510(k) Report

FDA applicant

Dentalez, Inc.

Lancaster, PA7 decisions2007–20200 recalls

FDA records 7 decisions for Dentalez, Inc. (Lancaster, PA) from 2007 to 2020: 7 510(k) clearances. Most are in product codes EFB (Handpiece, Air-Powered, Dental) and EGS (Handpiece, Contra- And Right-Angle Attachment…). Since 2016 its 510(k)s took a median of 135 days from receipt to decision, against 210 for FDA’s reviews in the same codes and years. Its devices cite 9 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided Dentalez, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2007: 12009: 12012: 12016: 12017: 12018: 12020: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Dentalez, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Dentalez, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • EFBHandpiece, Air-Powered, Dental6decisions
  • EGSHandpiece, Contra- And Right-Angle Attachment, Dental1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 135 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 210 days; 3 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 9 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 2 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K070869Prophy Star 3 Hygiene Handpiece, Model 264422Dentalez, Inc. · 20072cite it
  • K153411430 Torque High-Speed Handpiece Series - 430 SWL Torque High Speed Handpiece, 430 SW Torque High Speed…Dentalez, Inc. · 20161cites it
  • K113301Concenpiece,High-Speed Handpiece SeriesDentalez, Inc. · 20121cites it

What has FDA decided for it lately?

  • K192412SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece, SD500 Pro LubeFree…Dentalez, Inc. · 2020
  • K173465Concentrix MX-AC High-Speed HandpieceDentalez, Inc. · 2018
  • K162397Titan 3 Low Speed Angle AttachmentsDentalez, Inc. · 2017
  • K153411430 Torque High-Speed Handpiece Series - 430 SWL Torque High Speed Handpiece, 430 SW Torque High Speed…Dentalez, Inc. · 2016
  • K113301Concenpiece,High-Speed Handpiece SeriesDentalez, Inc. · 2012
  • K093072Starcare Handpiece Maintenance UnitDentalez, Inc. · 2009
  • K070869Prophy Star 3 Hygiene Handpiece, Model 264422Dentalez, Inc. · 2007

All 7 as Dentalez, Inc. →

Other applicant names beginning “Dentalez”

FDA records each applicant name separately; these may or may not be the same firm.

Dentalez Group 13Dentalez, Inc., Stardental Division 2Dentalez Group, Stardental Division 2