Sonendo Filling Material 5C

K211995 · Sonendo, Inc. · KIF · Aug 27, 2021 · Dental

Device Facts

• Record ID: K211995
• Device Name: Sonendo Filling Material 5C
• Applicant: Sonendo, Inc.
• Product Code: KIF · Dental
• Decision Date: Aug 27, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Sonendo Filling Material 5C is a two-part, water-soluble, radiopaque acrylate resin used for permanent root canal obturation. The material is supplied in plastic syringes with a mixer and dispensing tip. It utilizes a chemical curing system to harden within the root canal. The device is intended for use by dental professionals trained in endodontics within a clinical setting. By providing a permanent seal, the material supports the success of root canal therapy. The device is applied directly into the canal; the clinician manages the placement and setting process. No electronic or software components are involved.

Clinical Evidence

No clinical data was provided. Substantial equivalence is supported by bench testing, including biocompatibility testing per ISO 10993-1 and ISO 7405:2018 (cytotoxicity, sensitization, reactivity, toxicity, genotoxicity, implantation, pyrogenicity) and physical/mechanical performance testing per ISO 6876:2012 (flow, working time, setting time, film thickness, solubility, radio-opacity).

Technological Characteristics

Two-part root canal filling resin; chemical curing system. Composition: Poly(ethylene glycol) diacrylate, water, 5-acrylamido-2,4,6-triiodoisophthalic acid, triethanolamine, sodium hydroxide, potassium persulfate. Form factor: Plastic syringes with mixer and dispensing tip. Performance standards: ISO 6876:2012 (flow, working time, setting time, film thickness, solubility, radio-opacity). Biocompatibility standards: ISO 10993-1, ISO 7405:2018.

Indications for Use

Indicated for permanent obturation of the root canal following root canal treatment in patients undergoing endodontic procedures.

Regulatory Classification

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.

Predicate Devices

• EndoREZ Dual Cure (K071106)

Reference Devices

• Pulp Canal Sealer EWT (K152956)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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: | [phone] |
| Fax Number: | [phone] |

June 24, 2021 Date Prepared:

- 2. 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 |

- 3. Predicate Device:

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

#### 4. Device Description

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.

- 5. Statement of Intended Use:
The Sonendo Filling Material 5C is intended for permanent obturation of the root canal following root canal treatment.

- 6. 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 Filling<br>Material 5C<br>(Subject Device) | EndoREZ Dual Cure<br>(Predicate Device) | Comparison |
|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Company | Sonendo, Inc. | Ultradent Products, Inc. | N/A |
| 510(k) | K211995 | K071106 | N/A |
| Indications for Use | The Sonendo Filling<br>Material 5C is intended<br>for permanent<br>obturation of the root<br>canal following root<br>canal treatment. | EndoRez is designed to be<br>used with EndoREZ Points<br>and/or gutta percha for the<br>filling of cleaned and shaped<br>root canals. EndoREZ, in<br>conjunction with a master cone<br>and accessory cones (as<br>needed), provides optimum<br>sealing. Although EndoREZ<br>Points are recommended,<br>EndoREZ may be used with all<br>conventional endodontic<br>obturation techniques. | Indicated for same<br>purpose - filling of root<br>canals. |
| Target Users | Dental Professionals<br>trained in endodontics. | Dental Professionals trained in<br>endodontics. | Same |
| Basic Chemical<br>Composition | Poly(ethylene glycol)<br>diacrylate, water, 5-<br>acrylamido-2,4,6-<br>triiodoisophthalic acid,<br>triethanolamine, sodium<br>hydroxide, potassium<br>persulfate | Diurethane dimethacrylate,<br>triethylene glycol<br>dimethacrylate,<br>organophosphine oxide,<br>benzoyl peroxide, radiopaque<br>agent | Similar - The predicate<br>device employs acrylate<br>monomers catalyzed by<br>a peroxide as does the<br>subject device. |
| Material<br>Compatibility | Biocompatibility profile<br>is similar to currently<br>marketed reference<br>dental filling material<br>and demonstrates no<br>increased risk with<br>respect to long-term<br>biological safety. | Meets Biocompatibility<br>Requirements of ISO 10993-1 | Same |
| Element | Sonendo Filling<br>Material 5C<br>(Subject Device) | EndoREZ Dual Cure<br>(Predicate Device) | Comparison |
| Flow<br>(ISO 6876: 2012) | 33.45 mm<br>≥ 17mm | 17.31 mm<br>≥ 17mm | Same - Passed ISO<br>6876 test requirements |
| Working Time<br>(ISO 6876: 2012) | 32.98 mm<br>≥ 17mm | 17.38 mm<br>≥ 17mm | Same - Passed ISO<br>6876 test requirements |
| Setting Time<br>(ISO 6876: 2012) | 60 minutes, 7 seconds<br>Claim of 1 - 24 hours<br>Between 1 - 24 hours | 25 minutes, 46 seconds<br>Claim of 30 minutes<br>No more than 10% longer | Same - Passed ISO<br>6876 test requirements |
| Film Thickness<br>(ISO 6876: 2012) | 5 μm<br>≤ 50 μm | 5 μm<br>≤ 50 μm | Same - Passed ISO<br>6876 test requirements |
| Solubility &<br>Disintegration<br>(ISO 6876:2012) | 2.03%<br>No disintegration<br>≤ 3.0% by mass<br>No Disintegration | 0.77%<br>No disintegration<br>≤ 3.0% by mass<br>No Disintegration | Same - Passed ISO<br>6876 test requirements |
| Radio-opacity<br>(ISO 6876:2012) | 3.10 mm Al<br>≥ 3 mm of Aluminum | 6.6 mm Al<br>≥ 3 mm of Aluminum | Same - Passed ISO<br>6876 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
- 2. Sensitization
- 3. Intracutaneous Reactivity

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- 4. Acute Systemic Toxicity
- 5. Subacute Toxicity
- 6. Genotoxicity
- 7. Intramuscular Implantation
- 8. 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.