Handpiece Headquarters: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Handpiece Headquarters” (first 2009, latest 2024), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 74 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 175 |
| 2015 | 1 | 104 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 1 |
| 2024 | 1 | 1 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Handpiece Headquarters took a median 1 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 234 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EFB | Handpiece, Air-Powered, Dental | 2 | 2 |
| EGS | Handpiece, Contra- And Right-Angle Attachment, Dental | 2 | 2 |
| EBZ | Activator, Ultraviolet, For Polymerization | 1 | 1 |
| EKX | Handpiece, Direct Drive, Ac-Powered | 1 | 1 |
Review panels
- Dental (6)
Most recent Handpiece Headquarters 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243911 | HPR Cordless Hygiene Handpiece | EKX | 2024-12-20 | 1 |
| K233518 | BASE290 LED Curing Light | EBZ | 2023-11-02 | 1 |
| K143183 | Maxima XTEND Handpiece Maintenance System | EFB | 2015-02-17 | 104 |
| K141125 | U-TYPE CONTRA ANGLE, U-TYPE SECTIONAL CONTRA ANGLE | EGS | 2014-10-23 | 175 |
| K100389 | HHC PUSH-BUTTON REPLACEMENT TURBINE FOR MIDWEST TRADITION HANDPIECE MODEL MW TURBINE REPLACEMENT | EFB | 2010-08-12 | 177 |
| K092053 | MAXIMA-M STRAIGHT ATTACHMENT, MAXIMA-M CONTRA ANGLE SHEATH | EGS | 2009-08-20 | 44 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2018-04-04.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Handpiece Headquarters, Inc. - Hpr, Inc. (2 510(k)s)
- Handpiece Club, LLC (1 510(k)s)
- Handpiece Headquarters - Hpr, Inc. (1 510(k)s)
- Handpiece Unlimited (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Handpiece Headquarters?
FDA lists 6 510(k) clearances under the applicant name “Handpiece Headquarters” (first 2009, latest 2024), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Handpiece Headquarters?
The median time from FDA receipt to decision across 510(k)s cleared under the name Handpiece Headquarters is 74 days.
Which FDA product codes appear under Handpiece Headquarters?
The most frequent FDA product codes under this applicant name are EFB (Handpiece, Air-Powered, Dental, 2); EGS (Handpiece, Contra- And Right-Angle Attachment, Dental, 2); EBZ (Activator, Ultraviolet, For Polymerization, 1).
Next steps
- See all 6 Handpiece Headquarters clearances with predicates and recalls
- Run predicate analysis for product code EFB, Handpiece Headquarters's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.