(58 days)
No
The summary describes a mechanical dental handpiece and its operational principles, with no mention of AI or ML capabilities.
No.
The device's intended use and description indicate it is used for mechanical dental procedures such as removing caries, preparing cavities, and finishing tooth preparations, which are procedures rather than therapeutic interventions.
No
The device description and intended use outline its function for mechanical dental procedures (e.g., removing carious material, preparing cavities), not for identifying or analyzing medical conditions or diseases.
No
The device description clearly outlines physical hardware components including a Main Body, Contra Angle, Charging Cradle, and AC/DC Adapter, and describes the mechanical transmission of rotational force.
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 description clearly states that this dental handpiece is used for procedures performed directly on the patient's teeth and surrounding structures (removing carious material, preparing cavities, etc.). This is an in vivo procedure, meaning it's done within the living body.
- Intended Use: The intended use describes direct dental treatment procedures, not laboratory testing of specimens.
Therefore, based on the provided information, the Dental Handpiece, Wireless Endodontic Handpiece, endoit, model no. (EH-C500) is a medical device used for direct patient treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Dental Handpiece, Wireless Endodontic Handpiece, endoit, model no. (EH-C500) is intended for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth preparations, and restorations for polishing teeth.
The Dental Handpiece is designed for use by a trained professional in the field of general dentistry.
Product codes
EKX
Device Description
Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) consists of a Main Body, connectable Contra Angle, Charging Cradle, and AC/DC Adapter. The Main Body of the handpiece is used for transmitting rotational force required in general dental treatment. The torque transmitted from a wireless electric micro-motor gets further transmitted to the joint part of the device. The rotational force is then decelerated according to the speed reducer of the gear which is transmitted to the head of the dental handpiece. The rotational force is transmitted under the permitted rotation mechanism.
The Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) is a wireless, electric, and chargeable device utilized in root canal treatment. The battery inside the Main Body of the proposed Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) generates power to transmit rotational force for the general dental treatments. The speed of the rotation and torque value can be controlled using the buttons on the main body of the device. The rotational force is transmitted under the permitted rotation mechanism.
Components associated with the Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) are the Main Body, Contra Angle (EH-A01), Charging Cradle, and AC/DC Adapter. The Charging Cradle and AC/DC Adapter are accessory components of the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The Dental Handpiece is designed for use by a trained professional in the field of general dentistry.
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
Design Verification and Validation Testing:
The proposed, Micro-NX Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) has been evaluated and risk management practices have been implemented in accordance with ISO 14971:2019/A1:2021 Medical devices - applications of risk management to medical devices.
Tests performed:
- Appearance Test
- Operation Test
- Rotational Speed Test
- Noise Test
- Serviceable Year/ Shelf-Life Test
- IEC 60601-1
- IEC 60601-1-2
Results: The favorable results of the design verification testing demonstrate the design output of Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) conforms to the applicable, pre-determined design requirements of the Dental Handpiece. The testing results also further demonstrate the proposed Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) is substantially equivalent to the predicate (K220577) Dental Handpiece model CA160L, as the proposed and predicate device are subject to the same applicable test standards of design requirements for dental handpieces.
Biocompatibility Testing:
The biocompatibility testing conducted for the predicate device Dental Handpiece model CA 160L (MICRO-NX, K220577) is applicable to the proposed Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500). The proposed Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) is an additional model to the predicate device Dental Handpiece model CA160L (MICRO-NX, K220577). All of the patient-contacting raw materials of the proposed Dental Handpiece. Wireless Endodontic Handpiece, endoit (model number: EH-C500) are the same as the predicate device Dental Handpiece (MICRO-NX, K220577) with no new introduction of patient contacting raw materials for the proposed Dental Handpiece model.
In accordance with ISO 10993-1: 2009. Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process, the Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) is categorized under "Externally Communicating Device-Tissue/bone/dentin (Limited contact duration). This is the same category of the biocompatibility evaluation as the predicate (K220577) Dental Handpiece model CA160L.
The biocompatibility testing has been conducted with the FDA-approved Dental Handpiece model SG200L (K192809) in 2019 in order to ensure FDA's latest consensus standards with respect to biological safety evaluations are met for the proposed device. The predicate (K220577) Dental Handpiece model CA160L was approved by the FDA on July 29th, 2022 and in this submission the Dental Handpiece including model SG200L was used as the predicate device (K192809) for substantial equivalence. The Dental Handpiece model CA160L (K220577) and Dental Handpiece including model SG200L (K192809) were assessed as substantially equivalent and the biocompatibility test results of the Dental Handpiece model SG200L was used as evidence for the Dental Handpiece CA160L (K220577).
Tests performed:
- ISO MEM Elution Using L-929 Mouse Fibroblast Cells (GLP)
- ISO Guinea Pig Maximization Sensitization Test (GLP 2 Extracts)
- ISO Intracutaneous Irritation Test (GLP 2 Extracts)
- ISO Materials Mediated Rabbit Pyrogen (GLP)
- ISO Acute Systemic Injection Test (GLP - 2 Extracts)
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font below.
November 9, 2023
Micro-NX Co., Ltd. % Brandon Green RA Associate K-Bio Solutions 201 South 4th Street, Suite 727 San Jose, California 95112
Re: K232810
Trade/Device Name: Dental Handpiece, Wireless Endodontic Handpiece, endoit Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I, reserved Product Code: EKX Dated: September 4, 2023 Received: September 12, 2023
Dear Brandon Green:
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.
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.
1
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 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) K232810
Device Name
Dental Handpiece, Wireless Endodontic Handpiece, endoit, model no.(EH-C500)
Indications for Use (Describe)
The Dental Handpiece, Wireless Endodontic Handpiece, endoit, model no. (EH-C500) is intended for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth preparations, and restorations for polishing teeth.
The Dental Handpiece is designed for use by a trained professional in the field of general dentistry.
| 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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K232810 510(k) SUMMARY
Pursuant to Section 510(k) of Chapter V of the Federal Food, Drug, and Cosmetic Act and in accordance with subpart E of Part 807, Title 21 of the Code of Federal Regulations, MICRO-NX Co., Ltd. submits the following information as premarket notification for the proposed device, Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500)
I. SUBMITTER
510(k) Correspondent: Brandon Green RA Associate, K-Bio Solutions (brandon.green@kbiotechsolutions.com) Tel: 82-2-597-2700
Sponsor: MICRO-NX Co., Ltd. 22, Maeyeo-ro 1 gil, Dong-gu, Daegu Postal code: 41059, Republic of Korea Tel: 82-053-650-1000 Fax: 82-053-650-1005
Manufacturer Contact: Haim Yoon (haimyoon1@micronx.co.kr) Date Prepared: September 4th, 2023
II. SUBMISSION DEVICE
- Trade Name(s) of Device: Dental Handpiece, Wireless Endodontic Handpiece, ● endoit (model number: EH-C500)
- Regulation Number: 21 CFR 872.4200 ●
- Regulation Name: Dental handpiece and accessories ●
- Product Code: EKX (Handpiece, Direct Drive, Ac-Powered) ●
- Review Panel: Dental
- Regulatory Class: Class I ●
- Traditional 510(k) Registration .
Prior formal correspondence with the FDA resulted in the 510(k) clearance of the Micro-NX Dental Handpiece (K220577) Model CA160, CA160L, and CA500L
III. PREDICATE DEVICES
- Dental Handpiece model CA160L (K220577), Manufacturer: Micro-NX Co., Ltd. ●
- Endo A Class (K123582), Manufacturer: Saeyang Microtech Co., Ltd. ●
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IV. DEVICE DESCRIPTION
The intended use of the proposed Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) is the same as the intended use of the predicate (K220577) Dental Handpiece model CA160L and similar to the predicate (K123582) Endo A Class.
- Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) . is intended for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth preparations, restorations, and for polishing teeth. The Dental Handpiece is designed for use by a trained professional in the field of general dentistry.
- Predicate Dental Handpiece (K220577) model CA160L is intended for the removal of . carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth preparations, restorations, and for polishing teeth. The Dental Handpiece is designed for use by a trained professional in the field of general dentistry.
- . Predicate Endo A Class (K123582) has the following intended use: This application area extends to endodontic procedures using a root canal instrument which is intended by the manufacturer for use in the mechanical and rotary preparation of root canals.
Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) consists of a Main Body, connectable Contra Angle, Charging Cradle, and AC/DC Adapter. The Main Body of the handpiece is used for transmitting rotational force required in general dental treatment. The torque transmitted from a wireless electric micro-motor gets further transmitted to the joint part of the device. The rotational force is then decelerated according to the speed reducer of the gear which is transmitted to the head of the dental handpiece. The rotational force is transmitted under the permitted rotation mechanism.
Compared to the predicate device Dental Handpiece model CA160L (K220577), the Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) contains additional components of a Charging Cradle and AC/DC Adapter. Therefore, the primary distinction between the predicate device (K220577) and the EH-C500 is their power/charging method. The EH-C500 relies on the AC/DC Adapter and Charging Cradle to recharge its Main Body, whereas the predicate (K220577) receives electrical input from an external electric motor that is typically attached to the distal end of the dental handpiece's Main Body. Thus, the main technological characteristics in terms of achieving the intended use for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth preparations, and for polishing teeth are identical between the predicate (K220577) and Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500)
Compared to the predicate device Endo A Class (K123582), the Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) has the same components and similar
6
technological characteristics including a connectable Contra Angle, charging method, and wireless functionality.
The identified difference between the Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) and predicate Dental Handpiece model CA160L (K220577) lies primarily within their power/charging methods. However, this difference has been assessed and it has been determined not to raise different questions regarding the safety or effectiveness of either the predicate devices CA160L and Endo A Class or the proposed device EH-C500, which have been tested according to the FDA's recognized IEC standards listed below:
- . IEC 60601-1 (2005) "Medical electrical equipment - Part 1: General requirements for basic safety and essential performance"
- IEC60601-1-2 (2014) "Edition 4.0 2014-02 Medical electrical equipment Part 1-2: . General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests"
The aforementioned IEC testing of the Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) is provided as eCopy 007 and eCopy 008. Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) is provided with a connectable Contra Angle component, that is connected to the Main Body, The Contra Angle and Main Body of the Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) together make up the main body system of the device. Essentially, the Contra Angle and Main Body of the Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) together serve the similar technological characteristics as the main body system of the predicate (K220577) Dental Handpiece model CA160L. Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) is a wireless, electric, and chargeable device utilized in root canal treatment. The battery inside the Main Body of the proposed Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) generates power to transmit rotational force for the general dental treatments. The speed of the rotation and torque value can be controlled using the buttons on the main body of the device. The rotational force is transmitted under the permitted rotation mechanism.
Components associated with the Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) are the Main Body, Contra Angle (EH-A01), Charging Cradle, and AC/DC Adapter. The Charging Cradle and AC/DC Adapter are accessory components of the device.
Components associated with the predicate Dental Handpiece model CA160L are the Main Body handle which includes Contra Angle. The accessory component associated with the CA160L model is the Spray Adapter.
Components associated with the predicate Endo A Class are the Main Body, Contra Angle, Charging Cradle, and AC/DC Adapter. The Charging Cradle and AC/DC Adapter are accessory components of the device.
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The components of the proposed Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) in comparison of those of the predicate devices Dental Handpiece model CA160L and Endo A Class are provided in Table IV-1 below.
| Model | Proposed Device:
EH-C500 | Predicate Device:
CA160L | Predicate Device:
Endo A Class |
|--------------------------------|-----------------------------|-----------------------------|-----------------------------------|
| Main Body | X | X | X |
| Contra Angle | X | X | X |
| Charging Cradle
(accessory) | X | X | X |
| AC/DC Adapter
(accessory) | X | X | X |
| Spray Adapter
(accessory) | X | X | X |
Table IV-1 Proposed Device Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) Component Specification
The component names and function of the proposed Dental Handpiece. Wireless Endodontic Handpiece, endoit (model number: EH-C500) and predicate Dental Handpiece model CA160L are provided in Table IV-2 and Table IV-3 below.
Table IV-2 Component Names and Functional Descriptions for Critical Components of Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500)
| No. | Component Name | Function |
|---|---|---|
| A. Components of Main Body of the Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) | ||
| A1 | Handpiece Top Case | Top part of the Handpiece case |
| A2 | Handpiece Bottom Case | Bottom part of the Handpiece case |
| A3 | Name plate | Sticker for button identification and exterior design |
| A4 | Button | Button to activate functions of the Dental Handpiece |
| A5 | LCD Plate | Protects LCD |
| A6 | PCB Assembly | Internal PCB |
| A7 | Handle Cap | For connecting internal parts |
| A8 | Index Ring | For connecting internal parts |
| A9 | Motor Assembly | Motor that transmits rotational power |
| A10 | Battery | Power the motor |
| B. Contra Angle (EH-A01) | ||
| B1 | Head Assembly | Transmits rotational power from the handpiece to the bur |
| B2 | Shank Assembly | Connects Handpiece and the Head part |
| No. | Component | |
| Name | Function | |
| A. Components of Main Body of the Dental Handpiece Model CA160L | ||
| A1 | Spindle Assembly | Receives torque from Middle Gear Assembly and transmits torque to final dental bur |
| A2 | Middle Gear | |
| Assembly | Transmitting the rotational force from the Inner Handle Assembly and delivers the rotational force to the Spindle Assembly | |
| A3 | Button Assembly | Button for removal and attachment of the hand piece head |
| A4 | Head Cap | Case that wraps the Spindle Assembly. Head Cap is assembled with Button Assembly and Middle Gear Assembly |
| A5 | Head Assembly | The component that is assembled Spindle Assembly, Middle Gear Assembly, Button Assembly, Head Assembly |
| A6 | Gear Box | |
| Assembly | It consists of several gears and decelerates. | |
| A7 | Joint Gear | |
| Assembly | Transmits the torque received from the motor to the Head Assembly | |
| A8 | Inner Handle | Case to fix Joint Assembly |
| A9 | Locking Handle | Head assembly's attachment and detachment. |
| A10 | Angle Handle | |
| Assembly | The case of Joint Gear Assembly, Optic, Head | |
| B. Components only available for CA160L | ||
| B1 | Optic | Optical fiber that allows light to pass from the motor's LED light source to the handpiece head |
| B2 | Angle Body | The case is installed in Handle Assembly and protect the optics. |
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Table IV-3 Component Names and Functional Descriptions for Critical Components of Dental Handpiece model CA160L
V. INDICATIONS FOR USE/INTENDED USE
Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) is intended for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth
9
preparations, and restorations for polishing teeth. The Dental Handpiece is designed for use by a trained professional in the field of general dentistry.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Fundamental technological characteristics of Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) are substantially equivalent to the predicate devices, MICRO-NX Dental Handpiece model CA160L (K220577) and Saeyang Microtech Co., Ltd. Endo A Class (K123582) as demonstrated in Table VI-1 below.
| | Proposed Device:
Dental Handpiece,
Wireless
Endodontic
Handpiece, endoit
(model number:
EH-C500) | Predicate Device:
Dental Handpiece
model CA160L
(MICRO-NX,
K220577) | Predicate Device:
Endo A Class
(Saeyang
Microtech Co.,
Ltd., K123582) | Substantial
Equivalence
Assessments |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use
/ Indications
for Use | Dental Handpiece,
Wireless
Endodontic
Handpiece, endoit
(model number:
EH-C500) is
intended for the
removal of carious
material, reducing
of hard tooth
structure, cavity
and crown
preparations, root
canal preparations,
removal of fillings,
processing and
finishing tooth
preparations, and
restorations for
polishing teeth.
Dental Handpiece
is designed for use
by a trained
professional in the
field of general
dentistry. | Dental Handpiece
model CA160L is
intended for the
removal of carious
material, reducing
of hard tooth
structure, cavity
and crown
preparations, root
canal preparations,
removal of fillings,
processing and
finishing tooth
preparations, and
restorations for
polishing teeth.
Dental Handpiece
is designed for use
by a trained
professional in the
field of general
dentistry. | This application
area extends to
endodontic
procedures using a
root canal
instrument which is
intended by the
manufacturer for
use in the
mechanical and
rotary preparation
of root canals. | Intended use and
indications for use
are the same
between Dental
Handpiece,
Wireless
Endodontic
Handpiece, endoit
(model number:
EH-C500) and the
predicate device
Dental Handpiece
model CA160L for
the removal of
carious material,
reducing of hard
tooth structure,
cavity and crown
preparations, root
canal preparations,
removal of fillings,
processing and
finishing tooth
preparations, and
restorations for
polishing teeth.
Dental Handpiece
is designed for use
by a trained |
| | | | | field of general
dentistry. |
| Functional
Principle | Compared to the
predicate
(K220577) Dental
Handpiece model
CA160L that is
coupled to
handpiece
connectors to
receive energy, the
proposed Dental
Handpiece,
Wireless
Endodontic
Handpiece, endoit
(model number:
EH-C500) has a
built-in battery in
the main body that
generates torque
force to transmit
rotational force to
the contra angle for
the general dental
treatments. | Through the micro
motor connected to
the dental treatment
unit, the Dental
Handpiece model
CA160L contra
angle handpiece is
equipped with a
handpiece
connection that
receives the energy,
the cooling water
and air for
treatment and the
light for
illumination the
operating area. | The motor turned
by the power
converted into
DC2.4V by
controller delivers
its turning power to
the file through
spin to perform
punching, cutting
and
removing
functions. The
hand-piece can be
operated, stopped
and
set/adjusted on/in
its speed, torque
and turning
direction by
handling of the
controller. | Similar Functional
Principle
In order to address
the wireless
function of the
proposed device, an
additional predicate
device, Endo A
Class, is being
submitted. The
wireless function
does not raise
questions about the
safety or
effectiveness of the
proposed device
compared to the
predicate device. |
| Dimensions | Main Body
Width: 23mm
Length: 27mm
Height: 155mm
Contra Angle
(EH-A01)
Diameter: 17mm
Length: 71mm
Height: 30mm
Head Length:
8.1mm | Connection
Diameter: 20mm
Length: 95mm
Head Length:
14mm
Head Diameter:
9mm | Main Body
Width: 27mm
Length: 28mm
Height: 192mm | The head size,
height, and
diameter of Dental
Handpiece,
Wireless
Endodontic
Handpiece, endoit
(model number:
EH-C500) are
broadly in
alignment with the
dimensions of the
predicate |
| | Head Diameter:
10.7mm | | | (K220577) Dental
Handpiece model
CA160L. The
minor differences
in the identified
dimensions do not
raise different
questions in terms
of the safety or
effectiveness of the
proposed Dental
Handpiece,
Wireless
Endodontic
Handpiece, endoit
(model number:
EH-C500). |
| Direct
patient-
contacting
portions of
the device | All materials for
the Dental
Handpiece,
Wireless
Endodontic
Handpiece, endoit
(model number:
EH-C500) are
listed in the raw
material table
including chemical
composition of the
waterlines and the
patient-contacting
portions of the
device.
Biocompatible
according to ISO
10993-1
(Biological
evaluation of
medical devices -
Part 1: Evaluation
and testing within a
risk management
system - ISO
10993-1:2009) | All materials for
Dental Handpiece
models are listed in
the raw material
table including
chemical
composition of the
waterlines and the
patient-contacting
portions of the
device.
Biocompatible
according to ISO
10993-1
(Biological
evaluation of
medical devices -
Part 1: Evaluation
and testing within a
risk management
system - ISO
10993-1:2009) | Biocompatible
according to ISO
10993-1
(Biological
evaluation of
medical devices -
Part 1: Evaluation
and testing within a
risk management
system - ISO
10993-1:2009) | The proposed
Dental Handpiece,
Wireless
Endodontic
Handpiece, endoit
(model number:
EH-C500) is an
additional model to
the predicate
(K220577) Dental
Handpiece model
CA160L and has
identical in-direct
patient contacting
materials.
Therefore, the
predicate device
biocompatibility
test results per the
standard of ISO
10993-1 are
applicable to the
proposed Dental
Handpiece,
Wireless
Endodontic
Handpiece, endoit
(model number:
EH-C500). |
| Indirect
patient-
contacting
portions of
the device | All materials for
the Dental
Handpiece,
Wireless
Endodontic | All materials for
Dental Handpiece
model CA160L are
listed in the tables
above including | Biocompatible
according to ISO
10993-1
(Biological
evaluation of | The proposed
Dental Handpiece,
Wireless
Endodontic
Handpiece, endoit |
| (water / air lines) | | | | |
| Handpiece, endoit
(model number:
EH-C500) are
listed including
chemical
composition of the
waterlines and the
patient-contacting
portions of the
device.
Biocompatible
according to ISO
10993-1
(Biological
evaluation of
medical devices -
Part 1: Evaluation
and testing within a
risk management
system - ISO
10993-1:2009) | chemical
composition of the
waterlines and the
patient-contacting
portions of the
device.
Biocompatible
according to ISO
10993-1
(Biological
evaluation of
medical devices -
Part 1: Evaluation
and testing within a
risk management
system - ISO
10993-1:2009) | medical devices -
Part 1: Evaluation
and testing within a
risk management
system - ISO
10993-1:2009) | (model number:
EH-C500) is an
additional model to
the predicate
(K220577) Dental
Handpiece model
CA160L and has
identical in-direct
patient contacting
materials.
Therefore, the
predicate device
biocompatibility
test results per the
standard of ISO
10993-1 are
applicable to the
proposed Dental
Handpiece,
Wireless
Endodontic
Handpiece, endoit
(model number:
EH-C500). | |
| Charging
Method | Charging Cradle | External electric
motor | Charging Cradle
The charging
method of the
proposed Dental
Handpiece,
Wireless
Endodontic
Handpiece, endoit
(model number:
EH-C500) is a
charging cradle,
identical to the
predicate device
(K123582). | |
| Chuck
Design | Push Button Chuck | Push Button Chuck | Push Button Chuck
The chuck design
of the proposed
Dental Handpiece,
Wireless
Endodontic
Handpiece, endoit
(model number:
EH-C500) is push
button chuck,
identical to the
predicate device | |
| Motor Speed
Range
(RPM's) | 120 ~ 500 rpm | Up to 20,000 rpm | 140-500rpm | The motor speed range of the proposed Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) is within a lower range compared to the predicate (K220577) CA160L Dental Handpiece model. Since the maximum speed range of the predicate device encompasses the speed range of the proposed model, it does not have any significant impact on establishing substantial equivalence. |
| Conformance
Standards
(Handpieces
and Motors) | ISO 14457
(Dentistry -
Handpieces and
motors - ISO
14457:2012) | ISO 14457
(Dentistry -
Handpieces and
motors - ISO
14457:2012) | ISO 14457
(Dentistry -
Handpieces and
motors - ISO
14457:2012) | Compliant with the same standards for dentistry handpiece and motors. |
| Conformance
Standards
(Shanks) | ISO 1797 (2017)
"Dentistry - Shanks
for rotary and
oscillating
instruments" | ISO 1797 (2017)
"Dentistry - Shanks
for rotary and
oscillating
instruments" | ISO 1797 (2017)
"Dentistry - Shanks
for rotary and
oscillating
instruments" | Compliant with the same standards of dentistry shanks. |
| Sterilization | Sterilizable
according to ISO
17665-1
(Sterilization of
health care
products - Moist
heat - Part 1:
Requirements for
the development,
validation and
routine control of a
sterilization process
for medical devices
on the final | Sterilizable
according to ISO
17665-1
(Sterilization of
health care
products - Moist
heat - Part 1:
Requirements for
the development,
validation and
routine control of a
sterilization process
for medical devices
on the final | Sterilizable
according to ISO
17665-1
(Sterilization of
health care
products - Moist
heat - Part 1:
Requirements for
the development,
validation and
routine control of a
sterilization process
for medical devices
on the final | Conform to the same standards for user sterilization. |
| finished device -
ISO 176651:2006) | finished device -
ISO 176651:2006) | finished device -
ISO 176651:2006) | | |
| Gear Ratio | 1:1 | 16:1 | 4:1, 10:1, 16:1,
20:1 | Compared to the
predicate
(K220577) of
Dental Handpiece
model CA160L
gear ratio of 16:1,
the proposed
Dental Handpiece,
Wireless
Endodontic
Handpiece, endoit
(model number:
EH-C500) lower
gear ratio of 1:1
does not raise
different questions
in terms of the
safety or
effectiveness of the
proposed Dental
Handpiece,
Wireless
Endodontic
Handpiece, endoit
(model number:
EH C500) |
Table VI-1. Substantial Equivalence Assessment between Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) and Predicate Devices (K220577) and K(123582)
10
11
12
13
14
Overall, design verification testing were performed to assess the following critical elements of medical devices used in dentistry applications. The favorable test results of the proposed device which confirmed to meet the FDA recognized standards as well as ISO standard demonstrate that the proposed Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) retains the substantially equivalent profile in safety and essential performance of medical electrical equipment as the predicate (K220577) Dental Handpiece model CA160L and predicated (K123582) Endo A Class.
- ISO 14457 (2017) "Dentistry Handpieces and motors" (Recognition List Number: 031 . Effective Date: 09/15/2012)
- ISO 1797 (2017) "Dentistry - Shanks for rotary and oscillating instrument
The following IEC standard tests have been completed to evaluate electrical safety and performance of the Dental Handpiece. Wireless Endodontic Handpiece, endoit (model number: EH-C500):
- IEC 60601-1 (2005) "Medical electrical equipment Part 1: General requirements for basic ● safety and essential performance"
15
- IEC60601-1-2 (2014) "Edition 4.0 2014-02 Medical electrical equipment Part 1-2: ● General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests"
VII. DESIGN VERIFICATION & PERFORMANCE DATA
The following design verification and performance data are provided in support of the conclusive determination that the proposed dental handpiece is substantially equivalent to the predicate device Dental Handpiece model CA160L (MICRO-NX, K220577).
Biocompatibility Testing
The biocompatibility testing conducted for the predicate device Dental Handpiece model CA 160L(MICRO-NX, K220577) is applicable to the proposed Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500). The proposed Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) is an additional model to the predicate device Dental Handpiece model CA160L (MICRO-NX, K220577). All of the patientcontacting raw materials of the proposed Dental Handpiece. Wireless Endodontic Handpiece, endoit (model number: EH-C500) are the same as the predicate device Dental Handpiece (MICRO-NX, K220577) with no new introduction of patient contacting raw materials for the proposed Dental Handpiece model.
In accordance with ISO 10993-1: 2009. Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process, the Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) is categorized under "Externally Communicating Device-Tissue/bone/dentin (Limited contact duration). This is the same category of the biocompatibility evaluation as the predicate (K220577) Dental Handpiece model CA160L.
The biocompatibility testing has been conducted with the FDA-approved Dental Handpiece model SG200L (K192809) in 2019 in order to ensure FDA's latest consensus standards with respect to biological safety evaluations are met for the proposed device. The predicate (K220577) Dental Handpiece model CA160L was approved by the FDA on July 29th, 2022 and in this submission the Dental Handpiece including model SG200L was used as the predicate device (K192809) for substantial equivalence. The Dental Handpiece model CA160L (K220577) and Dental Handpiece including model SG200L (K192809) were assessed as substantially equivalent and the biocompatibility test results of the Dental Handpiece model SG200L was used as evidence for the Dental Handpiece CA160L (K220577).
- ISO MEM Elution Using L-929 Mouse Fibroblast Cells (GLP)
- ISO Guinea Pig Maximization Sensitization Test (GLP 2 Extracts) ●
- ISO Intracutaneous Irritation Test (GLP 2 Extracts) ●
- ISO Materials Mediated Rabbit Pyrogen (GLP) ●
- . ISO Acute Systemic Injection Test (GLP - 2 Extracts)
16
Design Verification and Validation Testing
The proposed, Micro-NX Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) has been evaluated and risk management practices have been implemented in accordance with ISO 14971:2019/A1:2021 Medical devices - applications of risk management to medical devices.
- Appearance Test ●
- Operation Test
- Rotational Speed Test ●
- . Noise Test
- Serviceable Year/ Shelf-Life Test ●
- IEC 60601-1
- IEC 60601-1-2 ●
The favorable results of the design verification testing demonstrate the design output of Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) conforms to the applicable, pre-determined design requirements of the Dental Handpiece. The testing results also further demonstrate the proposed Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) is substantially equivalent to the predicate (K220577) Dental Handpiece model CA160L, as the proposed and predicate device are subject to the same applicable test standards of design requirements for dental handpieces.
Therefore, the identified differences in terms of the dimensions and outer appearance between the proposed Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) and the predicate (K220577) Dental Handpiece model CA160L do not raise different questions regarding the safety or effectiveness of the proposed device.
VIII. CONCLUSIONS
Overall, the proposed device is assessed substantially equivalent to the predicate devices given the fact that its indications for use are the same, and fundamental technological characteristics are equivalent to those of the predicate device Dental Handpiece (MICRO-NX, K220577). The positive outcomes from the design verification and performance testing mentioned above confirm alignment with the relevant standards related to dental handpieces. Furthermore, they highlight that there are no additional concerns regarding safety and effectiveness assessment when compared to the predicate devices of Dental Handpiece model CA160L (MICRO-NX, K220577) or the Endo A Class (K123582).