Solara Series Comprised of the Solara High Speed Dental Handpiece and the Solara Plus High Speed Dental Handpiece

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K030133 ↗

FDA Product Code

EBF

Device Class

Class II

Regulation

21 CFR Part 872.3690

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• High Speed Non-Fiber Optic Swivel Handpiece

  Class II

  FDA 510(k) K902402 Active Cleared 29 Aug 1990

• Stardental Titan 3 Lubefree Motor Attachments

  Class I

  FDA 510(k) K983574 Active Cleared 8 Jan 1999

• Portable Hdx Intraoral X-Ray

  Class II

  FDA 510(k) K021378 Active Cleared 7 Jun 2002

• Star Titan Series Motors & Attachments

  Class I

  FDA 510(k) K960260 Active Cleared 28 Mar 1996

• Handpiece Fiber Optic System Improvement Feature

  Class I

  FDA 510(k) K896361 Active Cleared 2 Feb 1990

• Stardental Axcs Sterile Water System

  Class I

  FDA 510(k) K990844 Active Cleared 28 May 1999

See all devices from Dentalez Group →