Sonendo Filling Material 5C

Resin, Root Canal Filling

Sonendo, Inc.

The following data is part of a premarket notification filed by Sonendo, Inc. with the FDA for Sonendo Filling Material 5c.

Pre-market Notification Details

Device IDK211995
510k NumberK211995
Device Name:Sonendo Filling Material 5C
ClassificationResin, Root Canal Filling
Applicant Sonendo, Inc. 26061 Merit Circle, Suite 102 Laguna Hills,  CA  92653
ContactSteve Ziemba
CorrespondentSteve Ziemba
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 Received2021-06-28
Decision Date2021-08-27

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