510(k) · Cleared
ClearedDisposable Prophy Angle (3399-60, 3399-090, 3399-105)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Premium Plus (Dongguan) Limited · EGS Handpiece, Contra- And Right-Angle Attachment, Dental
Cleared on Sep 15, 2025 as substantially equivalent to K100854 (Premium Plus International Limited, 2010) after an 89-day review. Its family tree reaches back 1 generation to 2010.
- Decided
- Sep 15, 2025
- Review
- 89 days
- Class
- Class I
- Product code
- EGS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K100854 (2010). No later device cites it as a predicate yet.
- Root · 1 generation backK100854 Premium Plus Disposable Prophy Angle Model 3399Premium Plus International Limited · 2010
- This deviceK251869 Disposable Prophy Angle (3399-60, 3399-090, 3399-105)Premium Plus (Dongguan) Limited · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K100854 | Premium Plus Disposable Prophy Angle Model 3399 | Premium Plus International Limited | 2010 | — |
| 0 (this device) | K251869 | Disposable Prophy Angle (3399-60, 3399-090, 3399-105) | Premium Plus (Dongguan) Limited | 2025 | — |
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 K240950 Disposable Prophy Anglescore 9.7 · 2 generations · 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 |
|---|---|---|---|
| * | K100854 | Premium Plus Disposable Prophy Angle Model 3399Summary page 5…sories Handpiece, Contra- And Right-Angle Attachment, Dental 872.4200 EGS Predicate Trade Name (Primary Predicate is listed first) 21 CFR 807.92(a)(3) Product Code K100854 Premium Plus Disposable Prophy Angle EGS Device Description Summary 21 CFR 807.92(a)(4) Disposable Prophy Angle is a dental… | 2010 |
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?
- Its one ancestor has no 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?
Disposable Prophy Angle is intended to be attached to a low speed dental handpiece and used by professional dentists and dental hygienists for polishing and cleaning the surface of teeth. It is intended for single use, and should be discarded after each patient.
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/K251869 · printed Nov 4, 2026
Cite this page
510(k) Report. “K251869: Disposable Prophy Angle (3399-60, 3399-090, 3399-105).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K251869
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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