(109 days)
Not Found
No
The description focuses on the electronic oscillation circuit and mechanical vibration for calculus removal, with no mention of AI/ML terms or data processing for learning.
Yes
The device is used to remove dental plaque and stains, and to crush calculus and loosen tartar. These actions are intended to treat or alleviate dental conditions and contribute to overall oral health, which aligns with the definition of a therapeutic device.
No
The device description states it is used to remove dental plaque, food debris, and calculus, which are treatment or cleaning functions, not diagnostic ones.
No
The device description explicitly details hardware components like an electronic oscillation circuit, transducer, and working head tool, and the performance studies include biocompatibility and electrical safety testing, indicating it is a physical device with electrical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices 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 description clearly states the device is an "Ultrasonic Scaler" used to "remove dental plaque from teeth and remove stains on teeth during dental cleaning." It works by generating ultrasonic vibrations to physically remove material from the teeth.
- Lack of Specimen Analysis: The device does not analyze any biological specimens taken from the body. It directly interacts with the teeth and surrounding tissues.
- Intended Use: The intended use is for dental cleaning and periodontal therapy, which are procedures performed directly on the patient's oral cavity, not on in vitro samples.
Therefore, the function and intended use of this Ultrasonic Scaler fall outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Ultrasonic Scaler is used to remove dental plaque from teeth and remove stains on teeth during dental cleaning.
Product codes
ELC
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth, gingival groove
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Non-clinical performance data was provided. Biocompatibility testing was performed in accordance with ISO 10993-1:2018 for "Surface Device - Mucosal Membrane" contact of "Limited (
§ 872.4850 Ultrasonic scaler.
(a)
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.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services. To the right of the symbol, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" above the word "ADMINISTRATION". The logo is simple and professional, reflecting the FDA's role in regulating food and drugs.
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
3
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
5
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:
- Remove supra and sub
gingival calculus
deposits and stain from
the teeth; - Carry out periodontal
pocket lavage with
simultaneous ultrasonic tip
movement; - 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: