Sonendo Material A

K181922 · Sonendo, Inc. · KIF · Oct 22, 2018 · Dental

Device Facts

• Record ID: K181922
• Device Name: Sonendo Material A
• Applicant: Sonendo, Inc.
• Product Code: KIF · Dental
• Decision Date: Oct 22, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Permanent obturation of the root canal following root canal treatment.

Device Story

Sonendo Material A is a single-component, injectable paste used for permanent root canal obturation. It consists of alginate and a calcium-containing compound that crosslinks upon water exposure to form an insoluble polymer. The material is radiopaque and can be applied with or without a root canal point. It is supplied in pre-loaded syringes with single-use tips or single-dose capsules. Used by dentists in a clinical setting, the material fills the root canal space to provide a permanent seal following treatment. The device benefits patients by providing a biocompatible, radiopaque barrier that supports successful endodontic outcomes.

Clinical Evidence

Bench testing only. Performance evaluated against ISO 6876 standards for flow, working time, setting time, film thickness, solubility, and radiopacity. Biocompatibility testing conducted per ISO 10993-1 confirmed the material is non-mutagenic, non-cytotoxic, non-allergenic, and well-tolerated by subcutaneous tissue.

Technological Characteristics

Single-component injectable paste. Composition: sodium alginate, glycerol, calcium sulfate, calcium tungstate, sodium pyrophosphate, polysorbate 60, zinc oxide, fumed silica, ytterbium fluoride, barium borosilicate. Crosslinking mechanism: water-activated polymerization. Packaging: pre-loaded syringe or single-dose capsule. Non-sterile. Standards: ISO 6876 (physical properties), ISO 10993-1 (biocompatibility).

Indications for Use

Indicated for permanent obturation of the root canal following root canal treatment in patients requiring endodontic therapy.

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

• iRoot SP Root Canal Sealer (K080917)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health & Human Services logo on the left and the FDA acronym followed by the full name of the agency, "U.S. Food & Drug Administration," on the right. The FDA acronym and the agency's name are in blue.

October 22, 2018

Sonendo, Inc. Eric Simon Director of Regulatory Affairs and Quality Assurance, Sonendo, Inc. 26061 Merit Circle, Suite 102 Laguna Hills, California 92653

## Re: K181922

Trade/Device Name: Sonendo Material A Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: Class II Product Code: KIF Dated: July 17, 2018 Received: July 18, 2018

### Dear Eric Simon:

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Mary S. Runner -S3

For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration | Form Approved: OMB No. 0910-0120<br>Expiration Date: 06/30/2020<br>See PRA Statement below. |
|-------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
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**Indications for Use**

| 510(k) Number (if known) | K181922 |
|--------------------------------|------------------------------------------------------------------------|
| Device Name | Sonendo Material A |
| Indications for Use (Describe) | Permanent obturation of the root canal following root canal treatment. |

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| <label><input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

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## 7.0 510(k) Summary

This 510(k) summary information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

| APPLICANT: | Sonendo, Inc. |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------|
| DATE PREPARED: | July 17, 2018 |
| CONTACT PERSON: | Eric Simon<br>26061 Merit Circle, Suite 102<br>Laguna Hills, CA 92653<br>Phone: [phone]<br>Fax: [phone] |
| TRADE NAME: | Sonendo Material A |
| COMMON NAME: | Resin, Root Canal Filling |
| CLASSIFICATION NAME: | Root canal filling resin |
| DEVICE CLASSIFICATION: | Class 2, per 21 CFR 872.3820 |
| REVIEWING PANEL: | Dental |
| ESTABLISHMENT REGISTRATION NO. | 3010817521 |
| PRODUCT CODE | KIF |

PREDICATE DEVICES: iRoot SP Root Canal Sealer (K080917)

#### Substantially Equivalent To:

The Sonendo Material A is substantially equivalent in intended use, principle of operation and technological characteristics to the iRoot Canal Sealer (K080917).

#### Description of the Device Subject to Premarket Notification:

Sonendo Material A is a single component injectable paste material intended for permanent obturation of the root canal following root canal treatment. The device is comprised of alginate and a calcium containing compound which crosslinks in the presence of water to form an insoluble polymer. The placement into the root canal can be accomplished with or without the use a root canal point. The material is radiopaque and has physical properties such that it is suitable for root canal obturation. The material is packaged in either a syringe with single use dispensing tips or in a single dose capsule.

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#### Indication for Use:

Permanent obturation of the root canal following root canal treatment.

#### Device Comparison Table:

| | Sonendo<br>Material A<br>(Subject<br>Device) | iRoot SP Root Canal<br>Sealer (Predicate<br>Device - K080917) | Discussion/Justification of<br>Differences |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication<br>for Use | Permanent<br>obturation of the<br>root canal<br>following root<br>canal treatment | Permanent obturation of the<br>root canal following vital<br>pulp-extirpation<br><br>Permanent obturation of the<br>root canal following<br>removal of infected or<br>necrotic pulp and placement<br>of intracanal dressings | Equivalent |
| Basic<br>Chemical<br>Composition | Sodium alginate,<br>glycerol, calcium<br>sulfate, calcium<br>tungstate, sodium<br>pyrophosphate,<br>polysorbate 60,<br>zinc oxide,<br>fumed silica,<br>ytterbium<br>fluoride, barium<br>borosilicate | Zirconium oxide, dicalcium<br>silicate, calcium hydroxide,<br>calcium phosphate<br>monobasic, filler, thickening<br>agent | iRoot SP Root Canal Sealer was<br>identified as the predicate device due to<br>the subject device having similar<br>materials and delivery form (i.e.<br>premixed ready-to-use injectable paste)<br>to the predicate. The predicate device is<br>composed of lubricants, a radiopaque<br>agent and thickening agents as does the<br>subject device. Results of bench and<br>biocompatibility testing completed in<br>alignment with ISO 6876 and ISO<br>10993-1, respectively demonstrate that<br>any material differences between the<br>subject device and predicate device do<br>not raise any new questions as to safety<br>and effectiveness. Therefore, it is<br>concluded that Sonendo Material A is<br>substantially equivalent to the predicate<br>device. |
| Standard | ISO 6876<br>ISO 10993-1 | ISO 6876<br>ISO 10993-1 | Equivalent |
| Treatment<br>Site | Root canal | Root Canal | Equivalent |
| Sterile | Non-sterile | Non-sterile | Equivalent |
| Packaging | Pre-loaded<br>syringe | Pre-loaded syringe | Equivalent |

## Performance Data:

Sonendo Material A has undergone extensive bench testing to provide evidence that its physical-chemical properties are substantially equivalent to iRoot SP Root Canal Sealer. Bench tests include: flow, working time, setting time, film thickness, solubility, and radiopacity in alignment with ISO 6876.

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Biocompatibility test results demonstrate that Sonendo Material A is non-mutagenic, non-cytotoxic, does not cause an allergenic potential after multiple uses and has a good tolerance by subcutaneous tissue.

#### Conclusion:

Sonendo Material A and its predicate device have the same intended use, provides similar chemical, physical and biocompatible properties, and comparable performance specifications to iRoot SP Root Canal Sealer. The subject and predicate devices are packaged in similar materials and utilize similar methods of application. Any differences in the technological characteristics do not raise new issues of safety or effectiveness.