(154 days)
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 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.
This document describes the regulatory submission for the "Dental Pain Eraser DPE-C300" (K182947), which is a non-invasive electrical stimulation device intended to provide temporary dental pain relief. The submission aims to demonstrate substantial equivalence to a predicate device, the "CEDETA Mk2" (K915717).
Based on the provided document, here's a breakdown of the acceptance criteria and the supporting study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of pre-defined acceptance criteria with specific numerical targets. Instead, it demonstrates substantial equivalence by comparing the proposed device to a predicate device across various characteristics and stating that comprehensive testing confirmed its performance and safety are comparable. The "Acceptance Criteria" here are implicitly meeting the specifications and safety/effectiveness profile comparable to the predicate device.
However, we can infer some "performance" points from the clinical study summaries.
| Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Pain Relief (General Dental/Orthodontic Pain) | Device performs as intended in relieving periodontal, mucosal, and dentinal pain related to orthodontic treatment. | CSP-TENS-002: Demonstrated that the device performs as intended at relieving periodontal, mucosal, and dentinal pain related to orthodontic treatment of adolescents and adults. |
| Pain Relief (Orthodontic Separator Pain) | Device effectively alleviates tooth pain after orthodontic separator placement, especially during the period of greatest pain. | CSP-TENS-003: Confirmed that the device relieves periodontal pain following separator placement during the first 3 days cumulatively when the greatest pain is normally experienced. |
| Pain Relief (Post-Orthodontic Adjustment Pain) | Device alleviates post-orthodontic appliance adjustment tooth pain. | CSP-TENS-001: Suggested that the device alleviates post-orthodontic appliance adjustment tooth pain. |
| Safety | No adverse device effects reported. | All three clinical studies (CSP-TENS-002, CSP-TENS-003, CSP-TENS-001): "No adverse device effects were reported." |
| Biocompatibility | Materials are biocompatible and meet relevant ISO standards. | Table 3: All tests for Cytotoxicity, Sensitization (Sodium Chloride & Sesame oil Extract), and Irritation (Sodium Chloride & Sesame oil Extract) Passed per ISO 10993-5 and ISO 10993-10 standards. |
| Electrica Safety & EMC | Compliant with applicable standards. | Nonclinical Testing Summary: "Electrical Safety and Electromagnetic Compatibility Testing" was performed and passed. Compliant with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10. |
| Water Ingress | Device meets specified ingress protection rating. | Nonclinical Testing Summary: "Water Ingress Testing" was performed and passed. Ingress Protection Rating IP21. |
| Overall Performance | Meets established specifications and exhibits required mechanical and functional characteristics. | Conclusions: "The collective results confirm that the Dental Pain Eraser meets its specifications and exhibits the required mechanical and functional characteristics for its intended use..." |
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not explicitly state the exact sample sizes for the clinical studies (CSP-TENS-001, CSP-TENS-002, CSP-TENS-003). It mentions "patients" in general terms.
- CSP-TENS-002: Patients selected during the leveling and aligning phase of orthodontic treatment with moderate to severe crowding experiencing immediate orthodontic pain.
- CSP-TENS-003: Patients randomly assigned to one of three treatment groups (Experimental, Sham, Control).
- CSP-TENS-001: Patients with periodontal pain associated with orthodontic appliance adjustment.
Data Provenance:
- The clinical studies were conducted by Synapse Dental, LLC.
- CSP-TENS-001 was a preliminary pilot study done by Doctor Cosmo Haralambidis at Cranston Orthodontics, Cranston, RI, United States.
- The document does not specify whether the studies were retrospective or prospective, but clinical trials are typically prospective. The mention of patient selection, randomization (for CSP-TENS-003), and pain assessment questionnaires strongly suggests prospective studies.
- The country of origin for the clinical data appears to be USA (Cranston, RI mentioned for CSP-TENS-001).
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not discuss "ground truth" in the context of expert review for the clinical studies, as the device is for pain relief, which is a subjective patient experience. The "ground truth" for efficacy would be the reported pain levels by the patients themselves. Pain assessment questionnaires were used for CSP-TENS-003.
For the non-clinical testing, the "ground truth" is established by the specifications and standards (e.g., IEC, ISO, ANSI/AAMI) the device was tested against. The expertise lies in the certified laboratories and engineers performing these tests.
4. Adjudication Method for the Test Set
Not applicable in the context of this device and the clinical studies described. Pain relief is self-reported, not externally adjudicated by multiple experts viewing objective data.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study is typically performed for diagnostic imaging devices where human readers interpret images. This is not applicable to the "Dental Pain Eraser," which is a therapeutic electrical stimulation device for pain relief. The studies conducted compare the device's effect to a control/sham, not the improvement of human readers' performance with AI assistance.
6. Standalone Performance
The clinical studies describe the performance of the device itself (with a human operator, the dental/orthodontic professional, applying it), not an algorithm in isolation. The "performance" in this context is the alleviation of pain in patients when the device is used as intended. The studies assess the direct effect of the device on patient pain levels.
7. Type of Ground Truth Used
The primary "ground truth" for efficacy in the clinical studies is patient-reported pain levels validated via pain assessment questionnaires (explicitly mentioned for CSP-TENS-003). Safety "ground truth" is based on the absence of reported adverse device effects. For non-clinical tests, the ground truth is adherence to engineering specifications and international standards.
8. Sample Size for the Training Set
This product is a medical device for therapeutic use (pain relief), not an AI/ML model that requires a "training set" in the machine learning sense. Therefore, the concept of a training set sample size is not applicable here. The device's design is based on established principles of Transcutaneous Electrical Nerve Stimulation (TENS) and engineering.
9. How the Ground Truth for the Training Set Was Established
As this is not an AI/ML device, there isn't a "training set" or "ground truth" for it in that context. The device's design and operating parameters (e.g., output voltage, current, waveform) are based on the intended physiological effects of TENS and are validated through the non-clinical and clinical performance data.
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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 (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 isintended to provide temporary dentalanesthesia (pain relief) and is indicatedfor use before, during, or after dental andorthodontic procedures, and othersources of oral pain. It is intended foruse by dental/orthodontic professionalsfor the alleviation of oral pain. | The CEDETA Mk2 delivers effectivepain control for a wide range oftreatments.Note: Indications for use is notspecifically stated, but the statementabove is stated in the CEDETA Mk2Operators Manual. | Both devices have the same intended useas both are used in the treatment of painresulting from dental and orthodonticprocedures. The proposed device treatspain related to dental and orthodonticprocedures, as well as other sources as oralpain, while the predicate treats pain relatedto a variety of dental treatments. Thisdifference does not raise differentquestions related to safety andeffectiveness. |
| Intended User or PatientPopulation | The Dental Pain Eraser is intended foruse by dental/ orthodontic professionalsfor the alleviation of oral pain in theirpediatric (10 years through 22 years ofage) and adult patients. | -- | Synapse is proposing the inclusion of thepediatric patient subpopulation which doesnot raise different questions of safety oreffectiveness than the predicate asdemonstrated by the bench and clinicaltesting, which specifically include apediatric 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 CellBatteries | Four AA Alkaline Batteries | The differences in power source do notraise different questions of safety oreffectiveness than the predicate device asdemonstrated by performance testing. |
| ● Method of Line CurrentIsolation | 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 SubstantialEquivalence |
| • Patient Leakage Current | |||
| o Normal Condition(μA) | DC ~ 0μA AC<10mA | Unknown | The differences in leakage current do notraise different questions of safety or |
| o Single Fault Condition(μA) | DC~0μA AC<10mA | Unknown | effectiveness than the predicate device asdemonstrated by performance testing. |
| Average DC current throughelectrodes when device is onbut no pulses are being applied(μΑ) | 0μA | Unknown | The differences in technologicalcharacteristics between the two devices donot raise different questions of safety oreffectiveness than the predicate device as |
| Number of Output modes | 1(As requested per Q180245, see Table 2for the Output Specifications) | Continuously adjustable power by thepatient | demonstrated by performance testing. |
| Number of Output Channels | 2 | 1 or 2 | |
| • Synchronous orAlternating? | Alternating | Synchronous | |
| • Method of ChannelIsolation | Not isolated | Not isolated | |
| Regulated Current orRegulated Voltage? | Voltage | Power | |
| Software/Firmware/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(Proposed Device) | CEDETA Mk2(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 twodevices do not raise different questions of |
| • Voltage/Current Level? | No | Yes | safety or effectiveness than the predicatedevice as demonstrated by performancetesting. |
| Timer Range (minutes) | 5 min Max | Dentist controlled | The feature of a timer range does not raisedifferent questions of safety or effectivenessas demonstrated by performance testing. |
| Compliance with VoluntaryStandards | Compliant with applicable requirementsof:IEC 60601-1, IEC 60601-1-2, IEC60601-2-10, IEC 62304ANSI/AAMI NS4:2013 –Transcutaneous Electrical NerveStimulatorsISO 7405: Second edition 2008-12-15Dentistry - Evaluation ofbiocompatibility of medical devices usedin dentistry [Including: Amendment 1(2013)].ISO 10993-1:2009 Biological evaluationof medical devices – Part 1: Evaluationand testing within a risk managementprocess | British Standard 5724 - Medicalelectrical equipment. Specification forgeneral safety requirements | Synapse has verified the Dental Pain Eraseris compliant to the most current applicablestandards. |
| Characteristic | Dental Pain Eraser(Proposed Device) | CEDETA Mk2(Predicate Device) | Rationale for Substantial Equivalence |
| Compliance with VoluntaryStandards (continued) | IEC 62366-1:2015, Medical devices.Part 1: Application of usability engineering to medical devicesISO 14971:2012, Medical Devices.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.)Two Electrode Probes:Dimensions (in.) | Pen-shaped ~0.5" to ~1.04" Dia.,Length ~6.27"0.118in Dia., 0.157in, Center to center spacing | Fits in the palm of patient's hand | |
| Patient ContactingMaterials | Tip Assembly with Electrodes:• Lustran 348 WT012002 (ABS)• Clariant SB7M665060, GREY• 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(Proposed Device) | CEDETA Mk2(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(See Detailed Description) | Continuous Pure Biphasic Sinusoidal withzero DC offset | |
| Shape (e.g., rectangular, spike, rectified sinusoidal) | Rectangular | Sinusoidal | |
| Pole Configuration (e.g., 2-pole, 4-pole) – Forinterferential 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 | 130cps | |
| Slow Frequency Pulse Duration | 1Hz | 3.85ms | |
| For multiphasicwaveforms only: | Symmetrical phases? | Yes | Yes |
| Phase Duration (include units),(state range, if applicable), (bothphases, if asymmetrical) | 0.999s | 3.85ms | |
| Net Charge (microcoulombs (μC) per cycle) (If zero,state method of achieving zero net charge.) | 0μC. Positive current through theload for 0.999s, then negative goingcurrent for 0.999s and repeat | 0μC, for 3.85ms signal is positive going andfor 3.85ms is negative going, because of thesinusoidal shape | |
| Description | Dental Pain Eraser(Proposed Device) | CEDETA Mk2(Predicate Device) | |
| Maximum Phase Charge (µC) | 2.77µC @ 1kΩ | 96.25µC @ 1kΩ | |
| Maximum Current Density (mA/cm², r.m.s.) | 68.5mA/cm²@1kΩ, assuming 4mm²electrode contact area | 31.85mA/cm² @ 1kΩ | |
| Maximum Average Current (average absolutevalue - mA) | 0mA @ 1kΩ | 0mA @ 1kΩ | |
| Maximum Average Power Density (W/cm²), (usingsmallest electrode conductive surface area) | 0.187W/cm² @ 1kΩ | 0.398W/cm² @ 1kΩ | |
| Burst Mode(i.e., pulse trains): | (a) Pulses per burst | 15 | Continuous Pure biphasic sinusoidalwaveform with 7.7ms period |
| (b) Bursts per second | 333 | 130 | |
| (c) Burst duration (seconds) | 3ms | 7.85ms | |
| (d) Duty Cycle: Line (b) x Line (c) | 0.999s | 1.025s | |
| ON Time (seconds) | 0.2498s | Continuous | |
| OFF Time (seconds) | 0.7493s | None | |
| Additional Features (specify, if applicable) | Device can be turned off by the useror it turns off automatically after 5min, whichever time is shortest | Power is patient controlled via tinglingsensation |
Table 1: Substantial Equivalence Table
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Table 1: Substantial Equivalence Table (Cont.)
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Table 1: Substantial Equivalence Table (Cont.)
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Table 1: Substantial Equivalence Table (Cont.)
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Table 2: Comparison of Output Specifications
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Table 2: Comparison of Output Specifications (Cont.)
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PERFORMANCE DATA [807.92(b)]
All necessary bench and clinical testing was conducted on the Dental Pain Eraser to support a determination of substantial equivalence to the predicate device.
[807.92(b)(1)]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. Table 3 presents the results of this testing
| Biological Effect Category /Test Description | Standard | Result |
|---|---|---|
| Cytotoxicity | Biological evaluation of Medical Devices Part 5: Tests forIn Vitro Cytotoxicity (ISO 10993-5: 2009) | Pass |
| Sensitization/0.9% SodiumChloride Injection Extract | Biological evaluation of medical devices Part 10: Tests forirritation and skin sensitization (ISO 10993-10:2010) | Pass |
| Sensitization/Skin Sesame oil Extract | Biological evaluation of medical devices Part 10: Tests forirritation and skin sensitization (ISO 10993-10:2010) | Pass |
| Irritation/0.9% SodiumChloride Injection Extract | Biological evaluation of medical devices Part 10: Tests forirritation and skin sensitization (ISO 10993-10:2010) | Pass |
| Irritation/ Sesame Oil Extract | Biological evaluation of medical devices Part 10: Tests forirritation and skin sensitization (ISO 10993-10:2010) | Pass |
Table 3: Biocompatibility Test Results
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. In addition, the collective bench testing demonstrates that the Dental Pain Eraser does not raise different questions of safety or effectiveness for alleviation of oral pain when compared to the predicate device.
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[807.92(b)(2)] Clinical Testing Summary:
Three clinical studies have been performed to evaluate the clinical performance of the Dental Pain Eraser:
- . 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
- 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
- CSP-TENS-001, Preliminary Pilot Study Done by Doctor Cosmo Haralambidis at . Cranston Orthodontics, 59 Phenix Ave Cranston, RI, United States 02920
CSP-TENS-002
In CSP-TENS-002, patients were selected during the leveling and aligning phase of orthodontic treatment and that exhibited a level of crowding described as moderate to severe. Patients who were experiencing immediate orthodontic pain following orthodontic adjustment were selected. Baseline demographic information collected included the age and sex of each patient. 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. Safety of the device was demonstrated as no adverse device effects were reported.
CSP-TENS-003
CSP-TENS-003 was a randomized controlled trial conducted to evaluate the effectiveness of the Dental Pain Eraser on alleviating tooth pain after orthodontic separator placement. Baseline demographic information collected included the age and sex of each patient. Patients were randomly assigned to one of three treatment groups. For all three treatment groups, elastic separators were placed mesial/distal to the maxillary and mandibular first molars using floss or a separator plier. For Group 1 (Experimental Group), the Dental Pain Eraser was activated on the affected area for approximately ten seconds. For Group 2 (Sham Group), the Dental Pain Eraser was placed on the affected area for 10 seconds but not turned on, no stimulation occurred. For Group 3 (Control Group) the Dental Pain Eraser was not to be used on patients assigned to this group. All patients in all three groups completed the same pain assessment questionnaires. 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. Safety of the device was demonstrated as no adverse device effects were reported.
CSP-TENS-001
CSP-TENS-001 studied patients with periodontal pain associated with orthodontic appliance adjustment. Baseline demographic information collected included the age and sex of each patient. The study suggests that the Dental Pain Eraser alleviates post orthodontic appliance adjustment tooth pain. No adverse device effects were reported in this study.
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CONCLUSIONS [807.92(b)(3)]
Extensive nonclinical and clinical 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 exhibits the required mechanical and functional characteristics for its intended use in alleviating pain and as such is substantially equivalent to the predicate device. The Dental Pain Eraser is substantially equivalent to the predicate device.
N/A