Sonendo Filling Material 5C— 510(k) K211995

Substantially Equivalent

Sonendo, Inc.

FDA 510(k) clearance K211995 for Sonendo Filling Material 5C, Substantially Equivalent on 2021-08-27. Applicant: Sonendo, Inc.. Device class: 2.

Clearance details

Applicant: Sonendo, Inc.
Product code: Code KIF
Device class: Class 2
Regulation: 21 CFR 872.3820
Advisory panel: Dental
Date received: 2021-06-28
Decision date: 2021-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Laguna Hills, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KIF

K262050 — Vioseal X2026-09-11
K253909 — NeoPEX Pre-Mixed Obturation Paste2026-09-04
K261514 — Calcium Hydroxide Temporary Filling Material (KP-Cal)2026-08-25
K261415 — Injectable Root Canal Sealer (KP-Root SP)2026-06-29
K253167 — Any-Paste2026-01-12

More clearances from Sonendo, Inc.

K203302 — GentleWave X2021-02-05
K190359 — Sonendo GentleWave System2019-03-16
K181922 — Sonendo Material A2018-10-22
K160905 — Sonendo GentleWave System2016-06-03
K153157 — Sonendo Gentle Wave System2016-01-29

Data sourced from openFDA. This site is unofficial and independent of the FDA.