510(k) · Cleared
ClearedMASTERmatic LUX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kaltenbach & Voigt GmbH · EFA Handpiece, Belt And/Or Gear Driven, Dental
Cleared on Apr 9, 2015 as substantially equivalent to K070663 (A-Dec, Inc., 2007) after a 126-day review. Its family tree reaches back 1 generation to 2007. 4 later devices descend from it.
- Decided
- Apr 9, 2015
- Review
- 126 days
- Class
- Class I
- Product code
- EFA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K070663 (2007). 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK070663 A-Dec/W&H Synea Air-Driven Highspeed Handpiece, Model TA-98, TA-97…A-Dec, Inc. · 2007
- This deviceK143465 MASTERmatic LUXKaltenbach & Voigt GmbH · 2015
- Descendant · cites it directly · 3 of its ownK163239 SMARTmaticKaltenbach & Voigt GmbH · 2017
- Descendant · 2 generations on · 2 of its ownK192809 Dental HandpieceMicro-Nx Co., Ltd. · 2020
- Descendant · 3 generations on · 1 of its ownK220577 Dental Handpiece, Model CA160, CA160L, and CA500LMicro-Nx Co., Ltd. · 2022
- Descendant · 4 generations on · 0 of its ownK232810 Dental Handpiece, Wireless Endodontic Handpiece, endoitMicro-Nx Co., Ltd. · 2023
Most influential descendants
Showing 4 of 4 · See all- K163239SMARTmaticKaltenbach & Voigt GmbH · 2017 · cites it directly3descendants
- K192809Dental HandpieceMicro-Nx Co., Ltd. · 2020 · 2 generations on2descendants
- K220577Dental Handpiece, Model CA160, CA160L, and CA500LMicro-Nx Co., Ltd. · 2022 · 3 generations on1descendant
- K232810Dental Handpiece, Wireless Endodontic Handpiece, endoitMicro-Nx Co., Ltd. · 2023 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K070663 | A-Dec/W&H Synea Air-Driven Highspeed Handpiece, Model TA-98, TA-97, a-Dec/W&H… | A-Dec, Inc. | 2007 | — |
| 0 (this device) | K143465 | MASTERmatic LUX | Kaltenbach & Voigt GmbH | 2015 | — |
| +1 | K163239 | SMARTmatic | Kaltenbach & Voigt GmbH | 2017 | — |
| +2 | K192809 | Dental Handpiece | Micro-Nx Co., Ltd. | 2020 | — |
| +3 | K220577 | Dental Handpiece, Model CA160, CA160L, and CA500L | Micro-Nx Co., Ltd. | 2022 | — |
| +4 | K232810 | Dental Handpiece, Wireless Endodontic Handpiece, endoit | Micro-Nx Co., Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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 EFA? 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 EFA device
- #1 K192809 Dental Handpiecescore 3.5 · 3 generations · no Class I recall
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K070663 | A-Dec/W&H Synea Air-Driven Highspeed Handpiece, Model TA-98, TA-97, a-Dec/W&H Synea…Summary page 4…ec 1 W&H Synea Air-Driven Highspeed Handpieces, Models TA-98, TA-97 1 A-dec 1 W&H Synea Handpiece Attachment, Models WA-99LT, WA-86LT, WA-66LT, WA-56LT, HA-43LT (K070663) marketed by W & H DENTALWERK BUERMOOS GMBH. Device Description: The MASTERmatic LUX electrical-driven handpieces • MASTERm… | 2007 |
| † | K071288 | Modification to Kavo Quattrocare | 2007 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K163239 | SMARTmatic | 2017 | 3 |
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?
How does its category compare?
All EFA devicesEFA Handpiece, Belt And/Or Gear Driven, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · EFA
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · EFA
78in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EFA
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EFA
4in 2025
MAUDE reports naming product code EFA, 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 | 1 |
| 2008 | 0 | — | 0 | 17 |
| 2009 | 4 | 78 | 0 | 0 |
| 2010 | 2 | — | 1 | 1 |
| 2011 | 0 | — | 0 | 4 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 97 |
| 2019 | 0 | — | 0 | 59 |
| 2020 | 1 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 4 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The MASTERmatic LUX handpieces are intended for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, 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/K143465 · printed Nov 5, 2026
Cite this page
510(k) Report. “K143465: MASTERmatic LUX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K143465
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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