510(k) · Cleared
ClearedStardental Titan 3 Lubefree Motor Attachments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentalez Group · EGS Handpiece, Contra- And Right-Angle Attachment, Dental
Cleared on Jan 8, 1999 after an 87-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Jan 8, 1999
- Review
- 87 days
- Class
- Class I
- Product code
- EGS
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK983574 Stardental Titan 3 Lubefree Motor AttachmentsDentalez Group · 1999
- Descendant · cites it directly · 0 of its ownK162397 Titan 3 Low Speed Angle AttachmentsDentalez, Inc. · 2017
Most influential descendants
Showing 1 of 1 · See all- K162397Titan 3 Low Speed Angle AttachmentsDentalez, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983574 | Stardental Titan 3 Lubefree Motor Attachments | Dentalez Group | 1999 | — |
| +1 | K162397 | Titan 3 Low Speed Angle Attachments | Dentalez, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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? (6)
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 |
|---|---|---|---|
| * | — | Star low speed motor attachments Named without a submission number | |
| * | — | Midwest low speed motor attachments Named without a submission number | |
| * | — | KAVO low speed motor attachments Named without a submission number | |
| * | — | W&H low speed motor attachments Named without a submission number | |
| * | — | NSK low speed motor attachments Named without a submission number | |
| * | — | Champion Dental low speed motor attachments Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162397 | Titan 3 Low Speed Angle Attachments | 2017 | 0 |
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?
- Of its descendants, K162397 (Dentalez, Inc., 2017) has gone furthest, with 0 descendants of its own.
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.
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?
Low speed dental attachments are used intraorally by trained dental professionals for
drilling and preparation of dental cavities for restoration, such as fillings. Furthermore,
the intended use extends to disking, cavity and crown preps, polishing, post and pin
drifling and pin setting. The intended use is identical to that of the predicate low speed
motor attachments.
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/K983574 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983574: Stardental Titan 3 Lubefree Motor Attachments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983574
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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