The Sonendo Filling Material 5C is a two-part filling material developed for permanent root canal filling. It is a water-soluble acrylate which is radiopaque and hardens with a chemical curing system. The Sonendo Filling Material 5C is packaged in plastic syringes with a syringe mixer and a dispensing tip. The syringe and dispensing tips are the only patient contacting devices packaged with the Sonendo Filling Material 5C and are commercially available.

AI/ML Overview

Based on the provided text, the device in question is a dental root canal filling material, and the provided document is an FDA 510(k) summary for its clearance. This document type focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving a medical device's performance through a clinical comparative effectiveness study against specific acceptance criteria like an AI algorithm would.

Therefore, the requested information regarding acceptance criteria, sample sizes, expert ground truth establishment, adjudication methods, multi-reader multi-case studies, standalone performance, and training set details cannot be fully provided from this document. This document specifies that no human clinical testing was conducted to support substantial equivalence.

However, I can extract the relevant performance data that was conducted, which focuses on device properties compared to industry standards and the predicate device.

Here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

For a root canal filling material, performance is evaluated based on physical and chemical properties as defined by ISO standards, rather than diagnostic accuracy metrics. The "acceptance criteria" are implied by the ISO standard requirements, and "device performance" is the measured value for the Sonendo Filling Material 5C compared to the predicate and the standard.

Element (Acceptance Criteria per ISO 6876:2012)	Sonendo Filling Material 5C (Subject Device)	Predicate Device (EndoREZ Dual Cure)	Comparison / Meets Criteria?
Flow (≥ 17mm)	33.45 mm	17.31 mm	Passed ISO 6876 test requirements
Working Time (implied by predicate & standard)	32.98 mm	17.38 mm	Passed ISO 6876 test requirements
Setting Time (Between 1 - 24 hours)	60 minutes, 7 seconds	25 minutes, 46 seconds	Passed ISO 6876 test requirements
Film Thickness (≤ 50 μm)	5 μm	5 μm	Passed ISO 6876 test requirements
Solubility & Disintegration (≤ 3.0% by mass; No Disintegration)	2.03% (No disintegration)	0.77% (No disintegration)	Passed ISO 6876 test requirements
Radio-opacity (≥ 3 mm of Aluminum)	3.10 mm Al	6.6 mm Al	Passed ISO 6876 test requirements

Note: The "Working Time" and "Setting Time" acceptance criteria are stated as "Passed ISO 6876 test requirements" rather than specific numeric thresholds for the subject device.

2. Sample sizes used for the test set and the data provenance

Test Set Sample Size: Not explicitly stated in terms of number of "samples" for each test. The ISO testing involves specific laboratory procedures using test specimens, but the quantity of these specimens is not detailed.
Data Provenance: The tests were conducted to comply with ISO standards. The location of the testing is not specified, but this is a U.S. FDA submission. These are laboratory/benchtop tests, not clinical data from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. For this type of device (root canal filling material) and the testing performed (physical/chemical properties per ISO standards), human expert "ground truth" as you would define for an AI diagnostic algorithm is not relevant. The "ground truth" is the objective measurement of the material's properties according to the specified ISO standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This concept relates to reconciling discrepancies in human expert interpretations, which is not part of the ISO standard physical/chemical testing for a dental material.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. The document explicitly states: "No human clinical testing was conducted to support substantial equivalence." An MRMC study is a clinical study involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is a physical dental material, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for the performance data presented is based on measurements derived from standardized laboratory tests according to ISO 6876:2012, such as flow, setting time, film thickness, solubility, and radio-opacity. Biocompatibility was assessed against ISO 10993 standards.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device; it does not have a "training set."

9. How the ground truth for the training set was established

Not applicable. As above, no training set.

Summary

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August 27, 2021

Sonendo, Inc. Steve Ziemba Vice President, Regulatory Affairs & Quality Assurance 26061 Merit Circle, Suite 102 Laguna Hills, California 92653

Re: K211995

Trade/Device Name: Sonendo Filling Material 5C Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: Class II Product Code: KIF Dated: June 24, 2021 Received: June 28, 2021

Dear Steve Ziemba:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K211995

Device Name Sonendo Filling Material 5C

Indications for Use (Describe)

Sonendo Filling Material 5C is intended for permanent obturation of the root canal following root canal treatment.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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K211995 510(k) Summary

1. Submitter:
  Sonendo, Inc. 26061 Merit Circle, Suite 102 Laguna Hills, California 92653

Contact Person:	Steven L. Ziémba
Telephone Number:	(949) 667-8151
Fax Number:	(949) 305-5201

June 24, 2021 Date Prepared:

1. Device:

Name of Device:	Sonendo Filling Material 5C
Common Name:	Root Canal Filling Resin
Classification Name:	Root Canal Filling Resin, per 21 CFR § 872.3820
Device Class:	II
Product Code:	KIF

1. Predicate Device:

Primary Predicate:	EndoREZ Dual Cure, Ultradent Products, Inc., K071106, ProductCode KIF
Reference Device:	Pulp Canal Sealer EWT, Sybron Dental Specialties, Inc.,K152956, Product Code KIF

4. Device Description

1. Statement of Intended Use:
  The Sonendo Filling Material 5C is intended for permanent obturation of the root canal following root canal treatment.
1. Summary of Technological Characteristics with the Predicate Device
  The technological characteristics of the subject Sonendo Filling Material 5C are similar to the predicate device, EndoREZ Dual Cure (K071106). There are no substantial technical or functional differences between the Sonendo Filling Material 5C and the predicate device in

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terms of chemical composition, function and intended use. Both are root canal filling resins consisting of a catalyst and base packaged in individual syringes. See Table 1 below for technological characteristics and comparisons of the root canal filling resins.

Element	Sonendo FillingMaterial 5C(Subject Device)	EndoREZ Dual Cure(Predicate Device)	Comparison
Company	Sonendo, Inc.	Ultradent Products, Inc.	N/A
510(k)	K211995	K071106	N/A
Indications for Use	The Sonendo FillingMaterial 5C is intendedfor permanentobturation of the rootcanal following rootcanal treatment.	EndoRez is designed to beused with EndoREZ Pointsand/or gutta percha for thefilling of cleaned and shapedroot canals. EndoREZ, inconjunction with a master coneand accessory cones (asneeded), provides optimumsealing. Although EndoREZPoints are recommended,EndoREZ may be used with allconventional endodonticobturation techniques.	Indicated for samepurpose - filling of rootcanals.
Target Users	Dental Professionalstrained in endodontics.	Dental Professionals trained inendodontics.	Same
Basic ChemicalComposition	Poly(ethylene glycol)diacrylate, water, 5-acrylamido-2,4,6-triiodoisophthalic acid,triethanolamine, sodiumhydroxide, potassiumpersulfate	Diurethane dimethacrylate,triethylene glycoldimethacrylate,organophosphine oxide,benzoyl peroxide, radiopaqueagent	Similar - The predicatedevice employs acrylatemonomers catalyzed bya peroxide as does thesubject device.
MaterialCompatibility	Biocompatibility profileis similar to currentlymarketed referencedental filling materialand demonstrates noincreased risk withrespect to long-termbiological safety.	Meets BiocompatibilityRequirements of ISO 10993-1	Same
Element	Sonendo FillingMaterial 5C(Subject Device)	EndoREZ Dual Cure(Predicate Device)	Comparison
Flow(ISO 6876: 2012)	33.45 mm≥ 17mm	17.31 mm≥ 17mm	Same - Passed ISO6876 test requirements
Working Time(ISO 6876: 2012)	32.98 mm≥ 17mm	17.38 mm≥ 17mm	Same - Passed ISO6876 test requirements
Setting Time(ISO 6876: 2012)	60 minutes, 7 secondsClaim of 1 - 24 hoursBetween 1 - 24 hours	25 minutes, 46 secondsClaim of 30 minutesNo more than 10% longer	Same - Passed ISO6876 test requirements
Film Thickness(ISO 6876: 2012)	5 μm≤ 50 μm	5 μm≤ 50 μm	Same - Passed ISO6876 test requirements
Solubility &Disintegration(ISO 6876:2012)	2.03%No disintegration≤ 3.0% by massNo Disintegration	0.77%No disintegration≤ 3.0% by massNo Disintegration	Same - Passed ISO6876 test requirements
Radio-opacity(ISO 6876:2012)	3.10 mm Al≥ 3 mm of Aluminum	6.6 mm Al≥ 3 mm of Aluminum	Same - Passed ISO6876 test requirements

Table 1: Comparison of Subject and Predicate Devices

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7. Performance Data

Biocompatibility Testing

The biocompatibility evaluation for the Sonendo Filling Material 5C was conducted in accordance with ISO 7405:2018 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry, Annex A, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process" as recognized by FDA. The biocompatibility testing included the following tests:

1. Cytotoxicity
1. Sensitization
1. Intracutaneous Reactivity

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1. Acute Systemic Toxicity
1. Subacute Toxicity
1. Genotoxicity
1. Intramuscular Implantation
1. Material mediated pyrogenicity

The biocompatibility testing conducted demonstrates adequate biocompatibility for the Sonendo Filling Material 5C.

ISO 6876 Testing

Testing according to ISO 6876:2012 Dentistry - Root canal sealing materials was performed on the Sonendo Filling Material 5C and as compared to the predicate device, it was substantially equivalent to the device and met the physical/mechanical properties of the standard.

Clinical Studies

No human clinical testing was conducted to support substantial equivalence.

8. Conclusion as to Substantial Equivalence

The similarities in chemical composition, function and intended use of the Sonendo Filling Material 5C with the legally marketed predicate device, EndoREZ Dual Cure (K071106), support substantial equivalence.

Regulation Number and Section

§ 872.3820 Root canal filling resin.

(a)
Identification. A root canal filling resin is a device composed of material, such as methylmethacrylate, intended for use during endodontic therapy to fill the root canal of a tooth.(b)
Classification. (1) Class II if chloroform is not used as an ingredient in the device.(2) Class III if chloroform is used as an ingredient in the device.
(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976. Any other root canal filling resin shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.