Dental Pain Eraser

K182947 · Synapse Dental, LLC · LWM · Mar 26, 2019 · DE

Device Facts

• Record ID: K182947
• Device Name: Dental Pain Eraser
• Applicant: Synapse Dental, LLC
• Product Code: LWM · DE
• Decision Date: Mar 26, 2019
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic, Pediatric

Indications for Use

The Dental Pain Eraser is intended for use by dental/orthodontic professionals for the alleviation of oral pain in pediatric (10 years through 22 years of age) and adult patients.

Device Story

Dental Pain Eraser is a non-invasive, pen-shaped, battery-powered TENS device; used by dental/orthodontic professionals to alleviate oral pain. Device features two metal electrodes in place of toothbrush bristles; operator rubs electrodes on gums near aching tooth or around canker sores for 30 seconds to 10 minutes. Device delivers electrical stimulation to anesthetize nerves; provides temporary pain relief for orthodontic procedures and oral pain. Output is firmware-controlled; includes automatic shut-off after 5 minutes. Clinical benefits include reduction of periodontal, mucosal, and dentinal pain; no adverse effects reported in clinical studies.

Clinical Evidence

Three clinical studies (CSP-TENS-001, 002, 003) evaluated efficacy in pediatric and adult patients. CSP-TENS-003 was a randomized controlled trial comparing the device to sham and control groups for pain following orthodontic separator placement; results confirmed cumulative pain relief over the first 3 days. CSP-TENS-002 and 001 demonstrated efficacy in relieving periodontal, mucosal, and dentinal pain related to orthodontic adjustments. No adverse device effects were reported across all studies.

Technological Characteristics

Pen-shaped TENS device; dimensions ~6.27" length, ~0.5-1.04" diameter. Materials: ABS (Lustran 348), Grey (Clariant SB7M665060), 303 Stainless Steel. Power: 3x 393/309 silver oxide button cells. Output: 2-channel, alternating, voltage-regulated, biphasic, charge-neutral waveform. Connectivity: Standalone. IP21 ingress protection. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 62304, ANSI/AAMI NS4:2013, ISO 7405, ISO 10993-1, IEC 62366-1, ISO 14971.

Indications for Use

Indicated for temporary dental anesthesia (pain relief) before, during, or after dental and orthodontic procedures, and other sources of oral pain. Intended for use by dental/orthodontic professionals in pediatric (10-22 years) and adult patients.

Predicate Devices

• CEDETA Mk2 (K915717)

Submission Summary (Full Text)

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March 26,2019

Synapse Dental, LLC % Valerie Defiesta-Ng Vice President, Regulatory Affairs Experien Group, LLC 224 Airport Parkway, Suite 250 San Jose, California 95110

Re: K182947

Trade/Device Name: Dental Pain Eraser Regulatory Class: Unclassified Product Code: LWM Dated: February 21, 2019 Received: February 22, 2019

Dear Valerie Defiesta-Ng:

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.

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 medical devices and radiation-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,

Digitally signed by Mary S. Mary S. Runner -S3 Runner -S3 Date: 2019.03.26

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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# Indications for Use

510(k) Number (if known)

K182947

Device Name Dental Pain Eraser DPE-C300

#### Indications for Use (Describe)

The Dental Pain Eraser DPE-C300 is intended to provide temporary dental anesthesia (pain relief) and is indicated for use before, during, or after dental and orthodontic procedures, and other sources of oral pain. It is intended for use by dentall orthodontic professionals for the alleviation of oral pain.

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

| Description Use (Ref 24 CFR 983.3 Subpart D) | <span style="font-size: 20px;"><b>☑</b></span> |
|----------------------------------------------|------------------------------------------------|
| Over-The-Counter Use (21 CFR 201 Subpart D) | ☐ |

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(k) Notification K182947

# GENERAL INFORMATION [807.92(a)(1)]

# Applicant:

Synapse Dental, LLC 59 Phenix Avenue Cranston, RI 02920 USA Phone: [phone] Fax: [phone]

# Contact Person:

Valerie Defiesta-Ng VP, Regulatory Affairs Experien Group, LLC 224 Airport Parkway, Suite 250 San Jose, CA, 95110 USA Phone: [phone] FAX: [phone]

## Date Prepared: February 21, 2018

### DEVICE INFORMATION [807.92(a)(2)]

# Trade Name:

Dental Pain Eraser

### Generic/Common Name:

Device, Electrical Dental Anesthesia

### Classification:

Unclassified, Pre-Amendment

### Product Code:

LWM

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# PREDICATE DEVICE(S) [807.92(a)(3)]

The Dental Pain Eraser is substantially equivalent to the cleared CEDETA Mk2 device (K915717). The devices have the same intended uses, as both are used by dental professionals in the treatment of pain resulting from dental and orthodontic procedures. The technological differences between the Dental Pain Eraser and the CEDETA Mk2 do not raise any different questions of safety and effectiveness.

## DEVICE DESCRIPTION [807.92(a)(4)]

The Dental Pain Eraser is a non-invasive electrical stimulation device that is used to numb the nerve pain associated with orthodontic procedures and to dull the pain of canker sores often developed inside the mouths of patients wearing braces or retainers. This method of treatment is referred to as Transcutaneous Electrical Nerve Stimulation (TENS).

The Dental Pain Eraser has a shape and size similar to a common toothbrush, except that in place of the bristles are two metal electrodes. In operation, the device is turned on and for 30 seconds to 10 minutes the two electrodes are rubbed gently up and down the gums above the patient's aching tooth or on the intact skin around the canker sore. Current flowing between the electrodes through the gum anesthetizes the nearby nerves thus alleviating pain.

## INDICATIONS FOR USE [807.92(a)(5)]

The Dental Pain Eraser DPE-C300 is intended to provide temporary dental anesthesia (pain relief) and is indicated for use before, during, or after dental and orthodontic procedures, and other sources of oral pain. It is intended for use by dental/orthodontic professionals for the alleviation of oral pain.

# INTENDED USE [807.92(a)(5)]

The Dental Pain Eraser is intended for use by dental/orthodontic professionals for the alleviation of oral pain in pediatric (10 years through 22 years of age) and adult patients.

## COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE [807.92(a)(6)]

The Dental Pain Eraser is similar to the predicate device with respect to the intended use, safety characteristics and technological characteristics. To demonstrate that any differences between the Dental Pain Eraser and the predicate device do not raise different questions of safety and effectiveness, Synapse performed comprehensive design verification testing and clinical testing. Verification testing included biocompatibility testing, IEC and EMC testing, water ingress testing and performance testing to demonstrate that the device met all required specifications and performs as intended. Synapse conducted clinical studies to demonstrate the Dental Pain Eraser can be used for pain relief as safely and effectively as its predicate. In addition, where required, testing was performed in accordance with the current standards as listed in Section 21: "Performance Standards."

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### SUBSTANTIAL EQUIVALENCE

The Dental Pain Eraser and the predicate device, CEDETA Mk2 (K915717), are substantially equivalent with regard to intended use, product labeling, anatomical sites, patient population, performance testing, technological characteristics and safety characteristics.

Synapse has completed comprehensive design verification testing (including software verification testing), electrical safety and electromagnetic compatibility testing, biocompatibility testing, transportation testing and clinical testing. The Dental Pain Eraser passed all tests. The minor differences in the technological characteristics. indications for use and product labeling between the proposed device and the predicate device have been evaluated and determined to not raise any different questions of safety and effectiveness. As such, the Dental Pain Eraser is substantially equivalent to the cleared CEDETA Mk2 device. A comparison table summarizing the specifications and features of the Dental Pain Eraser and the predicate device is included in Table 1.

In regard to the other technological characteristics, Table 2 summarizes the output parameters of the Dental Pain Eraser and the predicate device.

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| Characteristic | Dental Pain Eraser<br>(Proposed Device) | CEDETA Mk2<br>(Predicate Device) | Rationale for Substantial Equivalence |
|-------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K182947 | K915717 | -- |
| Indications for Use (IFU) | The Dental Pain Eraser DPE-C300 is<br>intended to provide temporary dental<br>anesthesia (pain relief) and is indicated<br>for use before, during, or after dental and<br>orthodontic procedures, and other<br>sources of oral pain. It is intended for<br>use by dental/orthodontic professionals<br>for the alleviation of oral pain. | The CEDETA Mk2 delivers effective<br>pain control for a wide range of<br>treatments.<br>Note: Indications for use is not<br>specifically stated, but the statement<br>above is stated in the CEDETA Mk2<br>Operators Manual. | Both devices have the same intended use<br>as both are used in the treatment of pain<br>resulting from dental and orthodontic<br>procedures. The proposed device treats<br>pain related to dental and orthodontic<br>procedures, as well as other sources as oral<br>pain, while the predicate treats pain related<br>to a variety of dental treatments. This<br>difference does not raise different<br>questions related to safety and<br>effectiveness. |
| Intended User or Patient<br>Population | The Dental Pain Eraser is intended for<br>use by dental/ orthodontic professionals<br>for the alleviation of oral pain in their<br>pediatric (10 years through 22 years of<br>age) and adult patients. | -- | Synapse is proposing the inclusion of the<br>pediatric patient subpopulation which does<br>not raise different questions of safety or<br>effectiveness than the predicate as<br>demonstrated by the bench and clinical<br>testing, which specifically include a<br>pediatric population. |
| Product Code | LWM | LWM | N/A (same) |
| Classification | Unclassified, Pre-amendment | Unclassified, Pre-amendment | N/A (same) |
| Manufacturer | Synapse Dental, Inc. | CEDETA Dental International, Inc. | -- |
| Power Source(s) | Three 393/309 Silver Oxide Button Cell<br>Batteries | Four AA Alkaline Batteries | The differences in power source do not<br>raise different questions of safety or<br>effectiveness than the predicate device as<br>demonstrated by performance testing. |
| ● Method of Line Current<br>Isolation | Not connected to the line | Not connected to the line | N/A (same) |
| Characteristic | Dental Pain Eraser<br>(Proposed Device) | CEDETA Mk2<br>(Predicate Device) | Rationale for Substantial<br>Equivalence |
| • Patient Leakage Current | | | |
| o Normal Condition<br>(μA) | DC ~ 0μA AC<10mA | Unknown | The differences in leakage current do not<br>raise different questions of safety or |
| o Single Fault Condition<br>(μA) | DC~0μA AC<10mA | Unknown | effectiveness than the predicate device as<br>demonstrated by performance testing. |
| Average DC current through<br>electrodes when device is on<br>but no pulses are being applied<br>(μΑ) | 0μA | Unknown | The differences in technological<br>characteristics between the two devices do<br>not raise different questions of safety or<br>effectiveness than the predicate device as |
| Number of Output modes | 1<br>(As requested per Q180245, see Table 2<br>for the Output Specifications) | Continuously adjustable power by the<br>patient | demonstrated by performance testing. |
| Number of Output Channels | 2 | 1 or 2 | |
| • Synchronous or<br>Alternating? | Alternating | Synchronous | |
| • Method of Channel<br>Isolation | Not isolated | Not isolated | |
| Regulated Current or<br>Regulated Voltage? | Voltage | Power | |
| Software/Firmware/<br>Microprocessor Control? | Firmware | Firmware | |
| Automatic Overload Trip? | No | Unknown | |
| Automatic No-Load Trip? | No | Unknown | |
| Automatic Shut Off? | Yes | Unknown | |
| User Override Control? | Yes | Yes | |
| Characteristic | Dental Pain Eraser<br>(Proposed Device) | CEDETA Mk2<br>(Predicate Device) | Rationale for Substantial Equivalence |
| Indicator Display | | | |
| • On/Off Status? | Yes | Yes | N/A (same) |
| • Low Battery? | No | Unknown | The differences in display between the two<br>devices do not raise different questions of |
| • Voltage/Current Level? | No | Yes | safety or effectiveness than the predicate<br>device as demonstrated by performance<br>testing. |
| Timer Range (minutes) | 5 min Max | Dentist controlled | The feature of a timer range does not raise<br>different questions of safety or effectiveness<br>as demonstrated by performance testing. |
| Compliance with Voluntary<br>Standards | Compliant with applicable requirements<br>of:<br>IEC 60601-1, IEC 60601-1-2, IEC<br>60601-2-10, IEC 62304<br>ANSI/AAMI NS4:2013 –<br>Transcutaneous Electrical Nerve<br>Stimulators<br>ISO 7405: Second edition 2008-12-15<br>Dentistry - Evaluation of<br>biocompatibility of medical devices used<br>in dentistry [Including: Amendment 1<br>(2013)].<br>ISO 10993-1:2009 Biological evaluation<br>of medical devices – Part 1: Evaluation<br>and testing within a risk management<br>process | British Standard 5724 - Medical<br>electrical equipment. Specification for<br>general safety requirements | Synapse has verified the Dental Pain Eraser<br>is compliant to the most current applicable<br>standards. |
| Characteristic | Dental Pain Eraser<br>(Proposed Device) | CEDETA Mk2<br>(Predicate Device) | Rationale for Substantial Equivalence |
| Compliance with Voluntary<br>Standards (continued) | IEC 62366-1:2015, Medical devices.<br>Part 1: Application of usability engineering to medical devices<br><br>ISO 14971:2012, Medical Devices.<br>Application of Risk Management to Medical Devices | | |
| Compliance with 21 CFR 898? | Not applicable | Unknown | -- |
| Weight (oz.) | 0.423oz | Unknown | Physical differences do not raise different questions of safety or effectiveness |
| Unit Body Dimensions (in.)<br>Two Electrode Probes:<br>Dimensions (in.) | Pen-shaped ~0.5" to ~1.04" Dia.,<br>Length ~6.27"<br>0.118in Dia., 0.157in, Center to center spacing | Fits in the palm of patient's hand | |
| Patient Contacting<br>Materials | Tip Assembly with Electrodes:<br>• Lustran 348 WT012002 (ABS)<br>• Clariant SB7M665060, GREY<br>• 303 Stainless Steel | Unknown | Differences in mucous-contacting materials do not raise different questions of safety or effectiveness as demonstrated by biocompatibility testing. |
| Biocompatible | Biocompatibility testing was performed per ISO 10993-1 and FDA Guidance Document, Use of 10993-1, “Biological Evaluation of medical devices – Part 1: Evaluation and testing within a risk management process,” issued June 16, 2016 | Unknown | |
| Ingress Protection Rating | IP21 | Unknown | Synapse has tested the Dental Pain Eraser to IEC 60529 per IP21. No different questions of safety or effectiveness are raised |
| | Description | Dental Pain Eraser<br>(Proposed Device) | CEDETA Mk2<br>(Predicate Device) |
| | Mode or Program Name | Only one Mode | Multi-mode |
| | Indication for Use | Pulsing Light | Tingling sensation |
| | Waveform (e.g., pulsed monophasic, biphasic) | Complex, Biphasic, Charge Neutral<br>(See Detailed Description) | Continuous Pure Biphasic Sinusoidal with<br>zero DC offset |
| | Shape (e.g., rectangular, spike, rectified sinusoidal) | Rectangular | Sinusoidal |
| | Pole Configuration (e.g., 2-pole, 4-pole) – For<br>interferential current only | NA | Not Known |
| | Maximum Output Voltage (V) (+/- 10%) | 2.08@ 500Ω | -- |
| | | 2.74@ 1kΩ | 25@ 1kΩ |
| | | 4.24@ 10kΩ | -- |
| | Maximum Output Current (mA) (+/-10%) | 4.16@ 500Ω | -- |
| | | 2.74@ 1kΩ | 25@ 1kΩ |
| | | 0.42@ 10kΩ | -- |
| | Duration of primary (depolarizing) phase† (msec) | | |
| | High Frequency Pulse duration (μs) | 50μs on, 50μs off | sinusoid 7.7ms period |
| | High Frequency (Hz) [or Rate (pps)] | 10kHz…