510(k) · Cleared
ClearedStar E900 Handpiece Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentalez, Inc., Stardental Division · EGS Handpiece, Contra- And Right-Angle Attachment, Dental
Cleared on Sep 19, 2024 as substantially equivalent to K132356 (Scican GmbH, 2014) after a 240-day review. Its family tree reaches back 2 generations to 2007.
- Decided
- Sep 19, 2024
- Review
- 240 days
- Class
- Class I
- Product code
- EGS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K071891 (2007). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K132356 | Sanao 200L, Sanao 40 /Sanao 40L, Sanao 10L, Sanao Psi / Sanao Pso, Sanao 40STSummary page 5…872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: Class I Product Code: EGS III. PREDICATE DEVICE Clearance: K132356 dated January 31, 2014 Manufacturer: SciCan GmbH Trade/Device Name: Sanao Dental Handpiece Common Name:… | 2014 |
| † | K192412 | SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece… | 2020 |
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 17 years and passes through 3 companies; a new generation was cleared every 10.6 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 2 other devices also cite its predicate K132356.
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. 2024, 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 Star E900 Handpiece Series are intended to be used for general dentistry by trained dental professionals. The intended use of the respective handpieces is dependent on the gear ratio. Star E900 1:5 Handpiece: the removal of decayed matter, cavity and crown preparations, the removal of fillings and surface finishing of tooth and restoration surfaces. Star E900 1:1 Handpiece: Cavity preparations, caries excavation, endodontic applcations, processing of…
Read the full statement (103 words)
The Star E900 Handpiece Series are intended to be used for general dentistry by trained dental professionals. The intended use of the respective handpieces is dependent on the gear ratio.
Star E900 1:5 Handpiece: the removal of decayed matter, cavity and crown preparations, the removal of fillings and surface finishing of tooth and restoration surfaces.
Star E900 1:1 Handpiece: Cavity preparations, caries excavation, endodontic applcations, processing of tooth and restoration surfaces.
Star E900 5:1 Handpiece: Cavity preparations, caries excavation, endodontic applications, processing of tooth and restoration surfaces.
Star E900 1:1 Straight Handpiece: prophylaxis treatment, crown preparations, polshing, finishing of tooth and restoration surfaces
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240183 · printed Nov 4, 2026
Cite this page
510(k) Report. “K240183: Star E900 Handpiece Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K240183
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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