FDA 510(k)

Sonendo Material A

K-Number: K181922 · 2018-10-22

Decision Date2018-10-22

Product CodeKIF

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Sonendo Material A is a medical device manufactured by Sonendo, Inc.. It received FDA 510(k) clearance on 2018-10-22 under approval number K181922. The device is classified under product code KIF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sonendo Material A?

Sonendo Material A is a medical device that received FDA 510(k) clearance on 2018-10-22. It is manufactured by Sonendo, Inc.. The 510(k) number is K181922.

When was Sonendo Material A approved by the FDA?

Sonendo Material A received FDA 510(k) clearance on 2018-10-22, under approval number K181922.

What company makes Sonendo Material A?

Sonendo Material A is manufactured by Sonendo, Inc..

What is the FDA product code for Sonendo Material A?

The FDA product code for Sonendo Material A is KIF.

Other Devices by Sonendo, Inc.

K160905Sonendo GentleWave System K153157Sonendo Gentle Wave System K190359Sonendo GentleWave System K211995Sonendo Filling Material 5C K203302GentleWave X

Related Devices (Code: KIF)

K161239MTA2.2 MATERIALAvalon Biomed, Inc. K151047MTA Repair HPAngelus Industria DE Productos Odontologicos K153067Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT XpressSybron Dental Specialties K152956Pulp Canal Sealer, Pulp Canal Sealer EWTSybron Dental Specialties K152959Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringesSybron Dental Specialties K170950Well-Root STVericom Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.