The MASTERmatic LUX handpieces are 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. They are designed for use by a trained professional in the field of general dentistry.

Device Description

The MASTERmatic LUX electrical-driven handpieces - MASTERmatic LUX M25 L, MASTERmatic LUX M20 L, MASTERmatic LUX M10 L, MASTERmatic LUX M07 L, MASTERmatic LUX M29 L, MASTERmatic LUX M05 L are dental handpieces for the use by a trained professional in the field of general dentistry. The devices are electrical-powered handpieces that are reusable and ergonomically shaped, and provided with a fiber optic light system. The devices can be sterilized by the steam autoclave method. Through the tube and the electrical motor connected to a dental unit, the MASTERmatic LUX handpieces equipped with a handpiece connection according to ISO 3964 (Dentistry - Coupling dimensions for handpiece connectors - ISO 3964:1982) receive the energy for the gear, the cooling water and air for cutting treatment through pouring holes and light for illumination the operation area. Dental burs and other attachments according to ISO 1797-1 (Dentistry - Shanks for rotary instruments - Part 1: Shanks made of metals - ISO 1797-1:2011) will be used with the MASTERmatic LUX handpieces.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from referenced standards)	Reported Device Performance (MASTERmatic LUX)
Intended Use/Indications for Use: Removal of carious material, reducing hard tooth structure, cavity & crown preparations, root canal preparations, removal of fillings, processing & finishing tooth preparations/restorations, polishing teeth. Designed for use by a trained dental professional.	Same as acceptance criteria (stated in "Statement of Intended Use" and "Summary of the Technological Characteristics").
Functional Principle: Receives energy, cooling water, air for treatment, and light for illumination via micro motor connected to dental unit, complying with ISO 3964.	Same as acceptance criteria (stated in "Summary of the Technological Characteristics" and "Mechanism of Action").
Air/Water ports: Internal Spray	Internal Spray (stated in "Summary of the Technological Characteristics")
Fiberoptics: Must have a light system.	With built-in light system (stated in "Summary of the Technological Characteristics")
Speed Range: Up to 200,000 rpm	Up to 200,000 rpm (stated in "Summary of the Technological Characteristics")
Rotary Instruments: Compatible with burs, cutters, and other attachments (straight or contra-angle shank) according to ISO 1797-1.	Compatible with burs, cutters, and other attachments (straight or contra-angle shank) according to ISO 1797-1 (stated in "Summary of the Technological Characteristics").
Biocompatibility: Direct and indirect patient-contacting portions must be biocompatible according to ISO 10993-1.	Complies with ISO 10993-1 (stated in "Summary of the Technological Characteristics").
Light Intensity: Approx. 25,000 LUX	Approx. 25,000 LUX (stated in "Summary of the Technological Characteristics").
Bur retention force: Min. 22 N (45 N for straight handpieces)	Min. 22 N (45 N straight handpieces) (stated in "Summary of the Technological Characteristics").
Sterilization: Sterilizable according to ISO 17665-1 (Moist heat).	Sterilizable according to ISO 17665-1 (stated in "Summary of the Technological Characteristics").
Compliance to Standards: ISO 14457 (Dentistry - Handpieces and motors), ISO 1797-1 (Dentistry - Shanks for rotary instruments), ISO 3964 (Dentistry - Coupling dimensions for handpiece connectors).	Complies with ISO 14457, ISO 1797-1, ISO 3964 (stated in "Summary of the Technological Characteristics" and "Non-Clinical Test Data").

2. Sample size used for the test set and the data provenance

The document explicitly states: "Non-Clinical Test Data". This indicates that the testing was bench testing and not performed on human subjects. Therefore, there is no "test set" in the context of patient data, nor is there any provenance related to country of origin for such data. The testing was conducted according to international standards for dental gear-driven handpieces.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This section is not applicable. The device underwent "Non-Clinical Test Data" (bench testing) and "Clinical testing has not been conducted on this product." Therefore, there was no human expert adjudication for a clinical ground truth.

4. Adjudication method for the test set

This section is not applicable. As no clinical studies were performed that required expert adjudication, no adjudication method was used.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This section is not applicable. No MRMC study was conducted, as no clinical studies were performed and the device is a dental handpiece, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This section is not applicable. The device is a dental handpiece and does not involve an algorithm or AI. Performance was assessed through non-clinical bench testing.

7. The type of ground truth used

The ground truth used for performance verification was based on compliance with established international standards for dental devices (bench testing outcomes). This includes:

ISO 3964 (Dentistry - Coupling dimensions for handpiece connectors)
ISO 1797-1 (Dentistry - Shanks for rotary instruments)
ISO 10993-1 (Biological evaluation of medical devices - Biocompatibility)
ISO 14457 (Dentistry - Handpieces and motors)
ISO 17665-1 (Sterilization of health care products - Moist heat)

8. The sample size for the training set

This section is not applicable. There is no mention of a training set as this is a physical medical device, not a machine learning model.

9. How the ground truth for the training set was established

This section is not applicable. There is no training set mentioned or implied in the provided document.

Summary

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

April 9, 2015

Kaltenbach & Voigt Gmbh Mr. Stefan Trampler Director, Regulatory Affairs Bismarckring 39 Biberach, 88400 GERMANY

Re: K143465

Trade/Device Name: MASTERmatic LUX Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: Class I Product Code: EFA Dated: March 9, 2015 Received: March 13, 2015

Dear Mr. Trampler:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See RA Statement beloW.

510(k) Number K143465

Device Name MASTERmatic LUX

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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KaVo. Dental Excel

K143465

Section V - 510(k) Summary

Submitter:

Kaltenbach & Voigt GmbH Bismarckring 39 88400 Biberach Stefan Trampler - Contact Person 49 (7351) 56 3515 - Phone number +49 (7351) 56 7 3515 - Facsimile

Date Summary Prepared: March 09, 2015

Device Name:

Trade Name - MASTERmatic LUX
. Common Name - Handpiece, contra- and right-angle attachment, dental
. Classification Name - Dental handpiece and accessories, per 21 CFR & 872.4200
Device Class - Class I
Product Code - EGS

Devices for Which Substantial Equivalence is Claimed:

. A-dec 1 W&H Synea Air-Driven Highspeed Handpieces, Models TA-98, TA-97 1 A-dec 1 W&H Synea Handpiece Attachment, Models WA-99LT, WA-86LT, WA-66LT, WA-56LT, HA-43LT (K070663) marketed by W & H DENTALWERK BUERMOOS GMBH.

Device Description:

The MASTERmatic LUX electrical-driven handpieces

. MASTERmatic LUX M25 L
MASTERmatic LUX M20 L .
MASTERmatic LUX M10 L •
MASTERmatic LUX M07 L
. MASTERmatic LUX M29 L
. MASTERmatic LUX M05 L

are dental handpieces for the use by a trained professional in the field of general dentistry. The devices are electrical-powered handpieces that are reusable and ergonomically shaped, and provided with a fiber optic light system. The devices can be sterilized by the steam autoclave method. Through the tube and the electrical motor connected to a dental unit, the MASTERmatic LUX handpieces equipped with a handpiece connection according to ISO 3964 (Dentistry - Coupling dimensions for handpiece connectors - ISO 3964:1982) receive the energy for the gear, the cooling water and air for cutting treatment through pouring holes and light for illumination the operation area. Dental burs and other attachments according to ISO 1797-1 (Dentistry - Shanks for rotary instruments - Part 1: Shanks made of metals - ISO 1797-1:2011) will be used with the MASTERmatic LUX handpieces.

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The different electrical motors (i.e. INTRAmatic LUX KL 702) utilized with the MASTERmatic LUX handpieces, are registered with the different dental treatment units (K103027 in the case of INTRAmatic LUX KL 702). Based on the INTRAmatic connection that meets the ISO 3964 (Dentistry - Coupling dimensions for handpiece connectors - ISO 3964:1982) standard the MASTERmatic LUX handpieces fit with any electrical dental motor which is produced in accordance to this standard. The different electrical motors will not be delivered together with the MASTERmatic LUX handpieces. The electrical motors carry for the gear, the cooling water and air for cutting treatment and light for illumination from the dental treatment unit to the MASTERmatic LUX handpieces.

Accessories:

Additionally most models of the MASTERmatic LUX handpieces will be supplied with an exchange filter to filter the spray water in the water lines inside of the dental electrical-driven handpiece. For the assembly and dismantling of the exchange filter, a supporting tool is also included.

Furthermore there is a jet needle supplied with the MASTERmatic LUX handpieces. By using this part the operator is able to clean the spray holes in the head of the product.

The straight handpiece MASTERmatic LUX M10 L is equipped with a drill bit stop and a hook for removal of the drill.

Dental burs and other attachments that meets the ISO 1797-1 (Dentistry - Shanks for rotary instruments - Part 1: Shanks made of metals - ISO 1797-1:2011) standard may be inserted into the chuck system of the MASTERmatic LUX handpieces for applicable cutting operations based on the intended use.

Mechanism of Action:

The MASTERmatic LUX dental handpieces are electrical-driven handpieces which will be supplied with energy, water, air and light through the tube and the electrical motor of a dental treatment unit. Based on the speed adjusted in the dental treatment unit the handpiece bur rotates up to 200,000 rpm. The MASTERmatic LUX handpieces interact with the patient through a rotating bur with the patient teeth according to the intended use.

Statement of Intended Use:

The MASTERmatic LUX handpieces are 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 for polishing teeth. They are designed for use by a trained professional in the field of general dentistry.

Substantial Equivalence:

The MASTERmatic LUX handpieces function in a manner similar to and are intended for the same use as the A-dec 1 W&H Synea Air-Driven Highspeed Handpieces (K070663) marketed by W & H DENTALWERK BUERMOOS GMBH. The MASTERmatic LUX handpieces are similar to the predicate device (K070633) in that they are dental electrical-driven handpieces for the use by a trained professional in the field of general dentistry. The MASTERmatic LUX handpieces are substantially equivalent in design, application and function to the predicate device (K070663). Both the A-dec 1 W&H Synea Air-Driven Highspeed Handpieces (K070663) and the

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MASTERmatic LUX handpieces are reusable and ergonomically shaped. The devices can be sterilized by the steam autoclave method and they are both provided with a fiber optic light system. Dental burs and cutters (with straight handpiece shank or with contra-angle shank) according to ISO 1797-1 (Dentistry - Shanks for rotary instruments - Part 1: Shanks made of metals - ISO 1797-1:2011) can be used for both, the MASTERmatic LUX handpieces and the A-dec 1 W&H Synea Air-Driven Highspeed Handpieces (K070663). In addition both handpiece types, the MASTERmatic LUX handpieces and the A-dec 1 W&H Synea Air-Driven Highspeed Handpieces (K070663) are equipped with a handpiece connection according to ISO 3964 (Dentistry - Coupling dimensions for handpiece connectors - ISO 3964:1982) and receive the energy for the gear, the cooling water and air for cutting treatment through the tube and the specific electrical motor connected to a dental unit as the mechanism of action.

The MASTERmatic LUX handpieces differ from the A-dec 1 W&H Synea Air-Driven Highspeed Handpieces (K070663) in dimensions, fiber optic and lubrication. The MASTERmatic LUX handpieces are only available with a fiber optic light system for illumination of the operation area. Both devices use their own lubrication and have small differences in the dimensions (see Table - Summary of the Technological Characteristics).

The differences do not render the device NSE because the performance tests demonstrate that the differences in technological characteristics do not raise different questions of safety and effectiveness than the predicate and show that the device is equivalent to the predicate.

Summary of the Technological Characteristics:

Descriptive Information	MASTERmatic LUX	A-dec I W&H Synea Air-Driven HighspeedHandpiece, Models TA-98, TA-97 I A-dec IW&H Synea Handpiece Attachment, ModelsWA-99LT, WA-86LT, WA-66LT, WA-56LT,HA-43LT(K070663)(W & H DENTALWERK BUERMOOS GMBH)
Intended Use 1 Indicationsfor Use	LUXTheMASTERmatichandpiecesareintended for the removal of carious material,reducing of hard tooth structure, cavity andcrown preparations, root canal preparations,removal of fillings,processing and finishingpreparations,restorations,andtoothforpolishing teeth. They are designed for use bya trained professional in the field of generaldentistry.	The A-dec1W&H Synea Handpiece Attachment ispowered by either an air-motor or electricmicromotor for use in general dentistry. Thisdevice is designed for removing carious materialand excess filling material, cavity and crownpreparation, root canal preparations,finishingtooth preparations, restorations andpolishingteeth.
Functional Principle	Through the micro motor connected to thedental treatment unit the straight and contra-angle handpieces equipped with a handpiececonnection according to ISO 3964 (DentistryCoupling dimensions for handpiece connectors- ISO 3964:1982) receives the energy, thecooling water and air for treatment and thelight for illumination the operating area.	Throughthe micro motor connectedto thedental treatment unit the straight and contra-angle handpieces equipped with a handpiececonnection according to ISO 3964 (DentistryCoupling dimensions for handpiece connectorsISO 3964:1982) receives the energy, the coolingwater and air for treatment and the light forillumination the operating area.
Air 1 water ports	Internal Spray	Internal Spray
Fiberoptics	With built-in light system	With and without built-in light system
Dimensions	Headsize-Height: Up to 13,6 mmHeadsize-Diameter: Up to 10,2 mmLength: Up to 95,9 mm	Headsize-Height (with bur): Up to 20,8 mmHeadsize-Diameter: Up to 9,5 mmLength: Unknown
Type of chuck	Push Button, Twist-tension Chuck	Push Button, Twist-tension Chuck

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Rotary Instruments	For Burs, Cutters and other attachments (with straight handpiece shank or with contra-angle shank) according to ISO 1797-1 (Dentistry - Shanks for rotary instruments - Part 1: Shanks made of metals - ISO 1797-1:2011).	For Burs, Cutters and other attachments (with straight handpiece shank or with contra-angle shank) according to ISO 1797-1 (Dentistry - Shanks for rotary instruments - Part 1: Shanks made of metals - ISO 1797-1:2011).
Speed Range	Up to 200,000 rpm	Up to 200,000 rpm
Direct patient-contactingportions of the device	Biocompatible according to ISO 10993-1(Biological evaluation of medical devices - Part 1: Evaluation and testing within a riskmanagement system - ISO 10993-1:2009)	Unknown
Indirect patient-contactingportions of the device(water 1 air lines)	Biocompatible according to ISO 10993-1(Biological evaluation of medical devices - Part 1: Evaluation and testing within a riskmanagement system - ISO 10993-1:2009)	Unknown
Light Intensity	Approx. 25,000 LUX	Approx. 25,000 LUX
Bur retention force	Min. 22 N (45 N straight handpieces)	Unknown
	Complies with:ISO 14457 (Dentistry - Handpieces andmotors - ISO 14457:2012)	Complies with:ISO 14457 (Dentistry - Handpieces and motors -ISO 14457:2012)
Compliance to Standards	ISO 1797-1 (Dentistry - Shanks for rotaryinstruments - Part 1: Shanks made of metals -ISO 1797-1:2011)	ISO 1797-1 (Dentistry - Shanks for rotaryinstruments - Part 1: Shanks made of metals -ISO 1797-1:2011)
	ISO 3964 (Dentistry - Coupling dimensions forhandpiece connectors - ISO 3964:1982)	ISO 3964 (Dentistry - Coupling dimensions forhandpiece connectors - ISO 3964:1982)
Lubricant	KaVo QUATTROcare (K071288)	Unknown (Own Lubricant from W&H)
Sterilization	Sterilizable according to ISO 17665-1(Sterilization of health care products - Moist heat - Part 1: Requirements for thedevelopment, validation and routine control of a sterilization process for medical devices on the final, finished device - ISO 17665-1:2006)	Sterilizable according to ISO 17665-1(Sterilization of health care products - Moist heat - Part 1: Requirements for thedevelopment, validation and routine control of a sterilization process for medical devices on the final, finished device - ISO 17665-1:2006)

Non-Clinical Test Data:

Performance bench testing according to the international standards for dental gear-driven handpieces have been conducted to determine the conformance to the state of the art. Biocompatibility and sterilization studies have been completed which demonstrate that the MASTERmatic LUX handpieces are well-suited for their intended use.

The performance of the MASTERmatic LUX handpieces has been verified utilizing the following standards:

-ISO 3964 - 1982-12-00 - Dentistry - Coupling dimensions for handpiece connectors
-ISO 1797-1 - 2011-08-00 - Dentistry - Shanks for rotary instruments - Part 1: Shanks made of metals
-ISO 10993-1 - 2009-10-00 - Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management system
-ISO 14457 - 2012-09-15 - Dentistry - Handpieces and motors
-ISO 17665-1 - 2006-08-15 - 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, finished device

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Clinical Test Data:

Clinical testing has not been conducted on this product.

Conclusion:

Based upon the tests according to the international standards for dental gear-driven handpieces, the biocompatibility and sterilization studies and the similar technological 1 performance characteristics as compared to the predicate device, the performance of the MASTERmatic LUX handpieces is deemed to be 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.