510(k) · Cleared
ClearedTorqtech
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
J. Morita USA, Inc. · EGS Handpiece, Contra- And Right-Angle Attachment, Dental
Cleared on Jan 20, 2012 as substantially equivalent to K080677 (Kaltenbach & Voigt GmbH & Co., 2008) and 3 other predicates after a 396-day review. Its family tree reaches back 4 generations to 1997.
- Decided
- Jan 20, 2012
- Review
- 396 days
- Class
- Class I
- Product code
- EGS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K964860 (1997). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK964860 Mark 20 and Mark 25 Hand Engine ControllerBell Intl., Inc. · 1997
- 3 generations backK031584 Sirotorque LSirona Dental Systems GmbH · 2003
- 2 generations backK042759 Optima MXBien-Air SA Switzerland · 2004
- 1 generation backK080677 Comfortronic 4894 and Comfortdrive 200XDA HandpieceKaltenbach & Voigt GmbH & Co. · 2008
- This deviceK103697 TorqtechJ. Morita USA, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K964860 | Mark 20 and Mark 25 Hand Engine Controller | Bell Intl., Inc. | 1997 | — |
| −3 | K031584 | Sirotorque L | Sirona Dental Systems GmbH | 2003 | — |
| −2 | K042759 | Optima MX | Bien-Air SA Switzerland | 2004 | — |
| −1 | K080677 | Comfortronic 4894 and Comfortdrive 200XDA Handpiece | Kaltenbach & Voigt GmbH & Co. | 2008 | — |
| 0 (this device) | K103697 | Torqtech | J. Morita USA, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | K080677 | Comfortronic 4894 and Comfortdrive 200XDA HandpieceSummary page 3…Technological Characteristics of Handpiece Comparison result K080677 K061701 Indication for use - Similar Target population… | 2008 |
| * | K061701 | High Speed Air Turbine Handpieces, Par-4HEX/4HX Series (Twin Power Turbine 4H)Summary page 3…echnological Characteristics of Handpiece Comparison result K080677 K061701 Indication for use - Similar Target population… | 2006 |
| * | K070074 | Lubrina, Model Him-1Summary page 2…(K#061701) for purposes of biocompatibility of materials (3) J. Morita Manufacturing Corp.'s own "AR Spray" (included as part of KH/070074) and KAyO "KavoQuattrocare" spray (K#012308) for purposes of the LS Spray that is included with the TORQTECH device.… | 2007 |
| * | K012308 | Kavo QuattrocareSummary page 2…ompatibility of materials (3) J. Morita Manufacturing Corp.'s own "AR Spray" (included as part of KH/070074) and KAyO "KavoQuattrocare" spray (K#012308) for purposes of the LS Spray that is included with the TORQTECH device. Two charts identifying the specific ch… | 2002 |
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 15 years and passes through 5 companies; a new generation was cleared every 3.6 years on median.
- 1 of the 11 ancestors has a recall of any class.
- 1 other device also cites its predicate K080677.
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. 2012, 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?
TORQTECH transmits rotation of the motor to dental burrs and reamers which cut or grind teeth or dentures with the same or transformed rotation
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103697 · printed Nov 5, 2026
Cite this page
510(k) Report. “K103697: Torqtech.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K103697
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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