Cleared Traditional

Sonendo Filling Material 5C (K211995) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K211995 · Sonendo, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2021
Decision
60d
Days
Class 2
Risk

K211995 is an FDA 510(k) clearance for the Sonendo Filling Material 5C. Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by Sonendo, Inc. (Laguna Hills, US). The FDA issued a Cleared decision on August 27, 2021 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3820 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sonendo, Inc. devices

Submission Details

510(k) Number K211995 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2021
Decision Date August 27, 2021
Days to Decision 60 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 127d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KIF Resin, Root Canal Filling
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3820
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - KIF Resin, Root Canal Filling

All 58
Devices cleared under the same product code (KIF) and FDA review panel - the closest regulatory comparables to K211995.
Injectable Root Canal Bioceramic Sealer
K212983 · Beijing C-Root Dental Medical Devices Co., Ltd. · Dec 2021
UltraCal XS
K211905 · Ultradent Products, Inc. · Oct 2021
BioRoot Flow 0.5g, BioRoot Flow 2g
K212283 · Septodont · Sep 2021
White Endoseal MTA
K212229 · Maruchi · Aug 2021
Biodentine XP 500, Biodentine XP 200
K211799 · Septodont · Aug 2021
Metapaste Plus
K210904 · Meta Biomed Co., Ltd. · Jun 2021