510(k) · Cleared
ClearedSolara Series Comprised of the Solara High Speed Dental Handpiece and the Solara Plus High Speed Dental Handpiece
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentalez Group · EBF Material, Tooth Shade, Resin
Cleared on Apr 29, 2003 as substantially equivalent to K960719 (Dentalez Group, 1996) and 1 other predicate after a 105-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Apr 29, 2003
- Review
- 105 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K960719 (1996). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK960719 Star Dental 430 Series High Speed HandpieceDentalez Group · 1996 · Recalled
- This deviceK030133 Solara Series Comprised of the Solara High Speed Dental Handpiece…Dentalez Group · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K960719 | Star Dental 430 Series High Speed Handpiece | Dentalez Group | 1996 | 1 |
| 0 (this device) | K030133 | Solara Series Comprised of the Solara High Speed Dental Handpiece and the… | Dentalez Group | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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 EBF? 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 EBF device
- #1 K202846 Tera Harzscore 18.5 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K960719 | Star Dental 430 Series High Speed HandpieceSummary page 1…tal Handpiece Classification: Dental handpiece and accessories (per 21 CFR 8 7 ~ 4 2 0 0 ) Predicate Device: StarDental430 Series High Speed Handpiece (K960719 and K 982593) NSK TI-Max Titanium Handpiece Device Descriptionfintended Use: The Solara Series High… | 1996 |
| * | K982593 | Lube Free Autochuck Turbine with Vortex Air Seal for Use with Star Dental 430 Series…Summary page 1…e Classification: Dental handpiece and accessories (per 21 CFR 8 7 ~ 4 2 0 0 ) Predicate Device: StarDental430 Series High Speed Handpiece (K960719 and K 982593) NSK TI-Max Titanium Handpiece Device Descriptionfintended Use: The Solara Series High Speed Dental… | 1998 |
| * | — | NSK TI-Max Titanium Handpiece Named without a submission number |
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?
- 1 of the 2 ancestors has a recall of any class.
- 5 other devices also cite its predicate K960719.
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EBF
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EBF
43in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EBF
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EBF
1in 2025
MAUDE reports naming product code EBF, 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 | 19 | 49 | 1 | 6 |
| 2008 | 14 | 79 | 42 | 10 |
| 2009 | 20 | 84 | 1 | 8 |
| 2010 | 19 | 75 | 6 | 31 |
| 2011 | 19 | 81 | 7 | 31 |
| 2012 | 11 | 86 | 0 | 62 |
| 2013 | 13 | 153 | 0 | 246 |
| 2014 | 10 | 112 | 0 | 195 |
| 2015 | 17 | 123 | 0 | 119 |
| 2016 | 20 | 205 | 0 | 143 |
| 2017 | 15 | 108 | 4 | 42 |
| 2018 | 15 | 115 | 0 | 8 |
| 2019 | 17 | 159 | 2 | 11 |
| 2020 | 15 | 190 | 1 | 2 |
| 2021 | 13 | 178 | 0 | 2 |
| 2022 | 17 | 63 | 0 | 2 |
| 2023 | 9 | 87 | 0 | 8 |
| 2024 | 18 | 120 | 0 | 5 |
| 2025 | 15 | 43 | 0 | 1 |
| 2026 | 16 | 59 | 2 | — |
What is it indicated for?
High speed handpieces are used intraorally by trained dental professionals for drilling and preparation of dental cavities for restoration, such as fillings. Tlie intended use of this device is identical to the predicate 430 series handpiece currently marketed under 510(k) numbers K960719 and K982593.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030133 · printed Nov 4, 2026
Cite this page
510(k) Report. “K030133: Solara Series Comprised of the Solara High Speed Dental Handpiece and the Solara Plus High Speed Dental Handpiece.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K030133
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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