510(k) · Cleared
ClearedND Low Speed Airmotor and Handpiece, Highspeed Airturbine Handpiece, E-Type Straight Nosecone and Contra Angle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nakamura Magnifier Co., Ltd. · EFB Handpiece, Air-Powered, Dental
Cleared on Mar 20, 2008 as substantially equivalent to K070869 (Dentalez, Inc., 2007) and 5 other predicates after an 85-day review. Its family tree reaches back 2 generations to 1990. 3 later devices descend from it.
- Decided
- Mar 20, 2008
- Review
- 85 days
- Class
- Class I
- Product code
- EFB
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 2 generations to K896877 (1990). 7 ancestors in all, the oldest K790722 (1979). 3 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK896877 Dental Air Motors (Several Models)Micro Motors, Inc. · 1990
- 1 generation backK070869 Prophy Star 3 Hygiene Handpiece, Model 264422Dentalez, Inc. · 2007
- This deviceK073652 ND Low Speed Airmotor and Handpiece, Highspeed Airturbine Handpiece…Nakamura Magnifier Co., Ltd. · 2008
- Descendant · cites it directly · 0 of its ownK262144 DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor HandpieceSETAGAYA SEIKI Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK141125 U-Type Contra Angle, U-Type Sectional Contra AngleHandpiece Headquarters · 2014
- Descendant · cites it directly · 0 of its ownK090055 Low & High Speed KitDpm USA Corp. · 2009
Most influential descendants
Showing 3 of 3 · See all- K262144DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor HandpieceSETAGAYA SEIKI Co., Ltd. · 2026 · cites it directly0descendants
- K141125U-Type Contra Angle, U-Type Sectional Contra AngleHandpiece Headquarters · 2014 · cites it directly0descendants
- K090055Low & High Speed KitDpm USA Corp. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K896877 | Dental Air Motors (Several Models) | Micro Motors, Inc. | 1990 | — |
| −1 | K070869 | Prophy Star 3 Hygiene Handpiece, Model 264422 | Dentalez, Inc. | 2007 | — |
| 0 (this device) | K073652 | ND Low Speed Airmotor and Handpiece, Highspeed Airturbine Handpiece, E-Type… | Nakamura Magnifier Co., Ltd. | 2008 | — |
| +1 | K262144 | DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece | SETAGAYA SEIKI Co., Ltd. | 2026 | — |
| +1 | K141125 | U-Type Contra Angle, U-Type Sectional Contra Angle | Handpiece Headquarters | 2014 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
| 2026 | 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 EFB? 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 EFB device
- #1 K262144 DIAMED Handpiece;DIAMED Airmotor;DIAMED…score 13.3 · 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? (6)
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 |
|---|---|---|---|
| * | K070869 | Prophy Star 3 Hygiene Handpiece, Model 264422Summary page 1…ormal correspondence with FDA: B0o00016 The Common or Usual Name: Air-Powered Low Speed Handpiece The Predicate Device: 510(k) Number: K070869 Trade or Propriety or Model Name: PROPHY STAR 3 HYGIENE HANDPIECE, MODEL 264422 Manufacturer: DENTALEZ, I… | 2007 |
| * | K896878 | Handpiece System with Motor (Several Models)Summary page 2…ior formal correspondence with FDA: B000016 The Common or Usual Name: Air-Powered Low Speed Motor The Predicate Device: 510(k) Number: K896878 Trade or Propriety or Model Name: Dual Low Speed Motor HANDPIECE SYSTEM WITH… | 1990 |
| * | K863677 | Tradition High Speed HandpieceSummary page 3…ior formal correspondence with FDA: B000016 The Common or Usual Name: Air-Powered High Speed Handpiece The Predicate Devices: 510(k) Number: K863677 Trade or Propriety or Model Name: TRADITION HIGHSPEED HANDPIECE Manufacturer: MIDWEST Description I Intended Use:… | 1986 |
| * | K792445 | MW Straight AttachmentSummary page 5…espondence with FDA: B000017 The Common or Usual Name : Straight Angle Dental Handpiece Attachment The Predicate Device: 510(k) Number: K792445 Trade or Propriety or Model Name : MW STRAIGHT ATTACHMENT Manufacturer: MIDWEST Description I Intended Use:… | 1979 |
| * | K962540 | E-Type Contra Angle Nac-ESummary page 7…dence with FDA: 8000017 The Common or Usual Name : E-type Contra Angle Dental Handpiece Attachment The Predicate Device: 510(k) Number: K962540 Trade or Propriety or Model Name: E-TYPE CONTRA ANGLE NAC-E Manufacturer: NSK NAKANISHI, INC. Description / Inten… | 1996 |
| * | K790722 | Prophylaxis AngleSummary page 9…ence with FDA: B,000017 The Common or Usual Name: U-type Contra Angle Dental Handpiece Attachment The Predicate Device: 510(k) Number: K790722 Trade or Propriety or Model Name: PROHYLAXIS ANGLE Manufacturer: YOUNG DENTAL MANUFACTURING CO, LLC. Description… | 1979 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 18 years and passes through 3 companies; a new generation was cleared every 17.3 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K262144 (SETAGAYA SEIKI Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K070869.
How does its category compare?
All EFB devicesEFB Handpiece, Air-Powered, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · EFB
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EFB
209in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EFB
No recall names EFB since 2007.
Adverse event reports per year · EFB
83in 2025
MAUDE reports naming product code EFB, 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 | 12 | 61 | 0 | 13 |
| 2008 | 7 | 97 | 0 | 19 |
| 2009 | 11 | 120 | 0 | 40 |
| 2010 | 8 | 116 | 0 | 78 |
| 2011 | 4 | 168 | 0 | 96 |
| 2012 | 8 | 130 | 0 | 97 |
| 2013 | 3 | 207 | 0 | 61 |
| 2014 | 7 | 200 | 0 | 73 |
| 2015 | 7 | 296 | 0 | 87 |
| 2016 | 3 | 205 | 0 | 122 |
| 2017 | 7 | 246 | 0 | 153 |
| 2018 | 3 | 210 | 0 | 81 |
| 2019 | 3 | 348 | 0 | 117 |
| 2020 | 5 | 259 | 0 | 94 |
| 2021 | 2 | — | 0 | 123 |
| 2022 | 5 | 430 | 0 | 157 |
| 2023 | 4 | 158 | 0 | 116 |
| 2024 | 5 | 209 | 0 | 104 |
| 2025 | 1 | — | 0 | 83 |
| 2026 | 4 | 252 | 0 | — |
What is it indicated for?
ND air powered low speed airmotor is used to power various attachment which helps dental clinician perform various dental procedures. All the devices are autoclavable. ND air powered low speed airmotor is used to power various U-type attachment which helps dental clinician perform the hygiene dentistry work. All the devices are autoclavable. ND highspeed airturbine handpiece is an air-powered dental handpiece for removing carious material and excess…
Read the full statement (240 words)
ND air powered low speed airmotor is used to power various attachment which helps dental clinician perform various dental procedures. All the devices are autoclavable.
ND air powered low speed airmotor is used to power various U-type attachment which helps dental clinician perform the hygiene dentistry work. All the devices are autoclavable.
ND highspeed airturbine handpiece is an air-powered dental handpiece for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restoration and polishing teeth. All the devices are autoclavable.
ND straight nosecone is powered by either lowspeed airmotor or electric micromotor for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restorations and polishing teeth. ES-30A is E-type 1:1 ratio, ESG-3OAR is E-type 4:1 ratio, and MWS-30A is Midwest-type 1:1 ratio. All the devices are autoclavable. They accept 2.35mm (3/32") standard burs and can have prophy angles mounted.
ND e-type contra angle is powered by either lowspeed airmotor or electric micromotor for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restorations and polishing teeth. EC-20L and EC-30BL are 1:1 ratio, EG-20L is 4:1 ratio, and EGG-20L is 16:1 ratio, All of the devices are autoclavable.
ND u-type prophylaxis angle is used mounted on U-type nose attachment powered by either lowspeed airmotor or electric micromotor for hygiene dentistry work. All the devices are fully autoclavable.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073652 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073652: ND Low Speed Airmotor and Handpiece, Highspeed Airturbine Handpiece, E-Type Straight Nosecone and Contra Angle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073652
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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