K Number

Device Name

GentleWave X

Manufacturer

Sonendo, Inc

Date Cleared

2021-02-05

(88 days)

Product Code

ELC

Regulation Number

872.4850

Intended Use

The Sonendo Gentle Wave X System is intended to prepare, clean, and irrigate teeth indicated for root canal therapy. When used with the Sonendo GentleWave Molar Procedure Instrument or Molar CrossFire™ Procedure Instrument, the System is indicated for 1st and 2nd molar teeth. When used with the Sonendo Gentle Wave Anterior/Premolar Procedure Instrument, the System is indicated for anterior and premolar teeth. When used with the Sonendo Gentle Wave Premolar CrossFire™ Procedure Instrument, the system is indicated for premolar teeth.

Device Description

The Sonendo GentleWave X System is a medical device intended to prepare, clean and irrigate root canals. The Sonendo GentleWave X System is comprised of a Console, and disposable single-use Handpieces and accessories. The Handpiece is offered for molar, anterior and premolar treatments. A Molar Handpiece (original or CrossFire™ model) is intended to be used on 1st and 2nd molar teeth. An Anterior/Premolar (APM) Handpiece is intended to be used on anterior and pre-molar teeth and CrossFire™ Premolar Handpiece is intended for pre-molar teeth only. The Sonendo GentleWave X System delivers a stream of treatment fluids into the pulp chamber of the tooth. The treatment fluids delivered to the tooth are 3% Sodium Hypochlorite (NaOCl) solution and an 8% Ethylenediaminetetraacetic acid (EDTA) utilized in traditional endodontic treatments.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K160905

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The provided text describes a system for root canal therapy that uses fluid delivery and does not mention any AI or ML components or capabilities.

Therapeutic

Yes
The device is intended to prepare, clean, and irrigate teeth for root canal therapy using treatment fluids, which is a therapeutic intervention.

Diagnostic

The device description clearly states its purpose is to "prepare, clean and irrigate root canals" and "deliver a stream of treatment fluids into the pulp chamber of the tooth." There is no mention of analysis, detection, or diagnosis of any condition.

SaMD (Software as a Medical Device)

The device description explicitly states that the system is comprised of a Console, and disposable single-use Handpieces and accessories, indicating the presence of hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, the Sonendo GentleWave X System is not an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The intended use is to "prepare, clean, and irrigate teeth indicated for root canal therapy." This describes a therapeutic procedure performed directly on the patient's teeth.
Device Description: The device description details a system that delivers fluids into the tooth's pulp chamber for cleaning and irrigation. This is a treatment method, not a diagnostic test performed on a sample taken from the body.
Lack of Diagnostic Activity: There is no mention of analyzing samples (like blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition. The device's function is purely procedural.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Sonendo GentleWave X System does not fit this definition.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

ELC

Device Description

The Sonendo GentleWave X System delivers a stream of treatment fluids into the pulp chamber of the tooth. The treatment fluids delivered to the tooth are 3% Sodium Hypochlorite (NaOCl) solution and an 8% Ethylenediaminetetraacetic acid (EDTA) utilized in traditional endodontic treatments.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

teeth, root canal, pulp chamber

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-Clinical Performance Testing:

Performance Verification
- Thermal test
- Cavitation test
- Hydroacoustic test
- Cleaning test
- Apical pressure test
- Apical extrusion test
Human Factor Evaluation per the FDA Guidance Document "Applying Human Factors and Usability Engineering to Medical Devices"
Software Validation for moderate level of concern per the FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"
Biocompatibility
- Cytotoxicity, sensitization, irritation, material mediated pyrogenicity, and acute systemic toxicity
Electromagnetic Compliance and Electrical Safety

All necessary performance testing has been conducted on the Sonendo GentleWave System X to assure substantial equivalence to the predicate devices and to demonstrate the device performs as intended.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K160905

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 872.4850 Ultrasonic scaler.

(a)
Identification. An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.(b)
Classification. Class II.

Summary

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 5, 2021

Sonendo, Inc Lyle VerPlanck Director of Regulatory Affairs & Quality Assurance 26061 Merit Circle, Suite 102 Laguna Hills, California 92653

Re: K203302

Trade/Device Name: GentleWave X Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: Class II Product Code: ELC Dated: November 6, 2020 Received: November 9, 2020

Dear Lyle VerPlanck:

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

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,

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

Enclosure

Confidential

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

Device Name GentleWave X

Indications for Use (Describe)

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Summary

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

General Information
510(k) number:	K203302
Date Summary Prepared:	February 3, 2021
Submitted by:	Sonendo, Inc.
22061 Merit Circle, Suite 102
Laguna Hills, CA 92653
Establishment Registration
Number:	3010817521
Contact Person:	Lyle VerPlanck
Director of Regulatory Affairs & Quality Assurance
Phone: (949) 667-7260
FAX: (949) 305-5201
E-mail: lverplanck@sonendo.com
Reason for Premarket
Notification:	New model of GentleWave System
Trade Name:	GentleWave X
Regulation Name:	Ultrasonic Scaler
Review Panel :	Dental
Classification Regulation:	872.4850
Product Code:	ELC
Regulatory Class:	Class II
Predicate Device:	Sonendo GentleWave System via K160905

Device Description

The design of this device incorporated the consensus standards listed in Table 1.

| Recognition
Number | Standard
Designation
Number | Standard Title |
|-----------------------|-----------------------------------|------------------------------------------------------------------------------------------------------------------|
| 2-258 | ISO 10993-1 | Biological evaluation of medical devices - Part 1:
Evaluation and testing within a risk management
process |
| 2-245 | ISO 10993-5 | Biological evaluation of medical devices - Part 5: Tests
for in vitro cytotoxicity |
| 2-174 | ISO 10993-10 | Biological evaluation of medical devices - Part 10: Tests
for irritation and skin sensitization |
| 2-255 | ISO 10993-11 | Biological evaluation of medical devices - Part 11: Tests
for systemic toxicity |
| 19-4 | IEC 60601-1 | Medical electrical equipment - Part 1: General
requirements for basic safety and essential performance |
| 19-8 | IEC 60601-1-2 | Medical electrical equipment - Part 1-2: General
requirements for basic safety and essential perform |
| 4-262 | IEC 80601-2-60 | Particular requirements for the basic safety and essential
performance of dental equipment |
| 5-114 | IEC 62366-1 | Medical devices - Part 1: Application of usability
engineering to medical devices |

Table 1 - Recognized Consensus Standards

Indications for Use

The Sonendo GentleWave X System is intended to prepare, clean, and irrigate teeth indicated for root canal therapy. When used with the Sonendo GentleWave Molar Procedure Instrument orMolar CrossFire™ Procedure Instrument, the System is indicated for 1st and 2nd molar teeth. When used with the Sonendo GentleWave Anterior/Premolar Procedure Instrument, the System is indicated for anterior and premolar teeth. When used with the Sonendo GentleWave Premolar CrossFire™ Procedure Instrument, the system is indicated for premolar teeth.

Substantial Equivalence Summary and Discussion

The table below includes a comparison between the new device and the predicate device:

Characteristic	Predicate Device	Proposed Device
510(k) Clearance #	K160905	TBD
Console Model	GentleWave®	GentleWave™ X
Indications for Use	The Sonendo GentleWave System
is intended to prepare, clean, and
irrigate teeth indicated for root
canal therapy. When used with
the Sonendo GentleWave Molar
Handpiece, the System is indicated
for 1st and 2nd molar teeth.
When used with the Sonendo
GentleWave Anterior/Premolar
Handpiece, the System is indicated
for anterior and premolar teeth.	The Sonendo GentleWave X System
is intended to prepare, clean, and
irrigate teeth indicated for root canal
therapy. When used with the
Sonendo GentleWave Molar
Procedure Instrument or Molar
CrossFire™ Procedure Instrument,
the System is indicated for 1st and
2nd molar teeth. When used with
the Sonendo GentleWave
Anterior/Premolar Procedure
Instrument, the System is indicated
for anterior and premolar teeth.
When used with the Sonendo
GentleWave Premolar CrossFire™
Procedure Instrument, the system is
indicated for premolar teeth.
New Contraindications	---	Primary dentition
Patients with sensitivity to NaOCl
and / or EDTA
Function	Preparation, cleaning and irrigation
of root canal	Identical as predicate
Characteristic	Predicate Device	Proposed Device
Principal of Operation	Generation of hydroacoustic waves
and fluid motion via application of
sonic energy	Identical as predicate
Treatment Site	Root Canal	Identical as predicate
Components	Control Unit
Irrigation reservoirs
Foot pedal
Handpiece
Hand piece Accessories	Identical as predicate
Duration of treatment
application	7 minutes or less	Identical as predicate
Treatment fluid
Concentration	Fixed	Identical as predicate
Fluid Containers	1 × 500 mL NaOCl irrigation
solution
1 × 250 mL EDTA irrigation
solution
1 × 2000 mL distilled water for
irrigation	1 × 1360 mL NaOCl irrigation
solution
1 × 540 mL EDTA irrigation
solution
1 × 2650 mL distilled water for
irrigation
Material	Medical grade material	Identical as predicate
Biocompatibility	Biocompatible per 10993	Identical as predicate
Handpiece models	Molar Handpiece (original model),
Anterior/Premolar Handpiece	Molar Handpiece (original or
CrossFire™ model ),
Anterior/Premolar Handpiece,
Premolar CrossFire™ model
Handpiece
Handpiece Sterilization	Sterile (Gamma)
Single use
Sterility Assurance Level (SAL) 10-6	Identical as predicate
Consumable Shelf Life	1 year	Identical as predicate

Table 1 - Comparison of Predicate and Proposed Devices

The proposed device has the same intended use, function, principal of operation, control mechanism, sterilization and shelf life as the predicate device. The indications for use is slightly changed to add new models of the handpiece within the scope of the predicate device indications

for use. To highlight that the use of GentleWave X system is limited to treat permanent teeth only, contraindication for primary dentition teeth is added. Furthermore, to minimize any potential adverse reaction, the device is contraindicated for use on patients with a known sensitivity to NaOCl and/ or EDTA. The new handpiece models are added to increase manufacturability and there is no change in the handpiece operating principal. The new Console model has increased capacity, with larger bottle sizes to facilitate more treatments cycles. The new model is designed to improve customer interface, product reliability and manufacturability. Performance testing is completed to show the equivalency between the proposed and predicate devices.

Non-Clinical Performance Testing

All necessary performance testing has been conducted on the Sonendo GentleWave System X to assure substantial equivalence to the predicate devices and to demonstrate the device performs as intended. The following bench testing in accordance with standards listed in Table 1 was performed and passed to support the substantial equivalence of the subject device:

Performance Verification
- Thermal test O
- Cavitation test O
- Hydroacoustic test O
- Cleaning test O
- Apical pressure test o
- Apical extrusion test o
Human Factor Evaluation per the FDA Guidance Document "Applying Human Factors and Usability ● Engineering to Medical Devices"
Software Validation for moderate level of concern per the FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"
. Biocompatibility
- Cytotoxicity, sensitization, irritation, material mediated pyrogenicity, and acute systemic 0 toxicity
Electromagnetic Compliance and Electrical Safety

Clinical Data

No clinical data is submitted in support of this Premarket Notification.

Conclusion

The Sonendo GentleWave X System is a new model of the existing Sonendo GentleWave® System. The Sonendo GentleWave X System is substantially equivalent to the Sonendo GentleWave System cleared under premarket notification K160905.