510(k) · Cleared
ClearedHHC, Score, Henry Schein Canister Handpiece
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Handpiece Headquarters, Inc. - Hpr, Inc. · EFB Handpiece, Air-Powered, Dental
Cleared on Sep 11, 2008 as substantially equivalent to K062947 (Peng Lim Enterprise Co., Ltd., 2006) after a 185-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Sep 11, 2008
- Review
- 185 days
- Class
- Class I
- Product code
- EFB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K935676 (1995). No later device cites it as a predicate yet.
- Root · 4 generations backK935676 Micro RSH High Speed HandpieceMicro Motors, Inc. · 1995
- 3 generations backK033213 Codent Dental Air-Powered Handpiece, Model HPSCodent Technical Industry Co., Ltd. · 2004
- 2 generations backK052822 Dental Air-Powered Handpiece, Models Tiger 100, 101, 200, 201 and 202Thunder Tiger Corp. · 2006
- 1 generation backK062947 High Speed Air Turbine Handpiece, Models Super-Air and Super-QD SeriesPeng Lim Enterprise Co., Ltd. · 2006
- This deviceK080682 HHC, Score, Henry Schein Canister HandpieceHandpiece Headquarters, Inc. - Hpr, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K935676 | Micro RSH High Speed Handpiece | Micro Motors, Inc. | 1995 | — |
| −3 | K033213 | Codent Dental Air-Powered Handpiece, Model HPS | Codent Technical Industry Co., Ltd. | 2004 | — |
| −2 | K052822 | Dental Air-Powered Handpiece, Models Tiger 100, 101, 200, 201 and 202 | Thunder Tiger Corp. | 2006 | — |
| −1 | K062947 | High Speed Air Turbine Handpiece, Models Super-Air and Super-QD Series | Peng Lim Enterprise Co., Ltd. | 2006 | — |
| 0 (this device) | K080682 | HHC, Score, Henry Schein Canister Handpiece | Handpiece Headquarters, Inc. - Hpr, Inc. | 2008 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EFB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new EFB device
- #1 K262144 DIAMED Handpiece;DIAMED Airmotor;DIAMED…score 13.3 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K062947 | High Speed Air Turbine Handpiece, Models Super-Air and Super-QD SeriesSummary page 1…SUPER-AIR: Standard, 400,000 rpm, push button chuck. Products of Peng Lim Enterprise Co., Ltd. (K062947) f- Description of the device: Th'le canister handpiece is a complete dental han… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K062947.
How does its category compare?
All EFB devicesEFB Handpiece, Air-Powered, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · EFB
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EFB
209in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EFB
No recall names EFB since 2007.
Adverse event reports per year · EFB
83in 2025
MAUDE reports naming product code EFB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 12 | 61 | 0 | 13 |
| 2008 | 7 | 97 | 0 | 19 |
| 2009 | 11 | 120 | 0 | 40 |
| 2010 | 8 | 116 | 0 | 78 |
| 2011 | 4 | 168 | 0 | 96 |
| 2012 | 8 | 130 | 0 | 97 |
| 2013 | 3 | 207 | 0 | 61 |
| 2014 | 7 | 200 | 0 | 73 |
| 2015 | 7 | 296 | 0 | 87 |
| 2016 | 3 | 205 | 0 | 122 |
| 2017 | 7 | 246 | 0 | 153 |
| 2018 | 3 | 210 | 0 | 81 |
| 2019 | 3 | 348 | 0 | 117 |
| 2020 | 5 | 259 | 0 | 94 |
| 2021 | 2 | — | 0 | 123 |
| 2022 | 5 | 430 | 0 | 157 |
| 2023 | 4 | 158 | 0 | 116 |
| 2024 | 5 | 209 | 0 | 104 |
| 2025 | 1 | — | 0 | 83 |
| 2026 | 4 | 252 | 0 | — |
What is it indicated for?
The Dental Handpiece is used by authorized persons in the practice of dentistry.
This Handpiece is intended for removing carious material, cavity preparations, finishing tooth preparations, reducing hard tooth structures, restorations and polishing teeth.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080682 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080682: HHC, Score, Henry Schein Canister Handpiece.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080682
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026