510(k) · Cleared
ClearedProphy Star 3 Hygiene Handpiece, Model 264422
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentalez, Inc. · EFB Handpiece, Air-Powered, Dental
Cleared on Jun 15, 2007 as substantially equivalent to K896877 (Micro Motors, Inc., 1990) after a 78-day review. Its family tree reaches back 1 generation to 1990. 5 later devices descend from it.
- Decided
- Jun 15, 2007
- Review
- 78 days
- Class
- Class I
- Product code
- EFB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K896877 (1990). 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK896877 Dental Air Motors (Several Models)Micro Motors, Inc. · 1990
- This deviceK070869 Prophy Star 3 Hygiene Handpiece, Model 264422Dentalez, Inc. · 2007
- Descendant · cites it directly · 3 of its ownK073652 ND Low Speed Airmotor and Handpiece, Highspeed Airturbine Handpiece…Nakamura Magnifier Co., Ltd. · 2008
- Descendant · 2 generations on · 0 of its ownK262144 DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor HandpieceSETAGAYA SEIKI Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK170261 Premium Plus Prophy Air MotorPremium Plus International Limited · 2017
- Descendant · 2 generations on · 0 of its ownK141125 U-Type Contra Angle, U-Type Sectional Contra AngleHandpiece Headquarters · 2014
- Descendant · 2 generations on · 0 of its ownK090055 Low & High Speed KitDpm USA Corp. · 2009
Most influential descendants
Showing 5 of 5 · See all- K073652ND Low Speed Airmotor and Handpiece, Highspeed Airturbine Handpiece, E-Type Straight…Nakamura Magnifier Co., Ltd. · 2008 · cites it directly3descendants
- K262144DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor HandpieceSETAGAYA SEIKI Co., Ltd. · 2026 · 2 generations on0descendants
- K170261Premium Plus Prophy Air MotorPremium Plus International Limited · 2017 · cites it directly0descendants
- K141125U-Type Contra Angle, U-Type Sectional Contra AngleHandpiece Headquarters · 2014 · 2 generations on0descendants
- K090055Low & High Speed KitDpm USA Corp. · 2009 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K896877 | Dental Air Motors (Several Models) | Micro Motors, Inc. | 1990 | — |
| 0 (this device) | 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 | — |
| +2 | K262144 | DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece | SETAGAYA SEIKI Co., Ltd. | 2026 | — |
| +1 | K170261 | Premium Plus Prophy Air Motor | Premium Plus International Limited | 2017 | — |
| +2 | K141125 | U-Type Contra Angle, U-Type Sectional Contra Angle | Handpiece Headquarters | 2014 | — |
| +2 | K090055 | Low & High Speed Kit | Dpm USA Corp. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 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? (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 |
|---|---|---|---|
| * | K896877 | Dental Air Motors (Several Models)Summary page 1…ntal handpiece and accessories (per 21 CFR 872.4200) Predicate Device: StarDental Prophy Star II Hygiene Handpiece Micro Motors PHP 100 Prophy Handpiece (K896877) StarDental '3* Device Description/Intended Use: The Prophy St… | 1990 |
| * | — | StarDental Prophy Star II Hygiene Handpiece Named without a submission number |
What descends from it? (5)
2 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?
- Its one ancestor has no recall.
- Of its descendants, K073652 (Nakamura Magnifier Co., Ltd., 2008) has gone furthest, with 3 descendants of its own.
How does its category compare?
All EFB devicesEFB Handpiece, Air-Powered, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
The prophy handpiece is used by trained dental professionals to perform dental prophylaxis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070869 · printed Nov 4, 2026
Cite this page
510(k) Report. “K070869: Prophy Star 3 Hygiene Handpiece, Model 264422.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070869
Report an extraction error
Are you the manufacturer?
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