510(k) · Cleared
ClearedSupertorque High-Speed Handpieces and Gentlepower Handpieces and Attachements
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sybron Dental Specialties, Inc. · EFB Handpiece, Air-Powered, Dental
Cleared on Sep 3, 2008 as substantially equivalent to K965238 (Siemens AG, 1997) and 2 other predicates after a 267-day review. Its family tree reaches back 2 generations to 1986. 23 later devices descend from it.
- Decided
- Sep 3, 2008
- Review
- 267 days
- Class
- Class I
- Product code
- EFB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K863677 (1986). 5 ancestors in all. 23 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK863677 Tradition High Speed HandpieceMidwest · 1986
- 1 generation backK965238 T1 Control High Speed Dental HandpieceSiemens AG · 1997
- This deviceK073478 Supertorque High-Speed Handpieces and Gentlepower Handpieces and…Sybron Dental Specialties, Inc. · 2008
- Descendant · cites it directly · 13 of its ownK102517 Tiger 500 Series High Speed Handpieces and AttachmentsThunder Tiger Corp. · 2011
- Descendant · 2 generations on · 8 of its ownK152146 High Speed Handpieces and AccessoriesCodent Technical Industry Co., Ltd. · 2015
- Descendant · cites it directly · 5 of its ownK130560 Mastertorque Lux 8900 LKaltenbach & Voigt GmbH · 2013
- Descendant · 3 generations on · 4 of its ownK170229 Dental High-speed Turbine HandpieceGuangdong Jinme Medical Technology Co., Ltd. · 2017
- Descendant · 2 generations on · 3 of its ownK141886 MDK HandpiecesModern Korea Co., Ltd. · 2015
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K102517Tiger 500 Series High Speed Handpieces and AttachmentsThunder Tiger Corp. · 2011 · cites it directly13descendants
- K152146High Speed Handpieces and AccessoriesCodent Technical Industry Co., Ltd. · 2015 · 2 generations on8descendants
- K130560Mastertorque Lux 8900 LKaltenbach & Voigt GmbH · 2013 · cites it directly5descendants
- K170229Dental High-speed Turbine HandpieceGuangdong Jinme Medical Technology Co., Ltd. · 2017 · 3 generations on4descendants
- K141886MDK HandpiecesModern Korea Co., Ltd. · 2015 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K863677 | Tradition High Speed Handpiece | Midwest | 1986 | — |
| −1 | K965238 | T1 Control High Speed Dental Handpiece | Siemens AG | 1997 | — |
| 0 (this device) | K073478 | Supertorque High-Speed Handpieces and Gentlepower Handpieces and Attachements | Sybron Dental Specialties, Inc. | 2008 | — |
| +1 | K102517 | Tiger 500 Series High Speed Handpieces and Attachments | Thunder Tiger Corp. | 2011 | — |
| +2 | K152146 | High Speed Handpieces and Accessories | Codent Technical Industry Co., Ltd. | 2015 | — |
| +1 | K130560 | Mastertorque Lux 8900 L | Kaltenbach & Voigt GmbH | 2013 | — |
| +3 | K170229 | Dental High-speed Turbine Handpiece | Guangdong Jinme Medical Technology Co., Ltd. | 2017 | — |
| +2 | K141886 | MDK Handpieces | Modern Korea Co., Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K965238 | T1 Control High Speed Dental HandpieceSummary page 1…Air-Powered, Dental, per 21 CFR § 872.4200 Devices for Which Substantial Equivalence is Claimed: · Siemens AG (now Sirona), Ti Control High Speed Dental Handpieces (K965238) · DEN-TAL-EZ, Inc., STAR DENTAL 430 Series High Speed Handpieces (K960719). Device Description: The SUPERtorque High-Speed Ha… | 1997 |
| * | K960719 | Star Dental 430 Series High Speed HandpieceSummary page 1…uivalence is Claimed: · Siemens AG (now Sirona), Ti Control High Speed Dental Handpieces (K965238) · DEN-TAL-EZ, Inc., STAR DENTAL 430 Series High Speed Handpieces (K960719). Device Description: The SUPERtorque High-Speed Handpieces are dental handpieces for use by a trained professional in general d… | 1996 |
| * | K070663 | A-Dec/W&H Synea Air-Driven Highspeed Handpiece, Model TA-98, TA-97, a-Dec/W&H Synea… | 2007 |
What descends from it? (23)
See all 235 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102517 | Tiger 500 Series High Speed Handpieces and Attachments | 2011 | 13 |
| K130560 | Mastertorque Lux 8900 L | 2013 | 5 |
| K220874 | Smooth Drive contra angle and straight handpieces | 2022 | 0 |
| K141221 | Lares Ultralite Prostyle High-Speed Dental Handpieces, Lares Euro Prostyle High-Speed… | 2014 | 0 |
| K093341 | Century Model 105C | 2010 | 0 |
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 22 years and passes through 3 companies; a new generation was cleared every 11.5 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K102517 (Thunder Tiger Corp., 2011) has gone furthest, with 13 descendants of its own.
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 SUPERtorque High-Speed Handpieces are intended for the removal of carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations, restorations, and for polishing teeth. They are designed for use by a trained professional in the field of general dentistry.
The GENTLEpower Handpieces and Attachments are intended for the removal of carious material, excess filling material, reducing hard tooth structure, cavity and crown preparation, root canal preparation, finishing tooth preparations, restorations and for polishing teeth. They are designed for use by a trained professional in the field of general dentistry.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073478 · printed Nov 5, 2026
Cite this page
510(k) Report. “K073478: Supertorque High-Speed Handpieces and Gentlepower Handpieces and Attachements.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K073478
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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