510(k) Report

FDA applicant

Pac-Dent International (Suzhou), Ltd.

Jiangsu Province, CN2 decisions2003–20040 recalls

FDA records 2 decisions for Pac-Dent International (Suzhou), Ltd. (Jiangsu Province, CN) from 2003 to 2004: 2 510(k) clearances. Most are in product codes EGS (Handpiece, Contra- And Right-Angle Attachment…) and ELC (Scaler, Ultrasonic). Its devices cite 1 predicate, 0 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 Pac-Dent International (Suzhou), Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Pac-Dent International (Suzhou), Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Pac-Dent International (Suzhou), Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • EGSHandpiece, Contra- And Right-Angle Attachment, Dental1decision
  • ELCScaler, Ultrasonic1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

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.

  • K030603Proangle Disposable Prophy AnglePac-Dent International (Suzhou), Ltd. · 20031cites it

What has FDA decided for it lately?

  • K033120Scaletron Piezo Ultrasound ScalerPac-Dent International (Suzhou), Ltd. · 2004
  • K030603Proangle Disposable Prophy AnglePac-Dent International (Suzhou), Ltd. · 2003

All 2 as Pac-Dent International (Suzhou), Ltd. →