Data / Medical devices / United States / Handpiece Headquarters - HPR Inc.
Handpiece Headquarters - HPR Inc.: FDA-registered device maker in Placentia, CA, United States, 8 510(k) clearances
Handpiece Headquarters - HPR Inc. is registered with the FDA (registration 3007007357) in Placentia, CA, United States. It lists 6 device types. The FDA files 8 510(k) clearances under its listings, the newest dated December 20, 2024. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007007357
- Address
- 620 S. Placentia Ave., Placentia, CA, United States, 92870
- Owner or operator
- Handpiece Headquarters (10028763)
- Roles
- Manufacturer, Specification developer
- First device listed
- March 4, 2009
- Registered through
- 2026
- Brand names listed
- BASE290 LED Curing Light, Ball Bearing Latch Contra Angle 40K, Carina, ChoicePro, DHR, Deluxe Sectional Ball Bearing Latch Contra Angle 40K, Deluxe Sectional Friction Grip Contra Angle 20K, Deluxe Sectional Latch Contra Angle 20K and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Activator, Ultraviolet, For Polymerization | EBZ | 2 | Specification developer | accessdata.fda.gov |
| Controller, Foot, Handpiece And Cord | EBW | 1 | Specification developer | accessdata.fda.gov |
| Handpiece, Air-Powered, Dental | EFB | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Handpiece, Contra- And Right-Angle Attachment, Dental | EGS | 1 | Specification developer | accessdata.fda.gov |
| Handpiece, Direct Drive, Ac-Powered | EKX | 1 | Specification developer | accessdata.fda.gov |
| System, X-Ray, Extraoral Source, Digital | MUH | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 20, 2024 | K243911 | HPR Cordless Hygiene Handpiece | EKX | Substantially Equivalent | Handpiece Headquarters | accessdata.fda.gov |
| November 2, 2023 | K233518 | BASE290 LED Curing Light | EBZ | Substantially Equivalent | Handpiece Headquarters | accessdata.fda.gov |
| August 31, 2022 | K221955 | Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20 | MUH | Substantially Equivalent | Realcloud Imaging Inc. Dba Realcloud Imaging | accessdata.fda.gov |
| July 25, 2019 | K180845 | Maxima Electric System | EBW | Substantially Equivalent | Handpiece Headquarters - Hpr, Inc. | accessdata.fda.gov |
| February 17, 2015 | K143183 | Maxima XTEND Handpiece Maintenance System | EFB | Substantially Equivalent | Handpiece Headquarters | accessdata.fda.gov |
| October 23, 2014 | K141125 | U-TYPE CONTRA ANGLE, U-TYPE SECTIONAL CONTRA ANGLE | EGS | Substantially Equivalent | Handpiece Headquarters | accessdata.fda.gov |
| April 5, 2012 | K113674 | SPRAY & CLEAN HANDPIECE CLEANER& LUBRICANT MAXIMA HANDPIECE CLEANER & LUBRICANT EZCARE HANDPIECE CLEANER & LUBRICANT | EFB | Substantially Equivalent | Handpiece Headquarters, Inc. - Hpr, Inc. | accessdata.fda.gov |
| September 11, 2008 | K080682 | HHC, SCORE, HENRY SCHEIN CANISTER HANDPIECE | EFB | Substantially Equivalent | Handpiece Headquarters, Inc. - Hpr, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 4, 2018 | 81459 | Class II | Ongoing | Henry Schein CU 1000 Halogen Curing Light, Catalog. - Product Usage: Curing light for use in dentistry. The labeling did not provide specific details for intended use. Distributed by Henry Schein Inc., Melville, NY. | Tip of the curing light was too hot causing a heat sensation in the patients. | accessdata.fda.gov |
Compare with other makers
- All makers of Handpiece, Air-Powered, Dental
- All makers of Handpiece, Direct Drive, Ac-Powered
- All makers of Activator, Ultraviolet, For Polymerization
- All makers of Controller, Foot, Handpiece And Cord
- All makers of Handpiece, Contra- And Right-Angle Attachment, Dental
- All makers of System, X-Ray, Extraoral Source, Digital
Updated December 20, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.