510(k) · Cleared
ClearedProsthodontic Screwdriver , Model IA-400
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W&H Dentalwerk Buermoos GmbH · EKX Handpiece, Direct Drive, Ac-Powered
Cleared on Jul 9, 2010 as substantially equivalent to K052741 (W&H Dentalwerk Buermoos GmbH, 2006) and 1 other predicate after a 128-day review. Its family tree reaches back 2 generations to 2001. 2 later devices descend from it.
- Decided
- Jul 9, 2010
- Review
- 128 days
- Class
- Class I
- Product code
- EKX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K002469 (2001). 4 ancestors in all, the oldest K970339 (1997). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK002469 Implantmed SI-95 115 (100-130 V) and SI-95 230 (220-240 V)W&H Dentalwerk Buermoos GmbH · 2001
- 1 generation backK052741 Implantmed SI-915 (115V Version); Implantmed SI-923 (230V Version)…W&H Dentalwerk Buermoos GmbH · 2006
- This deviceK100600 Prosthodontic Screwdriver , Model IA-400W&H Dentalwerk Buermoos GmbH · 2010
- Descendant · cites it directly · 1 of its ownK110278 Cordless Prosthodontic Screwdriver with Torque Calibration System…Nakanishi, Inc. · 2012
- Descendant · 2 generations on · 0 of its ownK161500 Meg-TorqMicro-Nx Co., Ltd. · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002469 | Implantmed SI-95 115 (100-130 V) and SI-95 230 (220-240 V) | W&H Dentalwerk Buermoos GmbH | 2001 | — |
| −1 | K052741 | Implantmed SI-915 (115V Version); Implantmed SI-923 (230V Version) Incl.… | W&H Dentalwerk Buermoos GmbH | 2006 | — |
| 0 (this device) | K100600 | Prosthodontic Screwdriver , Model IA-400 | W&H Dentalwerk Buermoos GmbH | 2010 | — |
| +1 | K110278 | Cordless Prosthodontic Screwdriver with Torque Calibration System, Model ISD900 | Nakanishi, Inc. | 2012 | — |
| +2 | K161500 | Meg-Torq | Micro-Nx Co., Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2017 | 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 EKX? 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 EKX device
- #1 K261987 Reusable SmartPegscore 13.2 · 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 |
|---|---|---|---|
| * | K052741 | Implantmed SI-915 (115V Version); Implantmed SI-923 (230V Version) Incl. AccessoriesSummary page 1…ed Regulation Number 21 CFR872.4200 Product Code EKX -"imp lantM EDS51-915", deared by W&H Dentaiwerk Buermoos under K052741 Predicate Devices + "WS-75 E/KM". cleared by W&H Dentalwerk Buermoos as an accessory to te… | 2006 |
| * | K090931 | Cordless Endo Handpieces EB-300, Entran and EB-300 S, S5 Endo MotorSummary page 2…400" represents a device combining the technical principle of the cordless ENDO- Handpiece 'ENTRAN" (510(k) no. K090931) with a special field of applicability of W&H's drive unit "implantMED SI-915", provided… | 2009 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110278 | Cordless Prosthodontic Screwdriver with Torque Calibration System, Model ISD900 | 2012 | 1 |
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 9 years and passes through 1 company; a new generation was cleared every 4.9 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K110278 (Nakanishi, Inc., 2012) has gone furthest, with 1 descendant of its own.
- 7 other devices also cite its predicate K052741.
How does its category compare?
All EKX devicesEKX Handpiece, Direct Drive, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · EKX
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EKX
244in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EKX
No recall names EKX since 2007.
Adverse event reports per year · EKX
9in 2025
MAUDE reports naming product code EKX, 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 | 9 |
| 2008 | 3 | 101 | 0 | 10 |
| 2009 | 4 | 186 | 0 | 11 |
| 2010 | 3 | 114 | 0 | 20 |
| 2011 | 4 | 75 | 0 | 6 |
| 2012 | 2 | — | 0 | 27 |
| 2013 | 2 | — | 0 | 45 |
| 2014 | 3 | 251 | 0 | 102 |
| 2015 | 3 | 178 | 0 | 68 |
| 2016 | 3 | 274 | 0 | 66 |
| 2017 | 2 | — | 0 | 10 |
| 2018 | 3 | 293 | 0 | 49 |
| 2019 | 3 | 349 | 0 | 56 |
| 2020 | 1 | — | 0 | 67 |
| 2021 | 5 | 214 | 0 | 79 |
| 2022 | 3 | 359 | 0 | 37 |
| 2023 | 4 | 152 | 0 | 14 |
| 2024 | 4 | 276 | 0 | 19 |
| 2025 | 5 | 244 | 0 | 9 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The drive unit is an electrically controlled screwdriver with
adjustable torques to tighten and unscrew prosthodontic screws.
Consisting of: - Cordless drive unit
- Mechanical transmission instrument 80:1
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100600 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100600: Prosthodontic Screwdriver , Model IA-400.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100600
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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