Manufacturer registered with FDA
Handpiece Headquarters
Placentia, CA, United States. Lists 6 dental device types with FDA across 1 registered establishment, and holds 7 510(k) clearances as applicant.
- Device types listed
- 6
- Brands and models
- 23
- 510(k) clearances
- 72009–2024
- Markets registered in
- 330 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2000–2026
Registered in 3 markets
Where regulators' registries name Handpiece Headquarters as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Handpiece Headquarters | 7 clearances | 2009–2024 | Below |
| Canada | Health Canada | Registration holder | HANDPIECE HEADQUARTERS - HPR INC. | 27 | 2008–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | HANDPIECE HEADQUARTERS-HPR INCHANDPIECE HEADQUARTERS | 3 | 2012–2015 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Handpiece Headquarters currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental Air-Powered HandpieceEFB · Class 1 | Dental handpieces | Maker | Dental Handpiece Cleaner and LubricantDHRHHCMedidenta Air KingProphy MagicQualityPlusScoreTTCARE 100+TTlube spray | 2009 |
| Handpiece and Cord Foot ControllerEBW · Class 1 | — | Maker | ChoiceProMedilectricThor 700+ | 2019 |
| Ultraviolet Activator for PolymerizationEBZ · Class 2 | Curing lights | Maker | BASE290 LED Curing LightMaxima Advanced 3000 LED Curing Light | 2023 |
| Dental Contra- and Right-Angle Attachment HandpieceEGS · Class 1 | Dental handpieces | Maker | Ball Bearing Latch Contra Angle 40KDeluxe Sectional Ball Bearing Latch Contra Angle 40KDeluxe Sectional Friction Grip Contra Angle 20KDeluxe Sectional Latch Contra Angle 20KFriction Grip Contra Angle 20KLatch Contra Angle 20K | 2016 |
| Ac-Powered Direct Drive HandpieceEKX · Class 1 | Dental handpieces | Maker | HPR Cordless Hygiene Handpiece | 2024 |
| Digital Extraoral Source X-Ray SystemMUH · Class 2 | Dental X-ray units | Maker | CarinaGEM | 2024 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Handpiece Headquarters as the applicant, including filings under its other names.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 20 Dec 2024 | K243911 | HPR Cordless Hygiene Handpiece | EKX Ac-Powered Direct Drive Handpiece |
| 2 Nov 2023 | K233518 | BASE290 LED Curing Light | EBZ Ultraviolet Activator for Polymerization |
| 25 Jul 2019 | K180845 | Maxima Electric System | EBW Handpiece and Cord Foot Controller |
| 17 Feb 2015 | K143183 | Maxima XTEND Handpiece Maintenance System | EFB Dental Air-Powered Handpiece |
| 23 Oct 2014 | K141125 | U-TYPE CONTRA ANGLE, U-TYPE SECTIONAL CONTRA ANGLE | EGS Dental Contra- and Right-Angle Attachment Handpiece |
| 12 Aug 2010 | K100389 | HHC PUSH-BUTTON REPLACEMENT TURBINE FOR MIDWEST TRADITION HANDPIECE MODEL MW TURBINE REPLACEMENT | EFB Dental Air-Powered Handpiece |
| 20 Aug 2009 | K092053 | MAXIMA-M STRAIGHT ATTACHMENT, MAXIMA-M CONTRA ANGLE SHEATH | EGS Dental Contra- and Right-Angle Attachment Handpiece |
Also lists devices cleared under other names
Handpiece Headquarters lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Handpiece Headquarters, Inc. - Hpr, Inc. (2), Realcloud Imaging Inc. Dba Realcloud Imaging (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 31 Aug 2022 | K221955 | Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20 | Realcloud Imaging Inc. Dba Realcloud Imaging | MUH Digital Extraoral Source X-Ray System |
| 5 Apr 2012 | K113674 | SPRAY & CLEAN HANDPIECE CLEANER& LUBRICANT MAXIMA HANDPIECE CLEANER & LUBRICANT EZCARE HANDPIECE CLEANER & LUBRICANT | Handpiece Headquarters, Inc. - Hpr, Inc. | EFB Dental Air-Powered Handpiece |
| 11 Sep 2008 | K080682 | HHC, SCORE, HENRY SCHEIN CANISTER HANDPIECE | Handpiece Headquarters, Inc. - Hpr, Inc. | EFB Dental Air-Powered Handpiece |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Handpiece Headquarters - HPR Inc.FDA reg. 3007007357 | Placentia, CA, United States | Manufacturer, Specification developer |
Other names on FDA records
Handpiece Headquarters-Hpr Inc.
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10028763). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.