510(k) · Cleared
ClearedDisposable Prophy Angle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pacific Care Limited · EGS Handpiece, Contra- And Right-Angle Attachment, Dental
Cleared on May 28, 2025 as substantially equivalent to K220346 (Ajk Engineering, Inc., 2022) and 1 other predicate after a 415-day review. Its family tree reaches back 2 generations to 2003.
- Decided
- May 28, 2025
- Review
- 415 days
- Class
- Class I
- Product code
- EGS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K030603 (2003). 3 ancestors in all, the oldest K790722 (1979). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K030603 | Proangle Disposable Prophy Angle | Pac-Dent International (Suzhou), Ltd. | 2003 | — |
| −1 | K220346 | Lotus Prophy Angle | Ajk Engineering, Inc. | 2022 | — |
| 0 (this device) | K240950 | Disposable Prophy Angle | Pacific Care Limited | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 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? (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 |
|---|---|---|---|
| * | K220346 | Lotus Prophy AngleSummary page 5…r 872.4200 Product Code(s) EGS | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K220346 Lotus Prophy Angle EGS K790722 Prophylaxis Angle EGS Device Description Summary 21 CFR 807.92(a)(4) Plastic one-piece housing (e… | 2022 |
| * | K790722 | Prophylaxis AngleSummary page 5…| Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K220346 Lotus Prophy Angle EGS K790722 Prophylaxis Angle EGS Device Description Summary 21 CFR 807.92(a)(4) Plastic one-piece housing (external casing) with 1 internal… | 1979 |
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 22 years and passes through 3 companies; a new generation was cleared every 19.6 years on median.
- None of the 3 ancestors has a recall.
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. 2025, 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 intended use of DPA is for polishing and cleaning teeth.
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/K240950 · printed Nov 4, 2026
Cite this page
510(k) Report. “K240950: Disposable Prophy Angle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K240950
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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