510(k) · Cleared
ClearedDental Implant Unit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guilin Aesthedent Medical Instruments Co., Ltd. · EBW Controller, Foot, Handpiece And Cord
Cleared on Apr 11, 2025 as substantially equivalent to K231845 (Foshan Safety Medical Equipment Co., Ltd., 2024) after a 220-day review. Its family tree reaches back 7 generations to 1996.
- Decided
- Apr 11, 2025
- Review
- 220 days
- Class
- Class I
- Product code
- EBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K962071 (1996). No later device cites it as a predicate yet.
- Root · 7 generations backK962071 Spirit S1/S2Pelton & Crane Co. · 1996
- 6 generations backK983242 Sirona C8 Dental Operative Unit with AccessoriesSirona Dental Systems GmbH · 1998
- 5 generations backK032543 Sirona Dental Systems C8+Dental Operative Unit with AccessoriesSirona Dental Systems GmbH · 2003
- 4 generations backK080438 Dental Unit with ChairNorth West Medical Instrument (Group) Co., Ltd. · 2008
- 3 generations backK130410 Dental Unit with ChairXianyang North West Medical Instrument (Group) Co. · 2013
- 2 generations backK142206 Dental UnitZhuhai Siger Medical Equipment Co., Ltd. · 2015
- 1 generation backK231845 Dental unit Model: MareFoshan Safety Medical Equipment Co., Ltd. · 2024
- This deviceK242646 Dental Implant UnitGuilin Aesthedent Medical Instruments Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K962071 | Spirit S1/S2 | Pelton & Crane Co. | 1996 | — |
| −6 | K983242 | Sirona C8 Dental Operative Unit with Accessories | Sirona Dental Systems GmbH | 1998 | — |
| −5 | K032543 | Sirona Dental Systems C8+Dental Operative Unit with Accessories | Sirona Dental Systems GmbH | 2003 | — |
| −4 | K080438 | Dental Unit with Chair | North West Medical Instrument (Group) Co., Ltd. | 2008 | — |
| −3 | K130410 | Dental Unit with Chair | Xianyang North West Medical Instrument (Group) Co. | 2013 | — |
| −2 | K142206 | Dental Unit | Zhuhai Siger Medical Equipment Co., Ltd. | 2015 | — |
| −1 | K231845 | Dental unit Model: Mare | Foshan Safety Medical Equipment Co., Ltd. | 2024 | — |
| 0 (this device) | K242646 | Dental Implant Unit | Guilin Aesthedent Medical Instruments Co., Ltd. | 2025 | — |
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 EBW? 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 EBW device
- #1 K251701 Star E900 Electric Systemscore 12.2 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | K231845 | Dental unit Model: MareSummary page 6… Classification Product Code: EBW Regulation Number: 872.4200 Class: Class I Review Panel: Dental 5. Predicate Device Information: 510(k) Number: K231845 Device Classification Name: Dental Handpiece and Accessories Sponsor: Guilin Woodpecker Medical Instrument Co., Ltd. … | 2024 |
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 29 years and passes through 7 companies; a new generation was cleared every 4.4 years on median.
- None of the 7 ancestors has a recall.
- 1 other device also cites its predicate K231845.
How does its category compare?
All EBW devicesEBW Controller, Foot, Handpiece And Cord: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · EBW
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EBW
220in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EBW
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EBW
13in 2025
MAUDE reports naming product code EBW, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 5 | 112 | 0 | 16 |
| 2010 | 1 | — | 0 | 18 |
| 2011 | 3 | 226 | 0 | 1 |
| 2012 | 1 | — | 0 | 5 |
| 2013 | 1 | — | 1 | 1 |
| 2014 | 3 | 189 | 0 | 4 |
| 2015 | 1 | — | 0 | 13 |
| 2016 | 1 | — | 0 | 6 |
| 2017 | 4 | 227 | 0 | 13 |
| 2018 | 1 | — | 0 | 46 |
| 2019 | 2 | — | 0 | 55 |
| 2020 | 1 | — | 0 | 71 |
| 2021 | 2 | — | 0 | 57 |
| 2022 | 6 | 479 | 0 | 31 |
| 2023 | 0 | — | 0 | 17 |
| 2024 | 4 | 268 | 0 | 14 |
| 2025 | 3 | 220 | 0 | 13 |
| 2026 | 3 | 269 | 0 | — |
What is it indicated for?
Mechanical drive unit with coolant supply for transmission instruments with ISO 3964 (DIN13940) compatible coupling system, for use in dental surgery, implantology and maxillofacial surgery (CMF) for treatment of dental hard tissue.
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/K242646 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242646: Dental Implant Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242646
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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