510(k) · Cleared
ClearedSMARTmatic
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 Mar 17, 2017 as substantially equivalent to K143465 (Kaltenbach & Voigt GmbH, 2015) after a 119-day review. Its family tree reaches back 2 generations to 2007. 3 later devices descend from it.
- Decided
- Mar 17, 2017
- Review
- 119 days
- Class
- Class I
- Product code
- EFA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K070663 (2007). 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK070663 A-Dec/W&H Synea Air-Driven Highspeed Handpiece, Model TA-98, TA-97…A-Dec, Inc. · 2007
- 1 generation backK143465 MASTERmatic LUXKaltenbach & Voigt GmbH · 2015
- This deviceK163239 SMARTmaticKaltenbach & Voigt GmbH · 2017
- Descendant · cites it directly · 2 of its ownK192809 Dental HandpieceMicro-Nx Co., Ltd. · 2020
- Descendant · 2 generations on · 1 of its ownK220577 Dental Handpiece, Model CA160, CA160L, and CA500LMicro-Nx Co., Ltd. · 2022
- Descendant · 3 generations on · 0 of its ownK232810 Dental Handpiece, Wireless Endodontic Handpiece, endoitMicro-Nx Co., Ltd. · 2023
Most influential descendants
Showing 3 of 3 · See all- K192809Dental HandpieceMicro-Nx Co., Ltd. · 2020 · cites it directly2descendants
- K220577Dental Handpiece, Model CA160, CA160L, and CA500LMicro-Nx Co., Ltd. · 2022 · 2 generations on1descendant
- K232810Dental Handpiece, Wireless Endodontic Handpiece, endoitMicro-Nx Co., Ltd. · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K070663 | A-Dec/W&H Synea Air-Driven Highspeed Handpiece, Model TA-98, TA-97, a-Dec/W&H… | A-Dec, Inc. | 2007 | — |
| −1 | K143465 | MASTERmatic LUX | Kaltenbach & Voigt GmbH | 2015 | — |
| 0 (this device) | K163239 | SMARTmatic | Kaltenbach & Voigt GmbH | 2017 | — |
| +1 | K192809 | Dental Handpiece | Micro-Nx Co., Ltd. | 2020 | — |
| +2 | K220577 | Dental Handpiece, Model CA160, CA160L, and CA500L | Micro-Nx Co., Ltd. | 2022 | — |
| +3 | K232810 | Dental Handpiece, Wireless Endodontic Handpiece, endoit | Micro-Nx Co., Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K143465 | MASTERmatic LUXSummary page 4…piece and accessories, per 21 CFR § 872.4200 Device Class - Class I Product Code - EFA Devices for Which Substantial Equivalence is Claimed: MASTERmatic LUX (K143465) marketed by Kaltenbach & Voigt GmbH. Trade Name - MASTERmatic LUX Common Name - Handpiece, belt and/or gear driven, d… | 2015 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192809 | Dental Handpiece | 2020 | 2 |
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 10 years and passes through 2 companies; a new generation was cleared every 7.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K192809 (Micro-Nx Co., Ltd., 2020) has gone furthest, with 2 descendants of its own.
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. 2017, 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 SMARTmatic 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K163239 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163239: SMARTmatic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163239
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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