510(k) · Cleared
ClearedMastertorque Lux 8900 L
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kaltenbach & Voigt GmbH · EFB Handpiece, Air-Powered, Dental
Cleared on Sep 27, 2013 as substantially equivalent to K073478 (Sybron Dental Specialties, Inc., 2008) and 1 other predicate after a 207-day review. Its family tree reaches back 3 generations to 1999. 5 later devices descend from it.
- Decided
- Sep 27, 2013
- Review
- 207 days
- Class
- Class I
- Product code
- EFB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K992011 (1999). 9 ancestors in all, the oldest K863677 (1986). 5 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK992011 Synea-HS High Speed-HandpieceA-Dec, Inc. · 1999
- 2 generations backK043498 Twin Power Turbine High Speed Air Turbine Dental HandpieceJ. Morita USA, Inc. · 2005
- 1 generation backK061701 High Speed Air Turbine Handpieces, Par-4HEX/4HX Series (Twin Power…J. Morita USA, Inc. · 2006
- This deviceK130560 Mastertorque Lux 8900 LKaltenbach & Voigt GmbH · 2013
- Descendant · cites it directly · 3 of its ownK141886 MDK HandpiecesModern Korea Co., Ltd. · 2015
- Descendant · 2 generations on · 0 of its ownK262144 DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor HandpieceSETAGAYA SEIKI Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK251388 Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4…Foshan Topmed Dental Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK202786 Dental Low-speed Handpieces and AccessoriesMicrop Technology (Taiwan), Inc. · 2021
- Descendant · cites it directly · 0 of its ownK173943 Dental High-speed Handpiece and AccessoriesMicrop Technology (Taiwan), Inc. · 2018
Most influential descendants
Showing 5 of 5 · See all- K141886MDK HandpiecesModern Korea Co., Ltd. · 2015 · cites it directly3descendants
- K262144DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor HandpieceSETAGAYA SEIKI Co., Ltd. · 2026 · 2 generations on0descendants
- K251388Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES…Foshan Topmed Dental Co., Ltd. · 2026 · 2 generations on0descendants
- K202786Dental Low-speed Handpieces and AccessoriesMicrop Technology (Taiwan), Inc. · 2021 · 2 generations on0descendants
- K173943Dental High-speed Handpiece and AccessoriesMicrop Technology (Taiwan), Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K992011 | Synea-HS High Speed-Handpiece | A-Dec, Inc. | 1999 | — |
| −2 | K043498 | Twin Power Turbine High Speed Air Turbine Dental Handpiece | J. Morita USA, Inc. | 2005 | — |
| −1 | K061701 | High Speed Air Turbine Handpieces, Par-4HEX/4HX Series (Twin Power Turbine 4H) | J. Morita USA, Inc. | 2006 | — |
| 0 (this device) | K130560 | Mastertorque Lux 8900 L | Kaltenbach & Voigt GmbH | 2013 | — |
| +1 | K141886 | MDK Handpieces | Modern Korea Co., Ltd. | 2015 | — |
| +2 | K262144 | DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece | SETAGAYA SEIKI Co., Ltd. | 2026 | — |
| +2 | K251388 | Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS… | Foshan Topmed Dental Co., Ltd. | 2026 | — |
| +2 | K202786 | Dental Low-speed Handpieces and Accessories | Microp Technology (Taiwan), Inc. | 2021 | — |
| +1 | K173943 | Dental High-speed Handpiece and Accessories | Microp Technology (Taiwan), Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2026 | 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 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? (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 |
|---|---|---|---|
| * | K073478 | Supertorque High-Speed Handpieces and Gentlepower Handpieces and AttachementsSummary page 1…ification Name.- Dental handpiece and accessories, per 21 CFR § 872.4200 Devices for Which Substantial Equivalence is Claimed: "SUPERTORQUE HIGH-SPEED HANDPIECES (K073478) "HIGH SPEED AIR TURBINE HANDRIECES, PAR-4HEX/4HX SERIES, TWIN Power (K061701) Device Description: The AlASTERtorqtie LUX… | 2008 |
| * | K061701 | High Speed Air Turbine Handpieces, Par-4HEX/4HX Series (Twin Power Turbine 4H)Summary page 1…for Which Substantial Equivalence is Claimed: "SUPERTORQUE HIGH-SPEED HANDPIECES (K073478) "HIGH SPEED AIR TURBINE HANDRIECES, PAR-4HEX/4HX SERIES, TWIN Power (K061701) Device Description: The AlASTERtorqtie LUX 8900 Lair-driven handpieces are dental handpieces for the use by a trained profes… | 2006 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 14 years and passes through 3 companies; a new generation was cleared every 5.4 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K141886 (Modern Korea Co., Ltd., 2015) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K073478.
How does its category compare?
All EFB devicesEFB Handpiece, Air-Powered, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 MASTERtorque LUX 8900 L is Intended for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, removal of filings, processing and 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/K130560 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130560: Mastertorque Lux 8900 L.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130560
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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