510(k) · Cleared
ClearedLares Ultralite Prostyle High-Speed Dental Handpieces, Lares Euro Prostyle High-Speed Dental Handpieces, Lares Turbo+ PR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lares Research, Inc. · EFB Handpiece, Air-Powered, Dental
Cleared on Oct 28, 2014 as substantially equivalent to K780038 (Lares Manufacturing Co., Inc., 1978) and 2 other predicates after a 169-day review. Its family tree reaches back 3 generations to 1986.
- Decided
- Oct 28, 2014
- Review
- 169 days
- Class
- Class I
- Product code
- EFB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K863677 (1986). 8 ancestors in all, the oldest K780038 (1978). No later device cites it as a predicate yet.
- Root · 3 generations backK863677 Tradition High Speed HandpieceMidwest · 1986
- 2 generations backK965238 T1 Control High Speed Dental HandpieceSiemens AG · 1997
- 1 generation backK073478 Supertorque High-Speed Handpieces and Gentlepower Handpieces and…Sybron Dental Specialties, Inc. · 2008
- This deviceK141221 Lares Ultralite Prostyle High-Speed Dental Handpieces, Lares Euro…Lares Research, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K863677 | Tradition High Speed Handpiece | Midwest | 1986 | — |
| −2 | K965238 | T1 Control High Speed Dental Handpiece | Siemens AG | 1997 | — |
| −1 | K073478 | Supertorque High-Speed Handpieces and Gentlepower Handpieces and Attachements | Sybron Dental Specialties, Inc. | 2008 | — |
| 0 (this device) | K141221 | Lares Ultralite Prostyle High-Speed Dental Handpieces, Lares Euro Prostyle… | Lares Research, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2007 | 1 | 0 |
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? (3)
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 |
|---|---|---|---|
| * | K780038 | Dental HandpieceSummary page 4…EFB Predicate Devices 807.92(a)(3) Predicate Device #1: Lares Research 557 Turbo+, K780038 Predicate Device #2: Lares Research 757 Workhorse, K905541 P… | 1978 |
| * | K905541 | Lares 757 Workhorse Highspeed HandpieceSummary page 4…ice #1: Lares Research 557 Turbo+, K780038 Predicate Device #2: Lares Research 757 Workhorse, K905541 Predicate Device #3: Kavo GENTLEforce 6000B, K073478 Device Description… | 1991 |
| * | K073478 | Supertorque High-Speed Handpieces and Gentlepower Handpieces and AttachementsSummary page 4…Device #2: Lares Research 757 Workhorse, K905541 Predicate Device #3: Kavo GENTLEforce 6000B, K073478 Device Description 807.92(a)(4) The Lares Research 557 and 757 ProStyle model… | 2008 |
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 28 years and passes through 4 companies; a new generation was cleared every 10.5 years on median.
- 1 of the 8 ancestors has a recall of any class.
- 2 other devices also cite its predicate K780038.
How does its category compare?
All EFB devicesEFB Handpiece, Air-Powered, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Lares Research 557 and 757 ProStyle model product family of high-speed handpieces is intended to be used by licensed dental professionals to reduce hard tooth structure, carry out cavity preparations and perform restorative dentistry.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K141221 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141221: Lares Ultralite Prostyle High-Speed Dental Handpieces, Lares Euro Prostyle High-Speed Dental Handpieces, Lares Turbo+ PR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141221
Report an extraction error
Are you the manufacturer?
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