SONENDO OMNICLEAN ENDOTHERPAY SYSTEM CONSOLE, SONENDO OMNICLEAN MOLAR PROCEDURE KIT

K133752 · Sonendo, Inc. · ELC · May 15, 2014 · Dental

Device Facts

• Record ID: K133752
• Device Name: SONENDO OMNICLEAN ENDOTHERPAY SYSTEM CONSOLE, SONENDO OMNICLEAN MOLAR PROCEDURE KIT
• Applicant: Sonendo, Inc.
• Product Code: ELC · Dental
• Decision Date: May 15, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Sonendo OmniClean Endotherapy System is intended to prepare, clean and irrigate 1st and 2nd molar teeth indicated for root canal therapy.

Device Story

The Sonendo OmniClean Endotherapy System is a dental device used by clinicians to prepare, clean, and irrigate root canals in 1st and 2nd molars. The system consists of a console, foot pedal, and a molar procedure kit including a handpiece. Operation involves placing the device tip inside the tooth; hydroacoustic waves and fluid motion are generated by a water stream flowing through a guide tube, which is then dispersed and deflected by the distal end plate of the tube. This process cleans the root canal using irrigation fluids (NaOCl, EDTA, or water). The device is used in a clinical setting to facilitate root canal therapy, potentially improving cleaning efficacy compared to traditional methods. The clinician controls the procedure via the console and foot pedal.

Clinical Evidence

Bench testing only. Performance testing included simulated use, EMC and electrical safety, thermal safety, hydroacoustics, apical extrusion and pressure, and cleaning efficacy. No clinical data was provided.

Technological Characteristics

System components: console, foot pedal, handpiece, irrigation reservoirs. Principle: hydroacoustic wave generation and fluid motion via distal tip deflection. Irrigation fluids: NaOCl, EDTA, water. Flow rate: 45 +/- 10 ml/min. Treatment duration: 7 minutes 45 seconds. Sterilization: not specified.

Indications for Use

Indicated for preparation, cleaning, and irrigation of 1st and 2nd molar teeth requiring root canal therapy.

Regulatory Classification

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.

Predicate Devices

• Sonendo Endotherapy System (K130025)
• EMS Piezon Master 700 (K093000)
• Sonic Air MM 1500+ (MID) (K081268)

Submission Summary (Full Text)

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510(k) Summary

#### 1. 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: | December 4, 2013 |
| CONTACT PERSON: | Dan W. Miller<br>Sonendo, Inc.<br>26061 Merit Circle, Suite 101<br>Laguna Hills, CA 92653<br>Phone: [phone] x544 |
| TRADE NAME: | Sonendo OmniClean Endotherapy System |
| COMMON NAME: | Sonic Cleaning and Irrigation System |
| CLASSIFICATION NAME: | Ultrasonic Scaler |
| DEVICE CLASSIFICATION: | Class 2, per 21 CFR 872.4850 |
| PRODUCT CODE | ELC |
| PREDICATE DEVICES: | Sonendo Endotherapy System (K130025)<br>EMS Piezon Master 700 (K093000)<br>Sonic Air MM 1500+ (MID) (K081268) |

#### Substantially Equivalent To:

The Sonendo OmniClean Endotherapy System is substantially equivalent in intended use, principle of operation and technological characteristics to the Sonendo Endotherapy System (K130025), the EMS Piezon Master 700 (K093000) and the Sonic Air MM 1500+ (MID) (K081268).

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

The Sonendo OmniClean Endotherapy System is a medical device intended to prepare, clean and irrigate 15 and 2nd molar teeth indicated for root canal therapy. The Sonendo OmniClean Endotherapy System is comprised of a Console, Foot Pedal and Molar Procedure Kit with a Handpiece.

#### Indication for Use :.

The Sonendo OmniClean Endotherapy System is intended to prepare, clean and irrigate 11 and 2nd molar teeth indicated for root canal therapy.

Page 1 of 3 Premarket Notification: K133752

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## Technical Characteristics:

The Sonendo OmniClean Endotherapy System has similar physical and technical characteristics to the predicate devices. These characteristics are tabulated below:

| Characteristics | Sonendo<br>OmniClean<br>Endotherapy<br>System (K133752) | Sonendo<br>Endotherapy<br>System (K130025) | EMS Piezon<br>Master 700<br>(K093000) | Sonic Air MM<br>1500 + (MID)<br>(K081268) |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|--------------------------------------------------------------|
| Function | Preparation,<br>cleaning and<br>irrigation of root<br>canals | Preparation,<br>cleaning and<br>irrigation of root<br>canals | Various,<br>including<br>preparation,<br>cleaning and<br>irrigation of root<br>canals | Preparation,<br>cleaning and<br>irrigation of root<br>canals |
| Principle of<br>Operation | Generation of<br>hydroacoustic waves<br>and fluid motion.<br>The tip of the device<br>is placed inside the<br>tooth during<br>cleaning.<br>Hydroacoustics are<br>created by the water<br>stream flowing<br>through the guide<br>tube and coming<br>into contact with the<br>fluid inside the tooth<br>at the distal tip.<br>The fluid stream is<br>dispersed and<br>deflected by the<br>distal end plate of<br>the tube creating<br>hydrodynamics<br>(fluid motion)<br>within the tooth. | Generation of<br>hydroacoustic waves<br>and fluid motion.<br>The tip of the device<br>is placed inside the<br>tooth during<br>cleaning.<br>Hydroacoustics are<br>created by the water<br>stream flowing<br>through the guide<br>tube and coming<br>into contact with the<br>fluid inside the tooth<br>at the distal tip.<br>The fluid stream is<br>dispersed and<br>deflected by the<br>distal end plate of<br>the tube creating<br>hydrodynamics<br>(fluid motion)<br>within the tooth. | Generation of<br>hydroacoustic<br>waves and fluid<br>motion | Generation of<br>hydroacoustic<br>waves and fluid<br>motion |
| Treatment Site | Root canal | Root canal | Various,<br>including Root<br>canal | Root canal |
| Components | Control Unit<br>Irrigation reservoirs<br>Foot pedal<br>Handpiece<br>Accessories | Control Unit<br>Irrigation reservoirs<br>Foot pedal<br>Handpiece<br>Accessories | Control Unit<br>Irrigation<br>reservoirs<br>Foot pedal<br>Handpiece<br>Instruments | Handpiece<br>Instruments |
| Flow Rate | 45 +/- 10 ml/min. | 50-70 ml/min. | 0-50 ml/min. | Unspecified. |
| Duration of<br>Application | Leak test = 1<br>minute.<br>Treatment time = 7<br>minutes and 45<br>seconds. | Leak test = 1<br>minute.<br>Treatment time = 16<br>minutes. | Unspecified. | Unspecified. |
| Irrigation Fluid | NaOCl | NaOCL | NaOCL | Water |
| | EDTA | Water | Water | |
| | Water | | Chlorhexidine | |
| | | | Hydrogen | |
| | | | peroxide | |
| | | | Citric acid | |

Sonendo, Inc. Sonendo OmniClean Endotherapy System Page 2 of 3 Premarket Notification: K133752

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### Performance Data:

All necessary performance testing has been conducted for the Sonendo OmniClean Endotherapy System to assure substantial equivalence to the predicate devices and to demonstrate the devices perform as intended. All testing was performed on test units representative of finished devices. Testing included:

- Simulated Use ●
- EMC and Electrical Safety .
- Thermal Safety
- Hydroacoustics .
- Apical Extrusion and Pressure ●
- . Cleaning

### Basis for Determination of Substantial Equivalence:

Upon reviewing the safety and efficacy information provided in this submission and comparing intended use, principle of operation and overall technological characteristics, the Sonendo OmniClean Endotherapy System is determined by Sonendo, Inc., to be substantially equivalent to existing legally marketed devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three distinct strokes forming its body and wings. The symbol is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60

Silver Spring, MD 20993-0002

Public Health Service

#### May 15, 2014

Sonendo, Incorporated Mr. Dan Miller Vice President of Regulatory, Clinical Affairs, and Quality Assurance 26061 Merit Circle, Suite 101 Laguna Hills, CA 92653

Re: K133752

Trade/Device Name: Sonendo OmniClean Endotherapy System Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: April 15, 2014 Received: April 18, 2014

Dear Mr. Miller;

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. 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

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Page 2 - Mr. Miller

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.goy/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mary|S|Bunner -S

Erin I. Keith, M.S. 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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6. Indications for Use Statement

#### INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K133752

Device Name: Sonendo OmniClean Endotherapy System

Indications for Use:

The Sonendo OmniClean Endotherapy System is intended to prepare, clean and irrigate 181 and 2nd molar teeth indicated for root canal therapy.

AND/OR

Prescription Use _ X (Part 21 CFR 801 Subpart D)

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

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# Concurrence of CDRH, Office of Device Evaluation (ODE)

Sheena A. Green-S 2014.05.15 09:02:20 -04'00'

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