← Product Code LWM · K193570
# Dental Pain Eraser (K193570)
_Synapse Dental · LWM · Jan 17, 2020 · DE · SESE_
**Canonical URL:** https://fda.innolitics.com/device/K193570
## Device Facts
- **Applicant:** Synapse Dental
- **Product Code:** LWM
- **Decision Date:** Jan 17, 2020
- **Decision:** SESE
- **Submission Type:** Special
- **Device Class:** Class U
- **Review Panel:** DE
- **Attributes:** Therapeutic, Pediatric
## 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.
## Device Story
Non-invasive TENS device; pen-shaped; two metal electrodes replace toothbrush bristles. Used in dental/orthodontic facilities by professionals. Device turned on for 30 seconds to 10 minutes; electrodes rubbed on gums near aching tooth or skin around canker sore. Electrical current flows between electrodes through tissue to anesthetize nerves; alleviates oral pain. Benefits patient by providing temporary pain relief during/after procedures. Multi-use device requiring cleaning/disinfection between patients.
## Clinical Evidence
No clinical data. Substantial equivalence established via bench testing, including cleaning/disinfection validation, cycle testing, and tip assembly pull testing.
## Technological Characteristics
TENS device; pen-shaped; 303 stainless steel electrodes; ABS plastic housing. Powered by three 393/309 silver oxide button cells. Output: complex, biphasic, charge-neutral waveform (10kHz). IP21 ingress protection. Compliant with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 62304, ANSI/AAMI NS4, ISO 7405, ISO 10993-1, IEC 62366-1, and ISO 14971.
## Predicate Devices
- Dental Pain Eraser DPE-C300 ([K182947](/device/K182947.md))
## Submission Summary (Full Text)
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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
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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
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# 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)]
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
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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)]
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.
#### 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).
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).
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# 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 ●
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 [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.
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| 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) |
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| | | Rationale for Substantial Equivalence | | | | | | | | | | | | | |
|------------------------------------------------|------------------------------------------------------|---------------------------------------|-------------------------|-------------------------------|----------------------------------------------------------------------------------------------|------------------------|---------------------------|-------------------------------|-------------------------------|-----------------------------------------|-------------------------------------------|--------------------------|-------------------------|---------------------|--|
| | Dental Pain Eraser
DPE-C300
(Predicate Device) | DC ~ 0μA AC<10mA | DC~0μA AC<10mA | 0μA | 1
(As requested per Q180245, see Table 2 for
the Output Specifications) | 2 | Alternating | Not isolated | Voltage | Firmware | No | No | Yes | N/A (same) | |
| | Dental Pain Eraser
DPE-C300
(Proposed Device) | DC ~ 0μA AC<10mA | DC~0μA AC<10mA | 0μA | 1
(As requested per Q180245, see Table 2 for
the Output Specifications) | 2 | Alternating | Not isolated | Voltage | Firmware | No | No | Yes | N/A (same) | |
| Table 1: Substantial Equivalence Table (Cont.) | Characteristic | Patient Leakage Current | ○ Normal Condition (μA) | ○ Single Fault Condition (μA) | Average DC current through electrodes when device is on but no pulses are being applied (μA) | Number of Output Modes | Number of Output Channels | • Synchronous or Alternating? | • Method of Channel Isolation | Regulated Current or Regulated Voltage? | Software/Firmware/Microprocessor Control? | Automatic Overload Trip? | Automatic No-Load Trip? | Automatic Shut Off? | |
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| Characteristic | Dental Pain Eraser
DPE-C300
(Proposed Device) | Dental Pain Eraser
DPE-C300
(Predicate Device) | Rationale for Substantial Equivalence |
|--------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Indicator Display
On/Off Status? | Yes | Yes | N/A (same) |
| Low Battery? | No | No | N/A (same) |
| Voltage/Current Level? | No | No | N/A (same) |
| Therapy Range (minutes) | 5 minutes Max | 5 minutes Max | N/A (same) |
| Compliance with Voluntary
Standards | Compliant with applicable requirements of:
IEC 60601-1, IEC 60601-1-2, IEC 60601-2-
10, IEC 62304
ANSI/AAMI NS4:2013, Transcutaneous
Electrical Nerve Stimulators
ISO 7405: Second edition 2008-12-15,
Dentistry - Evaluation of biocompatibility of
medical devices used in dentistry [Including:
Amendment 1 (2013)].
ISO 10993-1:2009, Biological evaluation of
medical devices - Part 1: Evaluation and
testing within a risk management process | Compliant with applicable requirements of:
IEC 60601-1, IEC 60601-1-2, IEC 60601-2-
10, IEC 62304
ANSI/AAMI NS4:2013, Transcutaneous
Electrical Nerve Stimulators
ISO 7405: Second edition 2008-12-15,
Dentistry - Evaluation of biocompatibility of
medical devices used in dentistry [Including:
Amendment 1 (2013)].
ISO 10993-1:2009, Biological evaluation of
medical devices - Part 1: Evaluation and
testing within a risk management process | |
| Table 1: Substantial Equivalence Table (Cont.) | | | K193570 |
| | Dental Pain Eraser
DPE-C300
(Proposed Device) | Dental Pain Eraser
DPE-C300
(Predicate Device) | |
| Characteristic | | | Rationale for Substantial Equivalence |
| Compliance with Voluntary
Standards (continued) | IEC 62366-1:2015, Medical devices. Part 1:
Application of usability engineering to
medical devices
ISO 14971:2012, Medical Devices.
Application of Risk Management to Medical
Devices | IEC 62366-1:2015, Medical devices. Part 1:
Application of usability engineering to
medical devices
ISO 14971:2012, Medical Devices.
Application of Risk Management to Medical
Devices | N/A (same) |
| Compliance with 21 CFR Part
898? | Not applicable | Not applicable | |
| Weight (oz.) | 0.423oz | 0.423oz | N/A (same) |
| Unit Body Dimensions (in.)
Two Electrode Probes:
Dimensions (in.) | Pen-shaped ~0.5" to ~1.04" Diameter,
Length ~6.27"
0.118" Diameter, 0.157", Center to center
spacing | Pen-shaped ~0.5" to ~1.04" Diameter,
Length ~6.27"
0.118" Diameter, 0.157", Center to center
spacing | N/A (same) |
| Materials and Construction | | | |
| Patient Contacting Materials
Within the Mouth | Tip Assembly with Electrodes:
• Lustran 348 WT012002 (ABS)
• Clariant SB7M665060, GREY
• 303 Stainless Steel | Tip Assembly with Electrodes:
• Lustran 348 WT012002 (ABS)
• Clariant SB7M665060, GREY
• 303 Stainless Steel | N/A (same) |
| 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. | 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. | |
| Ingress Protection Rating | IP21 | IP21 | N/A (same) |
| | Description | Dental Pain Eraser
DPE-C300
(Proposed Device) | Dental Pain Eraser
DPE-C300
(Predicate Device) |
| Mode or Program Name | | Only one Mode | Only one Mode |
| Indication for Use | | Pulsing Light | Pulsing Light |
| Waveform (e.g., pulsed monophasic, biphasic) | | Complex, Biphasic, Charge Neutral (See Detailed Description) | Complex, Biphasic, Charge Neutral (See Detailed Description) |
| Shape (e.g., rectangular, spike, rectified sinusoidal) | | Rectangular | Rectangular |
| Pole Configuration (e.g., 2-pole, 4-pole) - For interferential
current only | | NA | NA |
| Maximum Output Voltage (V) (+/- 10%) | | 2.08@ 500Ω
2.74@ 1kΩ
4.24@ 10kΩ | 2.08@ 500Ω
2.74@ 1kΩ
4.24@ 10kΩ |
| Maximum Output Current (mA) (+/-10%) | | 4.16@ 500Ω
2.74@ 1kΩ
0.42@ 10kΩ | 4.16@ 500Ω
2.74@ 1kΩ
0.42@ 10kΩ |
| Duration of primary (depolarizing) phase (ms) | | | |
| High Frequency Pulse duration (μs) | | 50μs on, 50μs off | 50μs on, 50μs off |
| High Frequency (Hz) [or Rate (pps)] | | 10kHz | 10kHz |
| Slow Frequency Pulse Duration | | 1Hz | 1Hz |
| For multiphasic
waveforms only: | Symmetrical phases? | Yes | Yes |
| | Phase Duration (include units), (state
range, if applicable), (both phases, if
asymmetrical) | 0.999s | 0.999s |
| | Net Charge (microcoulombs (μC) per cycle) (If zero, state
method of achieving zero net charge.) | 0μC. Positive current through the load for
0.999s, then negative going current for
0.999s and repeat. | 0μC. Positive current through the load for
0.999s, then negative going current for
0.999s and repeat. |
| Table 2: Comparison of Output Specifications (Cont.) | | | |
| | Description | Dental Pain Eraser
DPE-C300
(Proposed Device) | Dental Pain Eraser
DPE-C300
(Predicate Device) |
| | Maximum Phase Charge (μC) | 2.77μC @ 1kΩ | 2.77μC @ 1kΩ |
| | Maximum Current Density (mA/cm², r.m.s.) | 68.5mA/cm² @ 1kΩ, assuming 4mm²
electrode contact area | 68.5mA/cm² @ 1kΩ, assuming 4mm²
electrode contact area |
| | Maximum Average Current (average absolute
value - mA) | 0mA @ 1kΩ | 0mA @ 1kΩ |
| | Maximum Average Power Density (W/cm²), (using smallest
electrode conductive surface area) | 0.187W/cm² @ 1kΩ | 0.187W/cm² @ 1kΩ |
| | Burst Mode
(i.e., pulse trains):
(a) Pulses per burst | 15 | 15 |
| | (b) Bursts per second | 333 | 333 |
| | (c) Burst duration (seconds) | 3ms | 3ms |
| | (d) Duty Cycle: Line (b) x Line (c) | 0.999s | 0.999s |
| | ON Time (seconds) | 0.2498s | 0.2498s |
| | OFF Time (seconds) | 0.7493s | 0.7493s |
| | Additional Features (specify, if applicable) | Device can be turned off by the user or it
turns off automatically after 5 minutes,
whichever time is shortest | Device can be turned off by the user or it
turns off automatically after 5 minutes,
whichever time is shortest |
K193570
# 0(k) SUMMARY (CONT
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K193570
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10(k) SUMMARY (CONT
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**Source:** [https://fda.innolitics.com/device/K193570](https://fda.innolitics.com/device/K193570)
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