← Product Code [ELC](/submissions/DE/subpart-e%E2%80%94surgical-devices/ELC) · K240707
# Ultrasonic Scaler (WD-JY-B002,WD-JY-W001,WD-JY-R003,WD-JY-G004,WD-JY-B003,WD-JY-C006,WD-JY-M0014, WD-JY-N0015,WD-JY-N0016,WD-JY-N0017,WD-JY-E007, WD-JY-F008,WD-JY-A005,WD-JY-H009,WD-JY-I0011, WD-JY-K0012,WD-JY-K0013,WD-JY-K0014, WD-JY-L0013,WD-JY-L0014,WD-JY-L0015, WD-JY-L0016,WD-JY-L0017) (K240707)
_Shenzhen Micro Electric Intelligence Co., Ltd. · ELC · Jul 2, 2024 · Dental · SESE_
**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/ELC/K240707
## Device Facts
- **Applicant:** Shenzhen Micro Electric Intelligence Co., Ltd.
- **Product Code:** [ELC](/submissions/DE/subpart-e%E2%80%94surgical-devices/ELC.md)
- **Decision Date:** Jul 2, 2024
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.4850
- **Device Class:** Class 2
- **Review Panel:** Dental
- **Attributes:** Therapeutic
## Intended Use
Ultrasonic Scaler is used to remove dental plaque from teeth and remove stains on teeth during dental cleaning.
## Device Story
Ultrasonic Scaler is a dental device used for plaque and stain removal. It consists of an electronic oscillation circuit that generates ultrasonic frequency electric pulse waves. These pulses are amplified and transmitted to a transducer, converting electrical energy into mechanical energy. This mechanical vibration is delivered to a working head (scaler tip) to crush calculus and loosen tartar. The device is intended for use by dental professionals during cleaning and periodontal therapy. The operator controls the device, and output is monitored via an external display driver circuit with LED indicators. The device aids in reducing tooth decay and cleaning gingival areas. Benefits include efficient removal of adherent plaque and food debris from teeth and gingival lines.
## Clinical Evidence
Bench testing only. No clinical data provided. Performance verified through electrical safety, EMC, and biocompatibility testing (ISO 10993-5, ISO 10993-10, ISO 10993-23). Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 62471, and IEC 80601-2-60 confirmed.
## Technological Characteristics
Ultrasonic transducer-based mechanical vibration; 3.7VDC power supply; 2.8W output power. Biocompatibility per ISO 10993-5 and ISO 10993-10. Electrical safety per IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 62471, and IEC 80601-2-60. LED-based display mode. Cleaning method involves boiling water.
## Regulatory Identification
An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.
## Predicate Devices
- Ultrasonic scaler ([K163414](/device/K163414.md))
## Submission Summary (Full Text)
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July 2, 2024
Shenzhen Micro Electric Intelligence Co., Ltd. Fengmeng Han General Manager 301, Building A5, No. 13 Baonan Road, Longgang Community Longgang District Shenzhen, Guangdong 518100 CHINA
Re: K240707
Trade/Device Name: Ultrasonic Scaler (WD-JY-B002,WD-JY-W001,WD-JY-R003,WD-JY-G004.WD-JY-B003.WD-JY-C006.WD-JY-M0014. WD-JY-N0015.WD-JY-N0016.WD-JY-N0017.WD-JY-E007. WD-JY-F008.WD-JY-A005.WD-JY-H009,WD-JY-I0011, WD-JY-K0012,WD-JY-K0013,WD-JY-K0014, WD-JY-L0013,WD-JY-L0014,WD-JY-L0015, WD-JY-L0016,WD-JY-L0017) Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: Class II Product Code: ELC Dated: June 3, 2024 Received: June 3, 2024
Dear Fengmeng Han:
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 (the 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 available 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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).
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Sincerely,
# Michael E. Adjodha -S
Michael E. Adjodha, MChE, RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT 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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## Indications for Use
510(k) Number (if known) K240707
#### Device Name
Ultrasonic Scaler (WD-JY-B002,WD-JY-R003,WD-JY-R003,WD-JY-G003,WD-JY-C006,WD-JY-M0014, WD-JY-N0015,WD-JY-N0016,WD-JY-N0017,WD-JY-E007, WD-JY-F008,WD-JY-H009,WD-JY-I0011, WD-JY-K0012,WD-JY-K0013,WD-JY-K0014, WD-JY-L0013,WD-JY-L0015, WD-JY-L0015, WD-JY-L0016,WD-JY-L0017)
#### Indications for Use (Describe)
Ultrasonic Scaler is used to remove dental plaque from teeth and remove stains on teeth during dental cleaning.
| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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# K240707_510(k) summary
#### Submitter l
### Device Submitter
Shenzhen Micro Electric Intelligence Co., Ltd.
301, Building A5,No. 13 Baonan Road, Longgang Community, Longgang District, Shenzhen
### Contact Person
FANGMENG HAN General Manager Phone: 86-755-23310679 E-mail: 360721873@qq.com Prepare Date: July 1, 2024
#### Device =
| Trade Name of Device: | Ultrasonic Scaler |
|-----------------------|--------------------|
| Common Name | Ultrasonic Scaler |
| Regulation Number: | 21 CFR 872.4850 |
| Regulation Name: | Scaler, Ultrasonic |
| Regulatory Class: | II |
| Product code: | ELC |
| Review Panel: | Dental |
# III Predicate Devices
| 510(k) Number | K163414 |
|--------------------|----------------------------|
| Device Name | Ultrasonic scaler |
| Manufacturer | NANNING VV DENTAL CO., LTD |
| Regulation Number: | 21 CFR 872.4850 |
| Regulatory Class: | II |
| Product code: | ELC |
| Review Panel: | Dental |
# IV Device description
A device intended for use during dental cleaning and periodontal (gum) therapy to remove adherent plaque and food debris from the teeth to reduce tooth decay, potential stains in the gingival groove, the back of the tooth and the tooth and associated gingival line.
The electronic oscillation circuit generates ultrasonic frequency electric pulse wave, which is amplified to a certain intensity and conveyed to the transducer. The electrical energy is
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converted into mechanical energy, and the working head tool is stimulated to produce vibration of the same frequency, so as to achieve the purpose of crushing calculus and loosening tartar.
#### > Indications for use
Ultrasonic Scaler is used to remove dental plaque from teeth and remove stains on teeth during dental cleaning.
# VI Comparison of technological characteristics with the predicate devices
The Ultrasonic Scaler has the same intended use, technology, design and performance specifications are either identical or substantially equivalent to existing legally marketed predicate devices. The differences between the Ultrasonic Scaler and predicate devices do not alter suitability of the proposed device for its intended use.
| Item | Proposed Device | Predicate Device
(K163414) | Comparison |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Manufacturer | Shenzhen Micro Electric
Intelligence Co., Ltd. | NANNING VV DENTAL
CO., LTD. | / |
| Regulation No. | 21 CFR 872.4850 | 21 CFR 872.4850 | Identical |
| Class | II | II | Identical |
| Product Code | ELC | ELC | Identical |
| Indication for
use | Ultrasonic Scaler is used
to remove dental plaque
from teeth and remove
stains on teeth during
dental cleaning. | The ultrasonic scaler is
intended to:
1. Remove supra and sub
gingival calculus
deposits and stain from
the teeth;
2. Carry out periodontal
pocket lavage with
simultaneous ultrasonic tip
movement;
3. Clean and irrigate root
canals | Identical |
| Operation
Controls | Cleaning and disinfection
method of tooth cleaning
tip: after each use, scald | Scaler tip: autoclaved
under high temperature and
high pressure | Different |
| Item | Proposed Device | Predicate Device
(K163414) | Comparison |
| | the tooth cleaning tip with
boiling water for five
minutes, then wipe it dry
and store it for next use | | |
| Display Modes | Corresponding signal of
external display driver
circuit lights up
corresponding LED. | Corresponding signal of
external display driver
circuit lights up
corresponding LED. | Identical |
| Measurement
Items | remove adherent plaque
from the teeth and
potential stains in the
gingival groove, the back
of the tooth and the tooth
and associated
gingival line. | Remove calculus or plaque
on surface of teeth in oral
cavity, cleaning and
irrigation of root canals. | Similar |
| Power Supply | Input Voltag: 3.7VDC 50HZ
Output Power: 2.8W | Input Voltage: 30VDC 50HZ
Output Power: 3-20W | Different |
| Operating
conditions | Temperature: 0-35°C
Relative Humidity:
<80%R.H
Pressure: 70-106kpa | Temperature: 5°C-40°C
Relative Humidity: 30%--
80%
Pressure: 50kpa-106kpa | Different |
| Storage
conditions | Temperature: 0°C - +40°C
Relative Humidity:
<80%R.H.
Pressure: 70-106kpa | Temperature: -10°C -+50°C
Relativehumidity: ≤ 80%
Pressure: 50kpa-106kpa | Different |
| Tips of
ultrasonic
scaler | Mechanical vibration
transmitted from the
handpiece is converted to
the vibration of the scaler
tip, then removes calculus
or plaque from the teeth. | Mechanical vibration
transmitted from the
handpiece is converted to
the vibration of the scaler
tip, then
removes calculus or plaque
from the
teeth | Different |
| Item | Proposed Device | Predicate Device
(K163414) | Comparison |
| Electrical
Safety | IEC 60601-1 | IEC 60601-1 | Identical |
| EMC | IEC 60601-1-2 | IEC 60601-1-2 | Identical |
| Performnce | IEC 60601-1-11 | IEC 61205 | Different |
| Biocompatibility | ISO 10993-5, ISO 10993-
10 | ISO 10993-5, ISO 10993-
10 | Identical |
| Software Level
of Concern | Moderate | Moderate | Identical |
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510(k) Summary
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### Discussion
Similarities:
Measurement Items is similar.
Proposed Device: remove adherent plaque and food debris from the teeth to reduce tooth decay, potential stains in the gingival groove, the back of the tooth and the tooth and associated gingival line.
Predicate Device: Remove calculus or plaque on surface of teeth in oral cavity, cleaning and irrigation of root canals.
## Difference:
Design:Operation Controls, Power Supply, Operating conditions and Storage conditions is slight different. However, Proposed Device has passed the Electrical Safety and EMC tests. Performance: the requirement of performance standards is slight different. However, Proposed Device has passed the performance test.
- The difference does not raise additional questions for safety and effectiveness. . Performance testing including biocompatibility evaluation has been performed on the final finished device which includes all construction materials and color additives.
In conclusion, there is no substantial difference between our products and similar products currently marketed in the United States.
# VII Performance data
The following performance data were provided in support of the substantial equivalence determination.
# Biocompatibility testing
Biocompatibility of the Ultrasonic Scaler was evaluated in accordance with ISO 10993-1:2018 for the body contact category of "Surface Device - Mucosal Membrane" with a contact duration of "Limited (< 24 hours)". The following tests were performed, as recommended: Cytotoxicity ISO 10993-5: 2009
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Skin sensitization Intracutaneous reactivity
ISO 10993-10: 2021 ISO 10993-23: 2021
Non-Clinical Testing:
A battery of tests was performed to verify that the proposed device met all design specification. The test result demonstrated that the proposed device complies with the following standards: Electrical safety and electromagnetic compatibility
IEC 60601-1:2005 + AMD1:2012 + AMD2:2020 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2:2015 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance-Collateral Standard: Electromagnetic disturbances -Requirements and tests
IEC 60601-1-11:2015+AMD1:2020 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
IEC 62471:2006 Photobiological safety of lamps and lamp systems
IEC 80601-2-60:2019 Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment
#### VIII Conclusion
Conclusions drawn from non-clinical trials indicate that the subject device is as safe and effective as the legally marketed predicted K163414 ultrasonic scale and performs as well or better than the K163414 ultrasonic scaler.
---
**Source:** [https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/ELC/K240707](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/ELC/K240707)
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