K Number

Device Name

Dental Pain Eraser

Manufacturer

Synapse Dental

Date Cleared

2020-01-17

(25 days)

Product Code

LWM

Regulation Number

N/A

Intended Use

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.

Device Description

The Dental Pain Eraser DPE-C300 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 DPE-C300 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 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. The Dental Pain Eraser is intended for the alleviation of oral pain for pediatric (10 years through 22 years of age) and adult patients. The modified Dental Pain Eraser DPE-C300 is a multi-use device to be used in a dental/orthodontic facility.

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

K182947

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on electrical stimulation (TENS) and cleaning/disinfection validation, with no mention of AI or ML technologies.

Therapeutic

Yes
The device is intended to provide temporary dental anesthesia (pain relief) and alleviate oral pain before, during, or after dental and orthodontic procedures, which is a therapeutic purpose.

Diagnostic

Explanation: The device is intended to provide temporary pain relief (anesthesia) through electrical stimulation, not to diagnose a condition.

SaMD (Software as a Medical Device)

The device description explicitly states it is an "electrical stimulation device" with "two metal electrodes" and a "shape and size similar to a common toothbrush," indicating it is a physical hardware device that delivers electrical current. The performance studies also focus on cleaning, disinfecting, and mechanical testing of the hardware components.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
Device Function: The Dental Pain Eraser DPE-C300 is a device that applies electrical stimulation directly to the body (gums and skin) to alleviate pain. It does not analyze any biological samples.
Intended Use: The intended use is to provide temporary dental anesthesia and pain relief through direct application, not through the analysis of in vitro samples.

Therefore, based on the provided information, the Dental Pain Eraser DPE-C300 is a therapeutic device, not an in vitro diagnostic device.

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)

LWM

Device Description

The Dental Pain Eraser DPE-C300 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 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. The Dental Pain Eraser is intended for the alleviation of oral pain for pediatric (10 years through 22 years of age) and adult patients. The modified Dental Pain Eraser DPE-C300 is a multi-use device to be used in a dental/orthodontic facility.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Oral (gums, intact skin around canker sores)

Indicated Patient Age Range

pediatric (10 years through 22 years of age) and adult patients.

Intended User / Care Setting

dental/orthodontic professionals; Professional Dental/Orthodontic Facility

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)

Synapse performed a cleaning and disinfecting validation in accordance with the following standards:

Guidance for Industry and Food and Drug Administration Staff, Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, Document Issued on March 17, 2015, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Office of Device Evaluations.
AAMI TIR12:2010, Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers.
AAMI TIR12-30:2011/(R)2016. A compendium of processes. materials, test methods, and acceptance criteria for cleaning reusable medical devices, December 15, 2016.
Guidance for Industry and FDA Reviewers, Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants/High Level Disinfectants." FDA CDRH, January 3, 2000.
ASTM E1837-96 (2014), Standard Test Method to Determine Efficacy of Disinfection Processes for Reusable Medical Devices (Simulated Use Test).

The results of the collective testing demonstrate that differences between the modified Dental Pain Eraser DPE-C300 as a multi-use device and the predicate as a single-use device do not raise different questions of safety or effectiveness and that the modified Dental Pain Eraser DPE-C300 is substantially equivalent to the predicate Dental Pain Eraser DPE-C300 (K182947).

Nonclinical Testing Summary:
The nonclinical, bench testing included:

Cleaning Validation
Disinfecting Validation/Residual Cytotoxicity Testing
Cycle Testing
Tip Assembly Pull Testing

The collective results of the nonclinical testing demonstrate that the cleaning and disinfection processes, in conjunction with the cycle and pull testing performed meet the established specifications necessary for consistent performance during its intended use. In addition, the collective bench testing demonstrates that the Dental Pain Eraser DPE-C300 does not raise new questions of safety or effectiveness when used as a multi-use device when compared to the predicate device.

Clinical Testing Summary:
Clinical testing was not required to establish substantial equivalence

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.

K182947

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

N/A

Summary

Image /page/0/Picture/0 description: The image contains 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.

January 17, 2020

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

Re: K193570

Trade/Device Name: Dental Pain Eraser Regulatory Class: Unclassified Product Code: LWM Dated: December 20, 2019 Received: December 23, 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.

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 medical devices and radiation-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,

for Srinivas 'Nandu'' Nandkumar, Ph.D. 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

510(k) Notification K193570

GENERAL INFORMATION [807.92(a)(1)]

Applicant:

Synapse Dental 67 Phenix Avenue Cranston, RI 02920 USA Phone: 401-932-9877 Fax: 401-464-8903

Contact Person:

Valerie Defiesta-Ng Vice President, Regulatory Affairs Experien Group, LLC 224 Airport Parkway, Suite 250 San Jose, CA 95110 USA

Date Prepared: December 20, 2019

DEVICE INFORMATION [807.92(a)(2)]

Classification: Unclassified, Pre-Amendment

Product Code: LWM

Trade Name: Dental Pain Eraser DPE-C300

Generic/Common Name: Device, Electrical Dental Anesthesia

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

Dental Pain Eraser DPE-C300 (K182947)

DEVICE DESCRIPTION [807.92(a)(4)]

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. The Dental Pain Eraser is intended for the alleviation of oral pain for pediatric (10 years through 22 years of age) and adult patients. The modified Dental Pain Eraser DPE-C300 is a multi-use device to be used in a dental/orthodontic facility.

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

SUBSTANTIAL EQUIVALENCE

The modified Dental Pain Eraser DPE-C300 is substantially equivalent to the predicate device with regard to function and physical characteristics. The difference as a multi-use device versus a single-use device does not raise any different issues of safety or effectiveness. Thus, the modified Dental Pain Eraser DPE-C300 is substantially equivalent to the predicate device.

PERFORMANCE DATA [807.92(b)]

Synapse performed a cleaning and disinfecting validation in accordance with the following standards:

o Guidance for Industry and Food and Drug Administration Staff, Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, Document Issued on March 17, 2015, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Office of Device Evaluations.
0 AAMI TIR12:2010, Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers.
o AAMI TIR12-30:2011/(R)2016. A compendium of processes. materials, test methods, and acceptance criteria for cleaning reusable medical devices, December 15, 2016.
Guidance for Industry and FDA Reviewers, Content and Format of Premarket o Notification [510(k)] Submissions for Liquid Chemical Sterilants/High Level Disinfectants." FDA CDRH, January 3, 2000.
ASTM E1837-96 (2014), Standard Test Method to Determine Efficacy of Disinfection 0 Processes for Reusable Medical Devices (Simulated Use Test).

Nonclinical Testing Summary [807.92(b)(1)]:

The nonclinical, bench testing included:

Cleaning Validation ●
o Disinfecting Validation/Residual Cytotoxicity Testing
o Cycle Testing
Tip Assembly Pull Testing ●

Clinical Testing Summary [807.92(b)(2)]:

Clinical testing was not required to establish substantial equivalence

CONCLUSIONS [807.92(b)(3)]

Extensive nonclinical testing has been performed on the Dental Pain Eraser to evaluate the overall performance of the device. The collective results confirm that the Dental Pain Eraser meets its specifications and meets the requirements of a multi-use device. The Dental Pain Eraser is substantially equivalent to the predicate device.

K193570
Table 1: Substantial Equivalence Table
Characteristic	Dental Pain Eraser
DPE-C300
(Proposed Device)	Dental Pain Eraser
DPE-C300
(Predicate Device)	Rationale for Substantial Equivalence
510(k) Number	TBD	K182947
Indications for Use	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.	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.	N/A (same)
Intended User or Patient
Population	The Dental Pain Eraser is intended for use by
dental/orthodontic professionals for the
alleviation of oral pain in their pediatric (10
years through 22 years of age) and adult
patients.	The Dental Pain Eraser is intended for use by
dental/orthodontic professionals for the
alleviation of oral pain in their pediatric (10
years through 22 years of age) and adult
patients.	N/A (same)
Use Environment	Professional Dental/Orthodontic Facility	Professional Dental/Orthodontic Facility	N/A (same)
Single-use or Multi-use	Multi-use	Single-use	The change in use does not raise different
questions of safety and effectiveness as
demonstrated by the cleaning, disinfection
and performance testing.
Product Code	LWM	LWM	N/A (same)
Classification	Unclassified, Pre-amendment	Unclassified, Pre-amendment	N/A (same)
Manufacturer	Synapse Dental	Synapse Dental	N/A (same)
Power Source(s)	Three (3) 393/309 Silver Oxide Button Cell
Batteries	Three (3) 393/309 Silver Oxide Button Cell
Batteries	N/A (same)
Method of Line Current
Isolation	Not connected to the line	Not connected to the line	N/A (same)

		Rationale for Substantial Equivalence
	Dental Pain Eraser
DPE-C300
(Predicate Device)	DC ~ 0μA AC