# K030133: Solara Series Comprised of the Solara High Speed Dental Handpiece and the Solara Plus High Speed Dental Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: Dentalez Group
- Decided: Apr 29, 2003 after 105 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K960719 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960719: Star Dental 430 Series High Speed Handpiece, Dentalez Group (1996) Summary page 1.
- K982593: Lube Free Autochuck Turbine with Vortex Air Seal for Use with Star Dental 430 Series Lube Free High Speed Dental Handpie, Dentalez Group (1998) Summary page 1.
- (no number) NSK TI-Max Titanium Handpiece: named in the summary without a submission number

## Indications for use
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.

Source page: https://510kreport.com/device/K030133
Methodology: https://510kreport.com/methodology