510(k) · Cleared
ClearedSmooth Drive contra angle and straight handpieces
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lares Research · EGS Handpiece, Contra- And Right-Angle Attachment, Dental
Cleared on Nov 7, 2022 as substantially equivalent to K983183 (Bien Air USA, Inc., 1998) and 1 other predicate after a 227-day review. Its family tree reaches back 3 generations to 1986.
- Decided
- Nov 7, 2022
- Review
- 227 days
- Class
- Class I
- Product code
- EGS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K863677 (1986). 7 ancestors in all. 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 deviceK220874 Smooth Drive contra angle and straight handpiecesLares Research · 2022
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) | K220874 | Smooth Drive contra angle and straight handpieces | Lares Research | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 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 EGS? 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 EGS device
- #1 K251869 Disposable Prophy Angle (3399-60, 3399-090…score 10.0 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K983183 | Gyro Long-Life,Black Pearl Eco, Ondine &Croma, Prestige, Bora, Aquilon, MC2,MC3, Basch…Summary page 4…EGS Predicate Devices 807.92(a)(3) Predicate Device (primary): Bien Air Dental - CA Classic 1:5 L K983183 Predicate Device (secondary, for biocompatibility material comparison): KaVo 25 LPA 1:5 c… | 1998 |
| * | K073478 | Supertorque High-Speed Handpieces and Gentlepower Handpieces and AttachementsSummary page 4…l - CA Classic 1:5 L K983183 Predicate Device (secondary, for biocompatibility material comparison): KaVo 25 LPA 1:5 contra angle K073478 Device Description 807.92(a)(4) The Lares Research Smoothdrive 1:5 contra an… | 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 36 years and passes through 4 companies; a new generation was cleared every 11.5 years on median.
- 1 of the 7 ancestors has a recall of any class.
- 3 other devices also cite its predicate K983183.
How does its category compare?
All EGS devicesEGS Handpiece, Contra- And Right-Angle Attachment, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · EGS
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EGS
189in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EGS
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EGS
82in 2025
MAUDE reports naming product code EGS, 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 | 1 | — | 0 | 2 |
| 2008 | 0 | — | 0 | 14 |
| 2009 | 1 | — | 0 | 45 |
| 2010 | 2 | — | 0 | 74 |
| 2011 | 3 | 104 | 0 | 2 |
| 2012 | 3 | 288 | 0 | 3 |
| 2013 | 1 | — | 0 | 2 |
| 2014 | 2 | — | 0 | 38 |
| 2015 | 3 | 245 | 0 | 166 |
| 2016 | 0 | — | 0 | 299 |
| 2017 | 2 | — | 0 | 316 |
| 2018 | 1 | — | 0 | 230 |
| 2019 | 3 | 276 | 0 | 219 |
| 2020 | 1 | — | 0 | 191 |
| 2021 | 1 | — | 0 | 294 |
| 2022 | 4 | 189 | 0 | 279 |
| 2023 | 1 | — | 1 | 115 |
| 2024 | 1 | — | 0 | 81 |
| 2025 | 2 | — | 0 | 82 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Products intended for professional use
only. Used in general dentistry for restoration procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220874 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220874: Smooth Drive contra angle and straight handpieces.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220874
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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