Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description details a mechanical, air-powered dental handpiece with no mention of software, algorithms, or data processing capabilities that would indicate the use of AI or ML.

Therapeutic

No
The device is used for mechanical procedures like removing carious material and preparing teeth, and its function is to cut and polish, which is not considered treating a disease or condition therapeutically.

Diagnostic

No

This device is a dental handpiece used for various dental procedures such as removing carious material, reducing hard tooth structure, and preparing cavities. Its function is to perform physical alterations to teeth, not to diagnose conditions.

SaMD (Software as a Medical Device)

No

The device description clearly details physical, air-powered handpieces made of titanium and stainless steel, with features like fiber optic lights and chuck systems for burs. There is no mention of software as the primary or sole component.

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 for diagnosis, monitoring, or screening.
Device Function: The MDK handpieces are dental tools used directly on the patient's teeth for procedures like removing material, preparing cavities, and polishing. They are mechanical devices that perform physical actions on the tooth structure.
Intended Use: The intended use clearly describes procedures performed in vivo (on a living organism), not in vitro (in a lab setting with specimens).

The description and intended use of the MDK handpieces align with a dental device used for direct treatment, not an IVD used for analyzing biological samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

MDK high-speed handpieces are used for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, removal of fillings, processing and finishing tooth preparations, and for polishing teeth. MDK low-speed handpieces used for teeth cutting, cavity and crown preparations and polishing teeth. All the devices are designed for use by a trained professional in the field of general dentistry.

Product codes

EFB

Device Description

The MDK handpieces are dental hand pieces for use by a trained professional in the field of general dentistry. They are air-powered handpieces that are reusable and have a fiber optic light system (some models do not have this feature.). The MDK handpieces are supplied with water, air and light through the tube and dental treatment units.

The MDK handpieces offer high-speed handpieces and low-speed handpieces according to rpm. The high-speed handpieces with fiber optic have 11 models and those without fiber optic have 10 models. The low-speed handpieces are divided into 3 types: contra angle handpieces provided with and without a fiber optic light system, and straight handpieces. The contra angle handpieces with fiber optic have 4 models and those without fiber optic have 10 models. The straight handpieces have 2 models.

The MDK handpieces are hand-held, channeled instruments that are powered by compressed air delivered through a hose to an air channel in the handpieces. This impels the turbine in the head of the handpiece to revolve. The bur of the high speed handpieces can rotate up to 400,000 rpm and the bur of the low speed handpieces can rotate up to 100,000 rpm. Dental burs (not part of this 510k) can be inserted into the chuck system of each handpiece (push button, latch, screw, snap-on or tip-lock chuck options).

The low-speed handpieces are used with the air motors (20.000 rpm) made by our company and offer various gear ratio (1:1(constant), 20:1(speed reduction), 30:1(speed reduction), and 1:5(speed increase)). The high-speed handpieces are used with the following compatible couplings made by the third party manufacturers.

Kaltenbach & Voigt GmbH & Co. : KaVo MULTIflex LUX Series
Sirona Dental Systems GmbH : Sirona R/F Series
W&H Dentalwerk Bumoos GmbH : W&H Series
Bien-Air Dental S.A. : BienAir Unifix L Series
NSK : NSK Machlite/Phatelus Series

The headpieces are made of titanium and stainless steel, and must be cleaned and sterilized between use by the user.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Tooth/teeth, hard tooth structure

Indicated Patient Age Range

Not Found

Intended User / Care Setting

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

The following bench tests have been performed on the subject device and passed the pre-set criteria:

Bur release force test
Reverse analysis report for compatibility with the third party couplings
Sterilization validation test in accordance with ISO 17665, ISO 11138, ISO 11135, ISO 11607, ISO 17664, and USP 30-NF 25
Performance test in accordance with ISO 14457
Biocompatibility test in accordance with ISO 10993-5
Compatibility test for the third party couplings

The subject device also conformed to the FDA guidance document for Dental Handpieces.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K130560, K112305

Reference Device(s)

K062812

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads in profile, facing right. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.

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

May 13, 2015

Modern Korea Co. Ltd. c/o Ms. Priscilla Chung LK Consulting Group USA, Inc. 2651 East Chapman Avenue, Suite 110 Fullerton California, 92831

Re: K141886

Trade/Device Name: MDK Handpieces Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: April 13, 2015 Received: April 14, 2015

Dear Ms. Chung:

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.

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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 (reporting of medical device-related 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 yours,

Tina
Kiang -S

for Erin I. Keith, M.S. 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) K141886

Device Name

MDK Handpieces

Indications for Use (Describe)

MDK high-speed handpieces are used for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, removal of fillings, processing and finishing tooth preparations, and for polishing teeth. MDK low-speed handpieces used for teeth cutting, cavity and crown preparations and polishing teeth. All the devices are 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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510(k) Summary (K141886)

This summary of 510(K) is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: 05/11/2015

1. 510k Applicant / Submitter

Modern Korea Co., Ltd. #604, Ilsantechnotown, 138, Ilsan-ro, Ilsandong-gu, Goyang-si, Gyeonggi-do, 410-722, Republic of Korea Tel: +82-31-906-5601 Fax: +82-31-906-5600

2. Submission Correspondent

Priscilla Chung LK Consulting Group USA, Inc. 2651 E Chapman Ave. Ste 110, Fullerton, CA 92831 Phone: 714-202-5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com

3. Device

· Trade Name: MDK Handpieces
Classification Name: Dental Handpiece and Accessories .
· Classification Regulation: Class I, 21 CFR 872.4200
· Product Code: EFB

4. Predicate Device:

· Primary Predicate Device for MDK High-Speed Handpieces: MASTERtorque LUX 8900 L (K130560) by Kaltenbach & Voigh GMbH
· Reference Predicate Devices for MDK High-Speed Handpieces: Dental Air-Powered Handpiece, models TIGER 300TTIGER 300K, TIGER 300W, TIGER 300B (K062812) by THUNDER TIGER CORP.
· Primary Predicate Device for MDK Low-Speed Handpieces: Vigor Series Low speed dental handpieces (K112305) by THUNDER TIGER CORP.

5. Description:

The MDK handpieces are dental hand pieces for use by a trained professional in the field of general

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dentistry. They are air-powered handpieces that are reusable and have a fiber optic light system (some models do not have this feature.). The MDK handpieces are supplied with water, air and light through the tube and dental treatment units.

The MDK handpieces offer high-speed handpieces and low-speed handpieces according to rpm. The high-speed handpieces with fiber optic have 11 models and those without fiber optic have 10 models. The low-speed handpieces are divided into 3 types: contra angle handpieces provided with and without a fiber optic light system, and straight handpieces. The contra angle handpieces with fiber optic have 4 models and those without fiber optic have 10 models. The straight handpieces have 2 models.

The MDK handpieces are hand-held, channeled instruments that are powered by compressed air delivered through a hose to an air channel in the handpieces. This impels the turbine in the head of the handpiece to revolve. The bur of the high speed handpieces can rotate up to 400,000 rpm and the bur of the low speed handpieces can rotate up to 100,000 rpm. Dental burs (not part of this 510k) can be inserted into the chuck system of each handpiece (push button, latch, screw, snap-on or tip-lock chuck options).

The low-speed handpieces are used with the air motors (20.000 rpm) made by our company and offer various gear ratio (1:1(constant), 20:1(speed reduction), 30:1(speed reduction), and 1:5(speed increase)). The high-speed handpieces are used with the following compatible couplings made by the third party manufacturers. *

1. Kaltenbach & Voigt GmbH & Co. : KaVo MULTIflex LUX Series
1. Sirona Dental Systems GmbH : Sirona R/F Series
1. W&H Dentalwerk Bumoos GmbH : W&H Series
1. Bien-Air Dental S.A. : BienAir Unifix L Series
1. NSK : NSK Machlite/Phatelus Series

The headpieces are made of titanium and stainless steel, and must be cleaned and sterilized between use by the user.

6. Indications for Use:

MDK high-speed handpieces are used for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, removal of fillings, processing and finishing tooth preparations, restorations, and for polishing teeth. MDK low-speed handpieces used for teeth cutting, cavity and crown preparation, restorations and polishing teeth.

All the devices are designed for use by a trained professional in the field of general dentistry.

7. Comparison to the Cleared Device

7.1. High-speed handpieces

The subject device is intended for the same use as MASTERtorque LUX 8900 L by Kaltenbach & Voigh GmbH and the Dental Air-Powered Handpiece, models TIGER 300T. TIGER 300K, TIGER300W, TIGER 300B, and TIGER 300N by THUNDER TIGER CORP. The subject device is substantially equivalent to the predicate devices in design, principle of operation, raw materials, performance specifications and sterilization method. The internal structure or design, and the materials of the subject device might be different from the predicate devices; however, the test results of the biocompatibility test, the sterilization validation, and the performance tests support that the subject device is

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substantially equivalent to the predicate devices.

| | Subject Device | Primary Predicate
Device | Reference Predicate
Device |
|---------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | MDK handpieces

High-speed handpieces | MASTERtorque
LUX 8900 L | Dental Air-Powered
Handpiece, models
TIGER 300T, TIGER
300K, TIGER 300W,
TIGER 300B, TIGER
300N |
| 210K | K141886 | K130560 | K062812 |
| Manufacturer | MODERN KOREA Co.,
Ltd. | Kaltenbach & Voigh
GMPH | THUNDER TIGER
CORP. |
| Indications for
use | MDK high-speed
handpieces are used for
the removal of carious
material, reducing of
hard tooth structure,
cavity and crown
preparations, removal of
fillings, processing and
finishing tooth
preparations,
restorations, and for
polishing teeth. All the
devices are designed for
use by a trained
professional in the field
of general dentistry. | The MASTERtorque
LUX 8900 L is intended
for the removal of
carious material,
reducing hard tooth
structure, cavity
preparation, finishing
tooth preparations,
restorations, and for
polishing teeth. They are
designed for use by a
trained professional in
the field of general
dentistry. | THUNDER TIGER
Dental Air-Powered
Handpiece, models
TIGER 300TTIGER
300K, TIGER 300W
TIGER 300B. TIGER
300N are intended for
removing carious
material, reducing hard
tooth structure, cavity
preparation, finishing
tooth preparations and
restorations and
polishing teeth. |
| Principle
of operation | Through the tubes
connected to a dental
unit, the air-powered
handpiece receives the
air for rotation, the
cooling water and light
for illumination of the
operation area. | Through the tubes
connected to a dental
unit, the air-powered
handpiece receives the
air for rotation, the
cooling water and light
for illumination of the
operation area. | Through the tubes
connected to a dental
unit, the air-powered
handpiece receives the
air for rotation, the
cooling water and light
for illumination of the
operation area. |
| Air/water ports | Up to four | Up to four | Information not
available |
| Fiber optics | With or without built-in
light system | With built-in light
system | With or without built-in
light system |
| Type of chuck
Chemical | Push button | Push button | Identical |
| composition of
the patient-
contacting
portions of the
device | Stainless steel and
titanium | Stainless steel | Titanium |
| Chemical
composition of
the water/air | Stainless steel and
titanium | German silver and
stainless steel | Information not
available |
| lines | | | |
| Bur retention force | 30N | Up to 24N | 35N |
| Operating pressure | 36psi to 43psi | 41 psi recommended | Information not available |
| Rotation Speed | 320,000 ~ 400,000rpm | 340,000 ~ 400,000rpm | 300,000 ~ 350,000 rpm |
| Accessories | Wrench, Connector
(for inserting lubricant) | Wrench, Connector
(for inserting lubricant) | Wrench, Connector
(for inserting lubricant) |
| Lubricant | Pana-Spray made by
NSK(K052700) | KaVo QUATTROcare
(K071288) | Liquid oil type spray
can |
| Sterilization | Steam autoclave method | Steam autoclave method | Steam autoclave method |

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7.2. Low-speed handpieces

The subject device is intended for the same use as Vigor Series Low speed dental handpieces by THUNDER TIGER CORP. The subject device is substantially equivalent to the predicate device in design, principle of operation, raw materials, performance specifications and sterilization method.

The subject device offers more chuck system models than the predicate device, but the test results of the bur release force test supported that this difference would not raise a question of the risk related to chuck.

	Subject Device	Primary Predicate Device
Device Name	MDK handpieces - Low-speed
handpieces	Vigor Series Low speed dental
handpieces
510K	K141886	K112305
Manufacturer	MODERN KOREA Co., Ltd.	THUNDER TIGER CORP.
Indications for use	MDK low-speed handpieces used
for teeth cutting, cavity and crown
preparation, restorations and
polishing teeth.
All the devices are designed for
use by a trained professional in the
field of general dentistry.	The Vigor Series Low speed dental
handpieces & Accessories are
powered by either low speed air
motor or electric micro-motor for
teeth cutting, cavity and crown
preparation, restorations and
polishing teeth. The Vigor A Low
Speed Air Motor is used in
conjunction with accessories such as
contra-angle, such as The Vigor C
Low Speed Contra-Angle
handpieces, and straight handpiece,
such as The Vigor S Low Speed
Straight handpieces. The motor
contains chip air and water that help
with removing debris from teeth
cutting. The Low Speed Contra
Angle Dental Handpiece that is
intended for removing carious
material, cavity and crown
preparations, finishing tooth
Principle
of operation	Through the tubes connected to a
dental unit, the air-powered
handpiece receives the air for
rotation, the cooling water and
light for illumination of the
operation area.	Through the tubes connected to a
dental unit, the air-powered
handpiece receives the air for
rotation, the cooling water and light
for illumination of the operation
area.
preparations, reducing hard tooth
structures, restorations and polishing
teeth. The Straight Handpiece
contains chip air and water that help
with removing debris from teeth
cutting.
Air/water ports	Up to 4 holes	Up to 4 holes
Fiber optics	With or without built-in light
system	With or without built-in light system
Type of chuck	push button, latch, screw, snap-on
or tip-lock chuck options	Push button & latch type
Chemical
composition of the
patient-contacting
portions of the
device	Stainless steel and titanium	Stainless steel
Chemical
composition of the
water/air lines	Stainless steel	Stainless steel
Bur retention force	30N	Information not available
Operating pressure	36psi to 43psi	Information not available
Speed (Motor)	Up to 20,000 rpm	Up to 25,000 rpm
Accessories	Head opener for
the latch type, Connector
for inserting lubricant, External
Spray Tubing with nozzle	Head opener for
the latch type, Connector
for inserting lubricant, External
Spray Tubing with nozzle
Lubricant	Pana-Spray made by
NSK(K052700)	Information not available
Sterilization	Steam autoclave method	Steam autoclave method

510(k) summary , 4 / 6 page

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8. Performance Data

The following bench tests have been performed on the subject device and passed the pre-set criteria.

Bur release force test ●
Reverse analysis report for compatibility with the third party couplings .
. Sterilization validation test in accordance with ISO 17665, ISO 11138, ISO 11135, ISO 11607, ISO 17664, and USP 30-NF 25
Performance test in accordance with ISO 14457 ●
Biocompatibility test in accordance with ISO 10993-5 ●

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Compatibility test for the third party couplings
The subject device also conformed to the FDA guidance document for Dental Handpieces.

9. Conclusion

Based on the information provided in this 510k submission, we have concluded that our devices are substantially equivalent to the predicate device.