Sonendo Material A

Resin, Root Canal Filling

Sonendo, Inc.

The following data is part of a premarket notification filed by Sonendo, Inc. with the FDA for Sonendo Material A.

Pre-market Notification Details

Device IDK181922
510k NumberK181922
Device Name:Sonendo Material A
ClassificationResin, Root Canal Filling
Applicant Sonendo, Inc. 26061 Merit Circle, Suite 102 Laguna Hills,  CA  92653
ContactEric Simon
CorrespondentEric Simon
Sonendo, Inc. 26061 Merit Circle, Suite 102 Laguna Hills,  CA  92653
Product CodeKIF  
CFR Regulation Number872.3820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-07-18
Decision Date2018-10-22
Summary:summary

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