Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Dentalez with 7 510(k) clearances. The most recent is a 510(k) clearance dated Jan 6, 2020: SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece, ….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Jan 6, 2020 | SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece, SD500 Pro LubeFree High Speed Handpiece, Pro Lubricated High Speed HandpieceK192412 · EFB | 510(k) clearances |
| Mar 28, 2018 | Concentrix MX-AC High-Speed HandpieceK173465 · EFB | 510(k) clearances |
| Jan 19, 2017 | Titan 3 Low Speed Angle AttachmentsK162397 · EGS | 510(k) clearances |
| Apr 8, 2016 | 430 Torque High-Speed Handpiece Series - 430 SWL Torque High Speed Handpiece, 430 SW Torque High Speed HandpieceK153411 · EFB | 510(k) clearances |
| Jan 23, 2012 | CONCENPIECE,HIGH-SPEED HANDPIECE SERIESK113301 · EFB | 510(k) clearances |
| Dec 28, 2009 | STARCARE HANDPIECE MAINTENANCE UNITK093072 · EFB | 510(k) clearances |
| Jun 15, 2007 | PROPHY STAR 3 HYGIENE HANDPIECE, MODEL 264422K070869 · EFB | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
