST TRADITION HANDPIECE MODEL MW TURBINE REPLACEMENT, HPR Cordless Hygiene Handpiece and U-TYPE CONTRA ANGLE, U-TYPE SECTIONAL CONTRA ANGLE.