510(k) Report

FDA applicant

Sonendo, Inc.

Laguna Hills, CA9 decisions2013–20213 recalls

FDA records 9 decisions for Sonendo, Inc. (Laguna Hills, CA) from 2013 to 2021: 9 510(k) clearances. Most are in product codes ELC (Scaler, Ultrasonic) and KIF (Resin, Root Canal Filling). Since 2016 its 510(k)s took a median of 76 days from receipt to decision, against 118 for FDA’s reviews in the same codes and years. Its devices cite 11 predicates, 5 of them its own earlier devices. 3 recalls are 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 Sonendo, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2021

2013: 12014: 12015: 12016: 22018: 12019: 12021: 2
2013high 2 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

2in 2022

2019: 12022: 2
2013high 2 (2022) · low 0 (2013)2026

Class I Class II/III not classified

FIG. 1 — Sonendo, Inc. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Sonendo, 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, Ultrasonic7decisions
  • KIFResin, Root Canal Filling2decisions

How long do its 510(k) reviews take?

Since 2016, its 6 510(k)s took a median of 76 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 118 days; 5 of its 6 were faster than that.

Whose devices does it build on?

Its devices cite 11 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 5 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.

  • K160905Sonendo GentleWave SystemSonendo, Inc. · 20162cite it
  • K153157Sonendo Gentle Wave SystemSonendo, Inc. · 20161cites it
  • K133752Sonendo Omniclean Endotherpay System Console, Sonendo Omniclean Molar Procedure KitSonendo, Inc. · 20141cites it
  • K130025Sonendo Endotherapy SystemSonendo, Inc. · 20131cites it
  • K211995Sonendo Filling Material 5CSonendo, Inc. · 20211cites it
  • K143448Sonendo GentleWave SystemSonendo, Inc. · 20151cites it

What has FDA decided for it lately?

  • K211995Sonendo Filling Material 5CSonendo, Inc. · 2021
  • K203302GentleWave XSonendo, Inc. · 2021
  • K190359Sonendo GentleWave SystemSonendo, Inc. · 20193 recalls
  • K181922Sonendo Material ASonendo, Inc. · 2018
  • K160905Sonendo GentleWave SystemSonendo, Inc. · 2016
  • K153157Sonendo Gentle Wave SystemSonendo, Inc. · 2016
  • K143448Sonendo GentleWave SystemSonendo, Inc. · 2015
  • K133752Sonendo Omniclean Endotherpay System Console, Sonendo Omniclean Molar Procedure KitSonendo, Inc. · 2014

All 9 as Sonendo, Inc. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K190359GentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02Oct 14, 2022Class II
  • K190359GentleWave System Posterior CleanFlow Procedure Instrument with Matrices (Single) REF…Oct 14, 2022Class II
  • K190359Gentlewave Ref: FG-002-0001Oct 23, 2019Class II