FDA 510(k)

Sonendo Filling Material 5C

K-Number: K211995 · 2021-08-27

Decision Date2021-08-27

Product CodeKIF

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Sonendo Filling Material 5C is a medical device manufactured by Sonendo, Inc.. It received FDA 510(k) clearance on 2021-08-27 under approval number K211995. 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 Filling Material 5C?

Sonendo Filling Material 5C is a medical device that received FDA 510(k) clearance on 2021-08-27. It is manufactured by Sonendo, Inc.. The 510(k) number is K211995.

When was Sonendo Filling Material 5C approved by the FDA?

Sonendo Filling Material 5C received FDA 510(k) clearance on 2021-08-27, under approval number K211995.

What company makes Sonendo Filling Material 5C?

Sonendo Filling Material 5C is manufactured by Sonendo, Inc..

What is the FDA product code for Sonendo Filling Material 5C?

The FDA product code for Sonendo Filling Material 5C is KIF.

Other Devices by Sonendo, Inc.

K160905Sonendo GentleWave System K153157Sonendo Gentle Wave System K181922Sonendo Material A K190359Sonendo GentleWave System 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.