510(k) Report

FDA applicant

Hu-Friedy Mfg. Co., Inc.

Chicago, IL9 decisions1984–20120 recalls

FDA records 9 decisions for Hu-Friedy Mfg. Co., Inc. (Chicago, IL) from 1984 to 2012: 9 510(k) clearances. Most are in product codes ELC (Scaler, Ultrasonic) and FSM (Tray, Surgical, Instrument). Its devices cite 6 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Hu-Friedy Mfg. Co., LLC”.

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 Hu-Friedy Mfg. Co., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2007: 12008: 12010: 12012: 1
2007high 1 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Hu-Friedy Mfg. Co., 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?

  • ELCScaler, Ultrasonic5decisions
  • FSMTray, Surgical, Instrument1decision
  • EJISyringe, Cartridge1decision
  • EKMGutta-Percha1decision
  • EKJBurnisher, Operative1decision

Whose devices does it build on?

Its devices cite 6 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 1 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.

  • K844002HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 19842cite it
  • K953919Dental Ultrasonic Scaler InsertsHu-Friedy Mfg. Co., Inc. · 19952cite it
  • K012060Modification to:HU-Friedy Brand Satin Swivel Ultrasonic InsertHu-Friedy Mfg. Co., Inc. · 20012cite it

What has FDA decided for it lately?

  • K120659HU-Friedy Dental Cartridge SyringeHu-Friedy Mfg. Co., LLC · 2012
  • K100401Swerv Magnetostrictive Ultrasonic Scaler SystemHu-Friedy Mfg. Co., Inc. · 2010
  • K073369EI Downpak Barrier SleevesHu-Friedy Mfg. Co., Inc. · 2008
  • K070975Symmetry IQ, Model 2000 Series, 3000 SeriesHu-Friedy Mfg. Co., Inc. · 2007
  • K053178Symmetry S-Series Piezoelectric Scaling TipsHu-Friedy Mfg. Co., Inc. · 2006
  • K012060Modification to:HU-Friedy Brand Satin Swivel Ultrasonic InsertHu-Friedy Mfg. Co., Inc. · 2001
  • K953919Dental Ultrasonic Scaler InsertsHu-Friedy Mfg. Co., Inc. · 1995
  • K912473Accu-Placer TM KitHu-Friedy Mfg. Co., Inc. · 1991

All 8 as Hu-Friedy Mfg. Co., Inc. →The one decision as Hu-Friedy Mfg. Co., LLC →