Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on piezoelectric technology and basic electronic circuits for generating ultrasonic vibrations. There is no mention of AI, ML, image processing, or data-driven algorithms.

Therapeutic

Yes
The device is used for medical purposes such as removing calculus deposits, cleaning root canals, and performing periodontal pocket lavage. These are therapeutic interventions aimed at treating dental conditions.

Diagnostic

No

Explanation: The device is an ultrasonic scaler, designed to remove calculus and clean teeth/root canals. Its intended uses are therapeutic/interventional in nature (removing deposits, lavage, cleaning), not to diagnose a condition or disease.

SaMD (Software as a Medical Device)

No

The device description clearly outlines multiple hardware components including a control unit, generator, handpiece, scaler tips, power adapter, and foot switch. It is a physical device that uses piezoelectric technology.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
Device Function: The ultrasonic scaler described is used directly on the patient's teeth and root canals to remove calculus and clean. This is an in vivo procedure (performed within the living body).
Intended Use: The intended uses clearly describe procedures performed directly in the mouth.
Device Description: The components and function relate to generating ultrasonic vibrations for mechanical action on teeth, not for analyzing biological samples.
Performance Studies: The non-clinical testing focuses on electrical safety, electromagnetic compatibility, ultrasonic output characteristics, and biocompatibility with tissues, all relevant to a device used directly on a patient. There are no studies related to analyzing biological samples.

Therefore, based on the provided information, the ultrasonic scaler is a medical device used for dental procedures in vivo, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The ultrasonic scaler is intended to:

1. Remove supra and sub gingival calculus deposits and stain from the teeth;
1. Carry out periodontal pocket lavage with simultaneous ultrasonic tip movement;
1. Clean and irrigate root canals

Product codes (comma separated list FDA assigned to the subject device)

ELC

Device Description

The Ultrasonic scaler employs piezoelectric technology to produce a steady power. It is composed of a control unit housing a generator that produces piezo-electric vibrations. The working instrument for the ultrasonic scaler is the handpiece, which is connected to the control unit via a handpiece cord. A scaling tip specific to a particular procedure is attached to the end of the handpiece. The ultrasonic scaler models VET-W3 and VST-W3 connect to an external water supply and delivers water via connected handpiece.

Ultrasonic scaler consists of main generator, VE and VS handpiece, optional scaler tips (G series, P series, E series), power adapter and foot switch;

The main part is as follows:

1. Power adapter: DC 24V, input frequency: 3-20W
1. Main engine: The main engine is the major part of the circuit control, including ultrasonic pulse circuit, modulator circuit and oscillatory circuit. It is used for converting the ultrasonic oscillatory signal to ultrasonic mechanical oscillatory signal by magnifying and improving the vibrating frequency.
1. Handpiece: It mainly converts the signal from circuit,which will drive the ultrasonic scaler tips vibrating.
1. Scaler tip: The scaler tip is used to remove the calculus and plague by vibrating on the teeth surface.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

teeth, periodontal pocket, root canals

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical Testing:
The following bench testing was conducted in order to support substantial equivalence of the proposed device:

IEC 60601-1:2006+A1:2012 medical electrical equipment -- part 1: general ● requirements for basic safety and essential performance
. IEC 60601-1-2:2007 medical electrical equipment - part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic compatibility - requirements and tests.
IEC 61205:2001 Ultrasonics-Dental descaler systems-Measurement and declaration of the output characteristics.
. ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
. ISO 10993-10:2010 Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization.

Clinical Testing:
Clinical evaluation is not applicable for the proposed device.

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.

K140233

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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 21, 2017

Nanning Vv Dental Co., Ltd. Liang Chaojun Vice General Manager 4th Floor,north Bld. No.1 , Zhengxin Tech Zone, No. 2, Gaoxin 7 Rd. Nan Ning, 530007 CN

Re: K163414

Trade/Device Name: Ultrasonic Scaler Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: Class II Product Code: elc Dated: October 25, 2017 Received: October 27, 2017

Dear Liang Chaojun:

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. 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

1

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

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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) K163414

Device Name

Ultrasonic Scaler

Indications for Use (Describe)

The ultrasonic scaler is intended to:

1. Remove supra and sub gingival calculus deposits and stain from the teeth;
1. Carry out periodontal pocket lavage with simultaneous ultrasonic tip movement;

3.Clean and irrigate root canals

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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K163414 510(k) SUMMARY

(As Required by 21 CFR 807.92)

1. Date Prepared October 2nd, 2017

2. Submitter;s Information

Company Name:	NANNING VV DENTAL CO., LTD.
Company Address:	4th floor,North Bld. No.1, Zhengxin Tech Zone
	No. 2, Gaoxin 7 Rd., Nanning, China 530007
Fax:	0086-771-580-1312

3. Device Information

Trade Name:
Models:
Product Code:
Regulation Number:
Device Class:

Ultrasonic Scaler VET-W3, VST-W3, VET-1 and VST-1 ELC 21 CFR 872.4850 Class II

4. Identification of Predicate Devices

Predicate I

Manufacturer:	Nanning Baolai Medical Instruments Co., Ltd.
Trade Name:	Ultrasonic scaler P7
Product Code:	ELC
Classification Name:	Ultrasonic Scaler
Regulation Number :	21 CFR 872.4850
FDA 510 (k) #:	K140233

5. Description of the Device

The Ultrasonic scaler employs piezoelectric technology to produce a steady power. It is composed of a control unit housing a generator that produces piezo-electric vibrations. The working instrument for the ultrasonic scaler is the handpiece, which is connected to the control unit via a handpiece cord. A scaling tip specific to a particular procedure is attached to the end of the handpiece. The ultrasonic scaler models VET-W3 and VST-W3 connect to an external water supply and delivers water via connected handpiece.

[510(k)] Application

SECTION 7 - 1 of 5

4

Ultrasonic scaler consists of main generator, VE and VS handpiece, optional scaler tips (G series, P series, E series), power adapter and foot switch;

The main part is as follows:

1. Power adapter: DC 24V, input frequency: 3-20W

Main engine: The main engine is the major part of the circuit control, including ultrasonic pulse circuit, modulator circuit and oscillatory circuit. It is used for converting the ultrasonic oscillatory signal to ultrasonic mechanical oscillatory signal by magnifying and improving the vibrating frequency.
Handpiece: It mainly converts the signal from circuit,which will drive the ultrasonic scaler tips vibrating.
Scaler tip: The scaler tip is used to remove the calculus and plague by vibrating on the teeth surface.

6. Indications For Use

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

7. Technological Characteristics

The ultrasonic scaler is powered by the piezoelectric technology, which is also employed by the predicate device. The electric power is transduced into high- frequency vibration via an ultrasonic transducer. The proposed ultrasonic scaler connects to an external water supply and delivers water via connected handpiece.

| Items | K163414 Proposed Device | K140233 Predicate Device
Ultrasonic scaler P7 |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
For Use | The ultrasonic scaler is intended to:
1.Remove supra and sub gingival
calculus deposits and stain from
the teeth; | 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. | 2. Carry out periodontal pocket
lavage with simultaneous
ultrasonic tip movement;
3. Clean and irrigate root canals. |
| Operation
Controls | | |
| | Sterilization:
Handpiece: autoclaved under high
temperature 135°C/pressure 0.22MPa.
Scaler tip: autoclaved under high
temperature and high pressure | Sterilization:
Handpiece: autoclaved
under high temperature 135°C/pressure
0.22MPa. Scaler tip: autoclaved under
high temperature and pressure. |
| Display
Modes | Corresponding signal of external
display driver circuit lights up
corresponding LED. | Corresponding signal of external
display driver circuit lights
up corresponding LED. |
| Measurement
Items | Remove calculus or plaque on surface
of teeth in oral cavity, cleaning and
irrigation of root canals. | Remove calculus or plaque on surface
of teeth in oral cavity, cleaning and
irrigation of root canals. |
| Power
Supply | input voltage : 30VDC 50HZ

output power : 3-20W | input voltage : 24VDC 1.5A 50HZ

8. Substantial Equivalence Table

[510(k)] Application

SECTION 7 - 2 of 5

5

[510(k)] Application

SECTION 7 - 3 of 5

6

The proposed device has same intended use, similar product design, same sterilization condition, safety standards as the predicate device. The slight difference is the power supply, the input voltage of proposed device is 30V DC , the input voltage of predicate device is 15V DC, both of them could meet the electricity safety standard IEC 60601-1, the difference does not affect the substantial equivalence in effectiveness and safety.

Non-clinical Testing:

The following bench testing was conducted in order to support substantial equivalence of the proposed device:

IEC 60601-1:2006+A1:2012 medical electrical equipment -- part 1: general ● requirements for basic safety and essential performance
. IEC 60601-1-2:2007 medical electrical equipment - part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic compatibility - requirements and tests.
IEC 61205:2001 Ultrasonics-Dental descaler systems-Measurement and declaration of the output characteristics.
. ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
. ISO 10993-10:2010 Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization.

Clinical Testing:

Clinical evaluation is not applicable for the proposed device.

9. Conclusion [21 CFR 807.92(b)(3)]

The VET-W3, VST-W3,VET-1 and VST-1 ultrasonic scaler have the same intended use, similar product design, same sterilization conditions and the same technological characteristics as the predicate device. Nonclinical testing further supports the substantial equivalence of the proposed device to its predicate device. Therefore, the proposed device is substantially equivalent to its predicate device.

[510(k)] Application

SECTION 7 - 4 of 5

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