(154 days)
Not Found
No
The description focuses on Transcutaneous Electrical Nerve Stimulation (TENS) and does not mention any AI or ML components.
Yes
The device is intended to provide temporary dental anesthesia (pain relief) and alleviate oral pain, which are therapeutic functions. It also explicitly mentions its use for nerve stimulation and pain relief, aligning with the definition of a therapeutic device.
No
The device is intended to provide temporary dental anesthesia (pain relief) by numbing nerve pain through electrical stimulation (TENS). It is a treatment device, not one used to identify or diagnose a condition.
No
The device description explicitly states it is a "non-invasive electrical stimulation device" with "two metal electrodes" in place of bristles, indicating it is a hardware device that delivers electrical stimulation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices that are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The Dental Pain Eraser DPE-C300 is a device that applies electrical stimulation directly to the body (specifically, the gums and skin) to alleviate pain. It does not analyze any specimens taken from the body.
- Intended Use: The intended use is to provide temporary dental anesthesia and pain relief through direct application of electrical current, not through the analysis of biological samples.
Therefore, based on the provided information, the Dental Pain Eraser DPE-C300 falls under the category of a therapeutic device that provides pain relief through physical means, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
LWM
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral
Indicated Patient Age Range
pediatric (10 years through 22 years of age) and adult patients.
Intended User / Care Setting
dental/orthodontic professionals
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)
Nonclinical Testing Summary:
The nonclinical, bench testing included:
- Visual Inspection
- Functional Testing
- Tip Assembly Pull Testing
- Product Lifetime Testing
- Water Ingress Testing
- Marking Durability
- Transportation Testing
- Biocompatibility
- Electrical Safety and Electromagnetic Compatibility Testing
Biocompatibility testing was performed on the Dental Pain Eraser, and results demonstrated that it passed tests for Cytotoxicity, Sensitization (0.9% Sodium Chloride Injection Extract and Skin Sesame oil Extract), and Irritation (0.9% Sodium Chloride Injection Extract and Sesame Oil Extract).
The collective results of the nonclinical testing demonstrate that the materials chosen, the manufacturing processes, and design of the Dental Pain Eraser meet the established specifications necessary for consistent performance during its intended use.
Clinical Testing Summary:
Three clinical studies were performed:
-
CSP-TENS-002: The effect of the Dental Pain Eraser intraoral portable TENS device on periodontal, mucosal and dentinal pain related to adolescent and adult orthodontic treatment.
- Description: Patients experiencing immediate orthodontic pain following orthodontic adjustment during the leveling and aligning phase of orthodontic treatment with moderate to severe crowding were selected. Baseline demographic information collected included age and sex.
- Key Results: This study demonstrated that a portable TENS delivery through the Dental Pain Eraser device performs as intended at relieving periodontal, mucosal and dentinal pain related to orthodontic treatment of adolescents and adults. No adverse device effects were reported.
-
CSP-TENS-003: The effect of the Dental Pain Eraser intraoral portable TENS device on periodontal pain relief due to orthodontic separator placement: A randomized controlled trial.
- Description: Patients were randomly assigned to one of three treatment groups after elastic separators were placed: Group 1 (Experimental Group) used the Dental Pain Eraser activated for ~10 seconds; Group 2 (Sham Group) used the device placed but not turned on; Group 3 (Control Group) did not use the device. All groups completed pain assessment questionnaires. Baseline demographic information collected included age and sex.
- Key Results: The study confirmed that the Dental Pain Eraser relieves periodontal pain following separator placement during the first 3 days cumulatively when the greatest pain is normally experienced. No adverse device effects were reported.
-
CSP-TENS-001: Preliminary Pilot Study Done by Doctor Cosmo Haralambidis at Cranston Orthodontics.
- Description: Patients with periodontal pain associated with orthodontic appliance adjustment were studied. Baseline demographic information collected included age and sex.
- Key Results: The study suggests that the Dental Pain Eraser alleviates post orthodontic appliance adjustment tooth pain. No adverse device effects were reported in this study.
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.
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
Not Found
N/A
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right is written in blue and white. The text is arranged in three lines, with "FDA" on the first line, "U.S. FOOD & DRUG" on the second line, and "ADMINISTRATION" on the third line.
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.
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
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) | ☑ |
|---|---|
| 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: 401-932-9877 Fax: 401-464-8903
Contact Person:
Valerie Defiesta-Ng VP, Regulatory Affairs Experien Group, LLC 224 Airport Parkway, Suite 250 San Jose, CA, 95110 USA Phone: 408-400-0856 FAX: 408-400-0865
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
(Proposed Device) | CEDETA Mk2
(Predicate Device) | Rationale for Substantial Equivalence |
|-------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K182947 | K915717 | -- |
| Indications for Use (IFU) | 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 CEDETA Mk2 delivers effective
pain control for a wide range of
treatments.
Note: Indications for use is not
specifically stated, but the statement
above is stated in the CEDETA Mk2
Operators Manual. | Both devices have the same intended use
as both are used in the treatment of pain
resulting from dental and orthodontic
procedures. The proposed device treats
pain related to dental and orthodontic
procedures, as well as other sources as oral
pain, while the predicate treats pain related
to a variety of dental treatments. This
difference does not raise different
questions related to safety and
effectiveness. |
| 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. | -- | Synapse is proposing the inclusion of the
pediatric patient subpopulation which does
not raise different questions of safety or
effectiveness than the predicate as
demonstrated by the bench and clinical
testing, which specifically include a
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
Batteries | Four AA Alkaline Batteries | The differences in power source do not
raise different questions of safety or
effectiveness than the predicate device as
demonstrated by performance testing. |
| ● Method of Line Current
Isolation | Not connected to the line | Not connected to the line | N/A (same) |
| Characteristic | Dental Pain Eraser
(Proposed Device) | CEDETA Mk2
(Predicate Device) | Rationale for Substantial
Equivalence |
| • Patient Leakage Current | | | |
| o Normal Condition
(μA) | DC ~ 0μA AC