510(k) · Cleared
ClearedU-Type Contra Angle, U-Type Sectional Contra Angle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Handpiece Headquarters · EGS Handpiece, Contra- And Right-Angle Attachment, Dental
Cleared on Oct 23, 2014 as substantially equivalent to K073652 (Nakamura Magnifier Co., Ltd., 2008) after a 175-day review. Its family tree reaches back 3 generations to 1990.
- Decided
- Oct 23, 2014
- Review
- 175 days
- Class
- Class I
- Product code
- EGS
- 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 deviceK141125 U-Type Contra Angle, U-Type Sectional Contra AngleHandpiece Headquarters · 2014
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) | K141125 | U-Type Contra Angle, U-Type Sectional Contra Angle | Handpiece Headquarters | 2014 | — |
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 EGS? 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 EGS device
- #1 K251869 Disposable Prophy Angle (3399-60, 3399-090…score 10.0 · 1 generation · 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 |
|---|---|---|---|
| * | K073652 | ND Low Speed Airmotor and Handpiece, Highspeed Airturbine Handpiece, E-Type Straight…Summary page 4…ories. EGS e- Substantial Equivalency is claimed against the following devices: ND U-TYPE PROPHYLAXIS ANGLES (SEVERAL MODELS) NAKAMURA DENTAL HANDPIECE MFG. CO., LTD. - K073652 f- Description of the device: U-Type contra angles and U-Type sectional contra angles are used to mount on U-Type Nose Attachment… | 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 24 years and passes through 4 companies; a new generation was cleared every 6.6 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 EGS devicesEGS Handpiece, Contra- And Right-Angle Attachment, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · EGS
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EGS
189in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EGS
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EGS
82in 2025
MAUDE reports naming product code EGS, 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 | 2 |
| 2008 | 0 | — | 0 | 14 |
| 2009 | 1 | — | 0 | 45 |
| 2010 | 2 | — | 0 | 74 |
| 2011 | 3 | 104 | 0 | 2 |
| 2012 | 3 | 288 | 0 | 3 |
| 2013 | 1 | — | 0 | 2 |
| 2014 | 2 | — | 0 | 38 |
| 2015 | 3 | 245 | 0 | 166 |
| 2016 | 0 | — | 0 | 299 |
| 2017 | 2 | — | 0 | 316 |
| 2018 | 1 | — | 0 | 230 |
| 2019 | 3 | 276 | 0 | 219 |
| 2020 | 1 | — | 0 | 191 |
| 2021 | 1 | — | 0 | 294 |
| 2022 | 4 | 189 | 0 | 279 |
| 2023 | 1 | — | 1 | 115 |
| 2024 | 1 | — | 0 | 81 |
| 2025 | 2 | — | 0 | 82 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The U-Type Contra Angles and U-Type Sectional Contra Angles are used to mount on
U-Type Nose Attachments and powered by either low speed air motors or electric micro
motors. These U-Type are intended for removing carious material, cavity and crown
preparations, finishing tooth preparations, reducing hard tooth structures, restorations and
polishing teeth.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141125 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141125: U-Type Contra Angle, U-Type Sectional Contra Angle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141125
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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