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.

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

AI/ML Overview

I am sorry, but the provided document does not contain the detailed information needed to fully answer your request regarding acceptance criteria and study details for an AI/ML device.

The document is a 510(k) premarket notification for MDK Handpieces (dental handpieces), which are mechanical devices, not AI/ML software. Therefore, the "acceptance criteria" and "study" mentioned in this document refer to the performance of these mechanical dental handpieces against established standards for such devices, and not to the performance of an AI/ML algorithm.

Specifically, the document discusses:

Device Name: MDK Handpieces (high-speed and low-speed dental handpieces)
Regulation Number: 21 CFR 872.4200
Regulation Name: Dental Handpiece and Accessories
Product Code: EFB
Predicate Devices: Other legally marketed dental handpieces.
Performance Data: States that bench tests were performed and "passed the pre-set criteria." These tests include:
- Bur release force test
- Reverse analysis report for compatibility with third-party couplings
- Sterilization validation test (in accordance with ISO standards)
- Performance test (in accordance with ISO 14457)
- Biocompatibility test (in accordance with ISO 10993-5)
- Compatibility test for third-party couplings

Therefore, I cannot extract the following information which is specific to AI/ML device studies from this document:

A table of acceptance criteria and reported AI device performance.
Sample size used for the test set and data provenance.
Number of experts used to establish ground truth and their qualifications.
Adjudication method.
Whether an MRMC comparative effectiveness study was done for AI assistance.
Whether a standalone (algorithm only) performance study was done.
Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for AI/ML.
Sample size for the training set.
How the ground truth for the training set was established.

This document focuses on demonstrating substantial equivalence of a new medical device to existing predicate devices based on fundamental design, principles of operation, materials, performance specifications, and sterilization methods, primarily through physical and biocompatibility testing.

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)

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 PredicateDevice	Reference PredicateDevice
Device Name	MDK handpieces- High-speed handpieces	MASTERtorqueLUX 8900 L	Dental Air-PoweredHandpiece, modelsTIGER 300T, TIGER300K, TIGER 300W,TIGER 300B, TIGER300N
210K	K141886	K130560	K062812
Manufacturer	MODERN KOREA Co.,Ltd.	Kaltenbach & VoighGMPH	THUNDER TIGERCORP.
Indications foruse	MDK high-speedhandpieces are used forthe removal of cariousmaterial, reducing ofhard tooth structure,cavity and crownpreparations, removal offillings, processing andfinishing toothpreparations,restorations, and forpolishing teeth. All thedevices are designed foruse by a trainedprofessional in the fieldof general dentistry.	The MASTERtorqueLUX 8900 L is intendedfor the removal ofcarious material,reducing hard toothstructure, cavitypreparation, finishingtooth preparations,restorations, and forpolishing teeth. They aredesigned for use by atrained professional inthe field of generaldentistry.	THUNDER TIGERDental Air-PoweredHandpiece, modelsTIGER 300TTIGER300K, TIGER 300WTIGER 300B. TIGER300N are intended forremoving cariousmaterial, reducing hardtooth structure, cavitypreparation, finishingtooth preparations andrestorations andpolishing teeth.
Principleof operation	Through the tubesconnected to a dentalunit, the air-poweredhandpiece receives theair for rotation, thecooling water and lightfor illumination of theoperation area.	Through the tubesconnected to a dentalunit, the air-poweredhandpiece receives theair for rotation, thecooling water and lightfor illumination of theoperation area.	Through the tubesconnected to a dentalunit, the air-poweredhandpiece receives theair for rotation, thecooling water and lightfor illumination of theoperation area.
Air/water ports	Up to four	Up to four	Information notavailable
Fiber optics	With or without built-inlight system	With built-in lightsystem	With or without built-inlight system
Type of chuckChemical	Push button	Push button	Identical
composition ofthe patient-contactingportions of thedevice	Stainless steel andtitanium	Stainless steel	Titanium
Chemicalcomposition ofthe water/air	Stainless steel andtitanium	German silver andstainless steel	Information notavailable
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 byNSK(K052700)	KaVo QUATTROcare(K071288)	Liquid oil type spraycan
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-speedhandpieces	Vigor Series Low speed dentalhandpieces
510K	K141886	K112305
Manufacturer	MODERN KOREA Co., Ltd.	THUNDER TIGER CORP.
Indications for use	MDK low-speed handpieces usedfor teeth cutting, cavity and crownpreparation, restorations andpolishing teeth.All the devices are designed foruse by a trained professional in thefield of general dentistry.	The Vigor Series Low speed dentalhandpieces & Accessories arepowered by either low speed airmotor or electric micro-motor forteeth cutting, cavity and crownpreparation, restorations andpolishing teeth. The Vigor A LowSpeed Air Motor is used inconjunction with accessories such ascontra-angle, such as The Vigor CLow Speed Contra-Anglehandpieces, and straight handpiece,such as The Vigor S Low SpeedStraight handpieces. The motorcontains chip air and water that helpwith removing debris from teethcutting. The Low Speed ContraAngle Dental Handpiece that isintended for removing cariousmaterial, cavity and crownpreparations, finishing tooth
Principleof operation	Through the tubes connected to adental unit, the air-poweredhandpiece receives the air forrotation, the cooling water andlight for illumination of theoperation area.	Through the tubes connected to adental unit, the air-poweredhandpiece receives the air forrotation, the cooling water and lightfor illumination of the operationarea.preparations, reducing hard toothstructures, restorations and polishingteeth. The Straight Handpiececontains chip air and water that helpwith removing debris from teethcutting.
Air/water ports	Up to 4 holes	Up to 4 holes
Fiber optics	With or without built-in lightsystem	With or without built-in light system
Type of chuck	push button, latch, screw, snap-onor tip-lock chuck options	Push button & latch type
Chemicalcomposition of thepatient-contactingportions of thedevice	Stainless steel and titanium	Stainless steel
Chemicalcomposition of thewater/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 forthe latch type, Connectorfor inserting lubricant, ExternalSpray Tubing with nozzle	Head opener forthe latch type, Connectorfor inserting lubricant, ExternalSpray Tubing with nozzle
Lubricant	Pana-Spray made byNSK(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.

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.