510(k) · Cleared
ClearedLow & High Speed Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dpm USA Corp. · EFA Handpiece, Belt And/Or Gear Driven, Dental
Cleared on Oct 27, 2009 as substantially equivalent to K073652 (Nakamura Magnifier Co., Ltd., 2008) after a 292-day review. Its family tree reaches back 3 generations to 1990.
- Decided
- Oct 27, 2009
- Review
- 292 days
- Class
- Class I
- Product code
- EFA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K896877 (1990). 8 ancestors in all, the oldest K790722 (1979). No later device cites it as a predicate yet.
- Root · 3 generations backK896877 Dental Air Motors (Several Models)Micro Motors, Inc. · 1990
- 2 generations backK070869 Prophy Star 3 Hygiene Handpiece, Model 264422Dentalez, Inc. · 2007
- 1 generation backK073652 ND Low Speed Airmotor and Handpiece, Highspeed Airturbine Handpiece…Nakamura Magnifier Co., Ltd. · 2008
- This deviceK090055 Low & High Speed KitDpm USA Corp. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K896877 | Dental Air Motors (Several Models) | Micro Motors, Inc. | 1990 | — |
| −2 | K070869 | Prophy Star 3 Hygiene Handpiece, Model 264422 | Dentalez, Inc. | 2007 | — |
| −1 | K073652 | ND Low Speed Airmotor and Handpiece, Highspeed Airturbine Handpiece, E-Type… | Nakamura Magnifier Co., Ltd. | 2008 | — |
| 0 (this device) | K090055 | Low & High Speed Kit | Dpm USA Corp. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 2 | 0 |
| 1986 | 1 | 0 |
| 1990 | 1 | 0 |
| 1996 | 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 |
|---|---|---|---|
| * | K073652 | ND Low Speed Airmotor and Handpiece, Highspeed Airturbine Handpiece, E-Type Straight…Summary page 1…r:21 CFR 872.4200 V. Product Code: EFB Device for Which Substantial Equivalence is Claims: 1. High & Low Speed Handpiece, with E-Type contra-angle 2. 510 (k) 073652 3. Manufacture: NAKAMURA MAGNIFIER CO., LTD. Device Description/Intended Use: The Elite low speed air motor with Elite "E" con… | 2008 |
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 19 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- None of the 8 ancestors has a recall.
- 2 other devices also cite its predicate K073652.
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. 2009, 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 Elite low speed air motor with Elite "E" contra-angle is to power various attachments which helps the dental clinician perform various dental procedures, removing carious material and excess filling material, cavity and crown preparation,root canal preparations,restorationand polishing teeth.
The Medidental high speed handpiece is an air-powereddental handpiece which helps the dental clinician perform various dental procedures such as removing carious materialand excess filling material, cavity and crown preparation,root canal preparations,restoration and polishing teeth.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090055 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090055: Low & High Speed Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090055
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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