510(k) Report

FDA applicant

Premier Dental Company Products

Plymouth Meeting, PA3 decisions2015–20190 recalls

FDA records 3 decisions for Premier Dental Company Products (Plymouth Meeting, PA) from 2015 to 2019: 3 510(k) clearances. Most are in product codes EKX (Handpiece, Direct Drive, Ac-Powered) and EBC (Sealant, Pit And Fissure, And Conditioner). 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 Premier Dental Company Products’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2015: 12016: 12019: 1
2015high 1 (2015) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Premier Dental Company Products by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • EKXHandpiece, Direct Drive, Ac-Powered1decision
  • EBCSealant, Pit And Fissure, And Conditioner1decision
  • EMACement, Dental1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K161580Premier SealantPremier Dental Company Products · 20161cites it

What has FDA decided for it lately?

  • K180682AeroPro Cordless Prophy SystemPremier Dental Company Products · 2019
  • K161580Premier SealantPremier Dental Company Products · 2016
  • K150601Zeramic Adhesive Resin CementPremier Dental Company Products · 2015

All 3 as Premier Dental Company Products →