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FDA 510(k)

Sonendo Filling Material 5C

K-Number: K211995 · 2021-08-27

ApplicantSonendo, Inc.
Decision Date2021-08-27
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Sonendo Filling Material 5C is the device name listed in this FDA 510(k) record. The listed applicant is Sonendo, Inc.. It received FDA 510(k) clearance on 2021-08-27 under 510(k) 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. The listed applicant is Sonendo, Inc.. The 510(k) number is K211995.

When did Sonendo Filling Material 5C receive FDA 510(k) clearance?

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

Who is the listed applicant for Sonendo Filling Material 5C?

The FDA 510(k) record lists Sonendo, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Sonendo, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K203302GentleWave XK190359Sonendo GentleWave SystemK181922Sonendo Material AK160905Sonendo GentleWave SystemK153157Sonendo Gentle Wave System

Related Devices (Code: KIF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261415Injectable Root Canal Sealer (KP-Root SP)Guilin Kevin Peter Technology Co., Ltd.K253167Any-PasteMediclus Co., Ltd.K252890ZenSeal ProKerr CorporationK251465Root canal repair materials (nRoot BP)Enpuno Biotechnology Co., Ltd.K252285Well-Root PTVericom Co., Ltd.K251884One-Fil Putty InjectableMediclus Co., Ltd.

Official Source

View on FDA Database →

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

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