Handpiece Headquarters
Medical device manufacturer in Placentia, CA.
6510(k) clearances
0PMA approvals
1recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K243911 | HPR Cordless Hygiene HandpieceEKX · Traditional | 12/20/2024SE |
| K233518 | BASE290 LED Curing LightEBZ · Traditional | 11/02/2023SE |
| K143183 | Maxima XTEND Handpiece Maintenance SystemEFB · Traditional | 02/17/2015SE |
| K141125 | U-Type Contra Angle, U-Type Sectional Contra AngleEGS · Traditional | 10/23/2014SE |
| K100389 | HHC Push-Button Replacement Turbine for Midwest Tradition Handpiece Model MW Turbine…EFB · Traditional | 08/12/2010SE |
| K092053 | Maxima-M Straight Attachment, Maxima-M Contra Angle SheathEGS · Traditional | 08/20/2009SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0797-2019 Class II | Henry Schein CU 1000 Halogen Curing Light, Catalog 900-4542. - Product Usage: Curing…Tip of the curing light was too hot causing a heat sensation in the patients. | 04/04/2018Open, Classified |