EXPERTsurg: This KaVo product is intended for surgery to expose and dissect oral tissue structures or endodontic treatments (e.g. periodontal gap, gingiva, bone, jaw, extractions and implantations).
INTRA LUX S600 LED: The medical device is intended to drive / operate a dental handpiece / contra-angle handpiece equipped with a handpiece connection according to ISO 3964. This medical device is an electrical low-voltage motor for dental purposes according to ISO 11498 type 2 and classified as a type B application part.
SURGmatic S201 L / C; SURGmatic S201 XL / XC; SURGmatic S11 L / C: The medical device is intended for the following uses: Surgery such as setting an implant, bone augmentation, sinus lift, tooth extraction procedures, implantology, osteotomia, root resection and oral, jaw and facial surgery.

Device Description

The MASTERsurg / EXPERTsurg is a dental surgical system out of:

EXPERTsurg (surgical control unit)
INTRA LUX S600 LED (surgical motor)
SURGmatic S201 L / C (handpieces)
SURGmatic S201 XL / XC (handpieces)
SURGmatic S11 L / C (handpieces)
The MASTERsurg / EXPERTsurg is a system out of a surgical control unit (EXPERTsurg), a surgical motor (INTRA LUX S600 LED) and different handpieces (SURGmatic).
The surgical control unit (EXPERTsurg) consists of a surgical controller, a motor cable, an instruments tray, a holder and a tube set. The surgical motor (INTRA LUX S600 LED) consists of the motor, a stopper for maintenance purposes and exchange O-rings for the motor coupling.
As a functional principle the software-based surgical controls the speed and torque of a dental micro motor. The unit is equipped with a pump for the use with external irrigation tubing allowing irrigation of the working area. The surgical control unit is operated through the buttons on the tabletop console or via foot control. The surgical control unit is intended to be used with the INTRA LUX S600 LED motor. Straight or contra-angle handpieces with a handpiece connection according to ISO 3964 can be equipped. The instrument tray allows the dentist to deposit the SURGmatic handpieces in a safe position. The holder is intended to be used for general storage. The tube set is needed to deliver the external irrigation from the bottle (not part of this 510(k)) to the SURGmatic handpieces. A power cord provides electric power to the unit. The EXPERTsurg will be delivered with software on the surgical control unit. The EXPERTsurg follows the international standards for electrical safety and electromagnetic compatibility which are applicable for the use with human beings.
Each of the different handpieces (SURGmatic) consists of the handpiece, a spray clip (only SURGmatic S201 L / C and SURGmatic S201 XL / XC), a jet needle for cleaning purposes and a tube for the external spray.
The SURGmatic handpieces are electrical driven 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 (L version). The devices can be sterilized by the steam autoclave method. Through the INTRA LUX S600 LED motor connected to the surgical control unit, the SURGmatic handpieces equipped with a handpiece connection according to ISO 3964 receives the energy, the cooling water and air for treatment and the light for illumination the operation area (L version). Surgical burs and cutters (with straight handpiece shank or with contra-angle shank) according to ISO 1797 can be used with the SURGmatic handpieces. The SURGmatic handpieces use external spray allowing external irrigation to the working area. The mechanism of action for the SURGmatic handpieces is as follows. The dental straight and contra-angle handpieces are electrical-driven handpieces which will be supplied with energy, air and light through the dental micro motor of the surgical control unit. Dental burs (not part of this 510(k)) according to ISO 1797 could be inserted into the chuck system of the handpieces. Based on the speed adjusted in the surgical control unit the handpiece bur rotates up to 40,000 rpm. The SURGmatic handpieces interacts with the patient through a rotating bur with the patient teeth according to the intended use.

AI/ML Overview

The provided document is a 510(k) premarket notification for a dental surgical system. It focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance metrics against acceptance criteria in the context of a new, quantifiable medical AI device evaluation. Therefore, much of the requested information (such as sample sizes for test/training sets, number/qualifications of experts, adjudication methods, MRMC studies, effect sizes, specific ground truth types, etc.) is not applicable or available in this type of submission.

The document describes non-clinical testing performed to show conformance to standards and software validation, but it does not present a study designed to establish device performance against predefined acceptance criteria in the way one would for a diagnostic or AI-driven system.

However, I can extract information related to the device's characteristics and the non-clinical tests performed.

Here's a summary of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" and "reported device performance" in the sense of quantifiable metrics for diagnostic accuracy or clinical outcomes. Instead, it demonstrates compliance with international standards and describes functional principles and technical characteristics that are deemed substantially equivalent to predicate devices.

The "performance" is implicitly demonstrated through conformance to established standards and validation of software functionality, rather than through meeting specific numerical thresholds for a novel diagnostic claim.

Characteristic / Test	Acceptance Criteria (Implicit from Standards)	Reported Device Performance / Compliance
Electrical Safety	Conformance to international standards for electrical safety	Successfully tested and conforms to international standards.
Electromagnetic Compatibility (EMC)	Conformance to international standards for EMC	Successfully tested and conforms to international standards.
Biocompatibility	Demonstrably safe for intended use (based on established studies)	Biocompatibility studies completed; device is safe for its intended use.
Software Validation	Confirmation of device performance as designed	Software successfully validated to confirm performance.
Functional Principle	Similar to predicate devices (e.g., control speed/torque, irrigation)	Identical to predicate device (CHIROPRO L SYSTEM K092214)
Compliance to Standards	ISO 11498 type 2 (motor), ISO 14457, ISO 1797, ISO 3964 (handpieces)	Complies with these international standards.
Motor Torque	N/A (compared to predicate, not an AC)	5.5 Ncm (Predicate: 6.8 Ncm)
Max Speed (Handpieces)	N/A (compared to predicate, not an AC)	Up to 40,000 rpm (Predicate: Up to 50,000 rpm)
Flow Rate (Pump)	N/A (compared to predicate, not an AC)	30 - 110 ml/min (Predicate: 30 - 125 ml/min)

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

Sample Size for Test Set: Not applicable. The submission describes non-clinical engineering and bench testing (electrical safety, EMC, biocompatibility, software validation), not a clinical study with a "test set" of patients or data in the typical sense of evaluating diagnostic performance.
Data Provenance: The tests described are engineering and laboratory tests, not clinical data from patients. Therefore, information like "country of origin of data" and "retrospective or prospective" is not relevant.

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

Not applicable. There is no mention of "ground truth" or expert review in the context of establishing performance for a diagnostic or AI system. The "ground truth" for non-clinical tests would be the specifications and requirements of the relevant international standards.

4. Adjudication method for the test set

Not applicable, as there is no human review of a "test set" to establish ground truth.

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

Not applicable. This is not an AI-driven or diagnostic device that involves human readers interpreting cases.

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

Not applicable. This is a dental surgical system, not an algorithm or AI device. The software validation confirms the functional performance of the device's control unit, not an independent algorithm's diagnostic accuracy.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. For non-clinical tests, "ground truth" would be the defined specifications and parameters of the standards (e.g., a certain voltage, current, or biocompatibility threshold).

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that involves a training set.

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

Not applicable. There is no training set.

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 consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The logo is black and white.

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

August15, 2014

Kaltenbach & Voigt GmbH Mr. Stefan Trampler Head of Quality Management & Regulatory Affairs Bismarckring 39 Biberach, Germany, 88400

Re: K140308

Trade/Device Name: MASTERsurg/EXPERTsurg Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpieces and Accessories Regulatory Class: I Product Code: EBW, EGS Dated: May 15, 2014 Received: May 19, 2014

Dear Mr. Trampler:

We have reviewed vour 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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must

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Page 2 - Mr. Trampler

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 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" (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 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,

Mary S. Runner -S

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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Section IV - Indications for Use

K140308

510(k) Number (if known): K140308

Device Name: MASTERsurg / EXPERTsurg

Indications for Use:

EXPERTsurg:

This KaVo product is intended for surgery to expose and dissect oral tissue structures or endodontic treatments (e.g. periodontal gap, gingiva, bone, jaw, extractions and implantations).

INTRA LUX S600 LED:

The medical device is intended to drive / operate a dental handpiece / contra-angle handpiece equipped with a handpiece connection according to ISO 3964. This medical device is an electrical low-voltage motor for dental purposes according to ISO 11498 type 2 and classified as a type B application part.

SURGmatic S201 L / C; SURGmatic S201 XL / XC; SURGmatic S11 L / C:

The medical device is intended for the following uses: Surgery such as setting an implant, bone augmentation, sinus lift, tooth extraction procedures, implantology, osteotomia, root resection and oral, jaw and facial surgery.

Prescription Use X (Part 21 CFR 801 Subpart D) AND / OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Image /page/3/Picture/0 description: The image shows the logo for KaVo Dental Excellence. The logo consists of the text "KaVo. Dental Excellence." in a simple, sans-serif font. To the right of the text is a stylized graphic, possibly representing dental tools or abstract shapes, rendered in black and white.

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: May, 14th 2014

Device Name:

)

Trade Name MASTERsurg / EXPERTsurg .
- Common Name Controller, Foot, Handpieces and Cord (EBW)
  - Handpiece, Contra-Angle Attachment, Dental (EGS)
. Classification Name - Dental handpiece and accessories, per 21 CFR § 872.4200

Devices for Which Substantial Equivalence is Claimed:

CHIROPRO L SYSTEM (K092214) marketed by Bien-Air Dental SA .
. SURGICAL STRAIGHT & CONTRA-ANGEL HANDPIECES (K011061) marketed from W & H DENTALWERK BUERMOOS GMBH

Device Description:

The MASTERsurg / EXPERTsurg is a dental surgical system out of:

-EXPERTsurg (surgical control unit)
INTRA LUX S600 LED (surgical motor) -
SURGmatic S201 L / C (handpieces) •
SURGmatic S201 XL / XC (handpieces) -
SURGmatic S11 L / C (handpieces) -

The MASTERsurg / EXPERTsurg is a system out of a surgical control unit (EXPERTsurg), a surgical motor (INTRA LUX S600 LED) and different handpieces (SURGmatic).

The surgical control unit (EXPERTsurg) consists of a surgical controller, a motor cable, an instruments tray, a holder and a tube set. The surgical motor (INTRA LUX S600 LED) consists of the motor, a stopper for maintenance purposes and exchange O-rings for the motor coupling.

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As a functional principle the software-based surgical controls the speed and torque of a dental micro motor. The unit is equipped with a pump for the use with external irrigation tubing allowing irrigation of the working area. The surgical control unit is operated through the buttons on the tabletop console or via foot control. The surgical control unit is intended to be used with the INTRA LUX S600 LED motor. Straight or contra-angle handpieces with a handpiece connection according to ISO 3964 can be equipped. The instrument tray allows the dentist to deposit the SURGmatic handpieces in a safe position. The holder is intended to be used for general storage. The tube set is needed to deliver the external irrigation from the bottle (not part of this 510(k)) to the SURGmatic handpieces. A power cord provides electric power to the unit. The EXPERTsurg will be delivered with software on the surgical control unit. The EXPERTsurg follows the international standards for electrical safety and electromagnetic compatibility which are applicable for the use with human beings.

Each of the different handpieces (SURGmatic) consists of the handpiece, a spray clip (only SURGmatic S201 L / C and SURGmatic S201 XL / XC), a jet needle for cleaning purposes and a tube for the external spray.

The SURGmatic handpieces are electrical driven 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 (L version). The devices can be sterilized by the steam autoclave method. Through the INTRA LUX S600 LED motor connected to the surgical control unit, the SURGmatic handpieces equipped with a handpiece connection according to ISO 3964 receives the energy, the cooling water and air for treatment and the light for illumination the operation area (L version). Surgical burs and cutters (with straight handpiece shank or with contra-angle shank) according to ISO 1797 can be used with the SURGmatic handpieces. The SURGmatic handpieces use external spray allowing external irrigation to the working area. The mechanism of action for the SURGmatic handpieces is as follows. The dental straight and contra-angle handpieces are electrical-driven handpieces which will be supplied with energy, air and light through the dental micro motor of the surgical control unit. Dental burs (not part of this 510(k)) according to ISO 1797 could be inserted into the chuck system of the handpieces. Based on the speed adjusted in the surgical control unit the handpiece bur rotates up to 40,000 rpm. The SURGmatic handpieces interacts with the patient through a rotating bur with the patient teeth according to the intended use.

Intended Use of the Device:

EXPERTsurg:

This KaVo product is intended for surgery to expose and dissect oral tissue structures or endodontic treatments (e.g. periodontal gap, gingiva, bone, jaw, extractions and implantations).

INTRA LUX S600 LED:

SURGmatic S201 L / C; SURGmatic S201 XL / XC; SURGmatic S11 L / C:

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Substantial Equivalence:

The MASTERsurg / EXPERTsurg dental surgical system out of a surgical control unit (EXPERTsurg), a surgical motor (INTRA LUX S600 LED) and different handpieces (SURGmatic) is substantially equivalent to other legally marketed devices in the United States. The MASTERsurg / EXPERTsurg functions in a manner similar to and is intended for the same use as the CHIROPRO L SYSTEM (K092214) marketed by Bien-Air Dental SA and to the SURGICAL STRAIGHT & CONTRA-ANGEL HANDPIECES (K011061) marketed by W & H DENTALWERK BUERMOOS GMBH.

The EXPERTsurg surgical control unit together with the surgical motor (INTRA LUX S600 LED) is similar to the predicate device CHIROPRO L SYSTEM (K092214) from Bien-Air Dental SA in that it is a software-based surgical control unit which controls the speed and torque of a dental micro motor as the functional principle. As the CHIROPRO L SYSTEM (K092214) from Bien-Air Dental SA the EXPERTsurg surgical control unit together with the surgical motor (INTRA LUX S600 LED) consists of a surgical control unit, a foot controller, a surgical motor, an instruments tray, a holder and a tube set. The EXPERTsurg surgical control unit together with the surgical motor (INTRA LUX S600 LED) and the CHIROPRO L SYSTEM (K092214) from Bien-Air Dental SA are equipped with a pump for the use with external irrigation tubing allowing irrigation of the working area. The surgical control units are operated through the buttons on the tabletop console or via foot control. Both units are intended to be used with a dental micro motor equipped with straight or contra-angle handpiece connection according to ISO 3964 can be equipped. The CHIROPRO L SYSTEM (K092214) from Bien-Air Dental SA as well as the EXPERTsurg surgical control unit together with the surgical motor (INTRA LUX S600 LED) will be delivered with software and the devices follow the international standards for electrical safety and electromagnetic compatibility which are applicable for the use with human beings.

The SURGmatic (S201 L/C, S201 XL/XC and S11 L/C) handpieces are similar to the predicate devices SURGICAL STRAIGHT & CONTRA-ANGEL HANDPIECES (K011061) from W & H DENTALWERK BUERMOOS GMBH in that the dental straight and contra-andle handpieces are electrical-driven handpieces which will be supplied with energy, air and light through a dental micro motor of a surgical control unit as the mechanism of action. As the SURGICAL STRAIGHT & CONTRA-ANGEL HANDPIECES (K011061) from W & H DENTALWERK BUERMOOS GMBH the SURGmatic handpieces are reusable (The devices can be sterilized by the steam autoclave method) handoieces provided with a fiber optic light system (where applicable). Surgical burs and cutters (with straight handpiece shank or with contra-angle shank) according to ISO 1797 can be used for both, the SURGmatic handpieces and the SURGICAL STRAIGHT & CONTRA-ANGEL HANDPIECES (K011061) from W & H DENTALWERK BUERMOOS GMBH. In addition both handpiece types, the SURGmatic handpieces and the SURGICAL STRAIGHT & CONTRA-ANGEL HANDPIECES (K011061) from W & H DENTALWERK BUERMOOS GMBH use external spray allowing external irrigation to the working area.

The EXPERTsurg surgical control unit together with the surgical motor (INTRA LUX S600 LED) differ from the CHIROPRO L SYSTEM (K092214) marketed by Bien-Air Dental SA in a few technical characteristics (f.e. protection class, dimensions, flow rate of the pump, Motor Torque and weight).

The SURGmatic (S201 L/C, S11 L/C and S201 XL/XC) handpieces differ from the SURGICAL STRAIGHT & CONTRA-ANGEL HANDPIECES (K011061) marketed by W & H DENTALWERK BUERMOOS GMBH in a few technical characteristics (f.e. dimensions, light intensity and lubrication). The maximum speed of the SURGICAL STRAIGHT & CONTRA-ANGEL HANDPIECES (K011061) marketed by W & H DENTALWERK BUERMOOS GMBH is 50,000 rpm in difference to 40,000 rpm of the SURGmatic handpieces.

The differences do not render the device NSE because the performance tests demonstrates that the differences in technological characteristics do not raise different questions of safety and effectiveness than the predicate and show that the device is as safe and effective as the predicate.

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Summary of the Technological Characteristics:

DescriptiveInformation	Surgical control unit (EXPERTsurg) and Surgical motor (INTRA LUX S600 LED)
	EXPERTsurg +INTRA LUX S600 LED	Chiropro L System (K092214)(Bien-Air Dental SA)
Indicationsfor Use	Unit: This KaVo product is intended for surgeryto expose and dissect oral tissue structures orendodontic treatments (e.g. periodontal gap,gingiva,bone,jaw,extractionsandimplantations). Motor: The medical device isintended to drive / operate a dental handpiece /contra-angle handpieceequippedwithahandpiece connection according to ISO 3964.This medical device is an electrical low-voltagemotor for dental purposes according to ISO11498 type 2 and classified as a type Bapplication part.	The Chiropro L System is intended for use indental surgery, endodontics and implantology.The main unit is designed to operate a specificdental micro motor that drives dental handpiecesfitted with appropriate tools to cut hard and softtissues in the mouth and to screw dentalimplants.
Device Components	Surgical control unit with tubing + motor	Identical
Compliance toStandards	Electrical low voltage motor for dental purposesaccording to ISO 11498 type 2	Identical
Functional Principle	This surgical unit consists of a software-baseddrive unit that controls the speed and torque ofa dental micro motor. The unit is equipped witha pump for the use with external irrigationtubing allowing irrigation of the working area.The device is operated through the buttons onthe tabletop console or via foot control. Thesystem (unit and micro motor) is intended to beused with contra-angle handpieces or straightinstruments.	Identical
Insulation class	II	Identical
Protection class	IP20	IP40
Dimensions	265 x 255 x 100 mm	242 x 241 x 137 mm
Flow Rate (Pump)	30 - 110 ml / min.	30 - 125 ml / min.
Electrical SpecificationDevice (Voltage)	100 - 240 V	Identical
Electrical SpecificationDevice (Power)	230 VA	Unknown
Motor Type	Surgical Motor (collector)	Identical
Handpiece Connection	INTRAmatic Coupling System (ISO 3964)	Identical
Electrical SpecificationMotor (Voltage)	22 V AC	Unknown
Electrical SpecificationMotor (Torque)	5,5 Ncm	6,8 Ncm
Electrical SpecificationMotor (Rotation)	Clockwise, Counter Clockwise	Identical
Electrical SpecificationMotor (Speed)	Up to 40,000 rpm	Identical
Electrical SpecificationMotor (Light)	With built-in light system (LED)	Identical
Motor Weight	125 g	119 g
Intended Users	Dentists	Identical
DescriptiveInformation	Dental Handpieces (SURGmatic)
	SURGmatic S201 L / CSURGmatic S201 XL / XCSURGmatic S11 L / C	Surgical Straight & Contra-angle Handpieces(K011061)(W & H DENTALWERK BUERMOOS GMBH)
Indicationsfor Use	The medical device is intended for the followinguses: Surgery such as setting an implant, boneaugmentation, sinus lift, tooth extractionprocedures, implantology, osteotomia, rootresection and oral, jaw and facial surgery.	This medical device is intended for indications inthe field of implantology and surgery (f.e.osteotomia on the upper and lower jaw,germectomia, sequestrotomia, implantology,hemisection, wisdom tooth extraction, root tipresection, bone removal, surgical modellation,apical ventilation. Fenestration, bonemodellation)
Functional Principle	Through the micro motor connected to thesurgical unit the straight and contra-anglehandpieces / instruments equipped with ahandpiece connection according to ISO 3964receives the energy, the cooling water and airfor treatment and the light for illumination theoperating area.	Identical
Air / water ports	External Spray	Identical
Fiberoptics	With and Without built-in light system	Identical
Dimensions (with motor)	Headsize-Height: Up to 13,7 mmHeadsize-Diameter: Up to 9,8 mmFront diameter: Up to 7,3 mm	Unknown
Type of chuck	Push Button, lever chuck	Identical
Rotary Instruments	For Surgical Burs and Cutters (with straighthandpiece shank or with contra-angle shank)according to ISO 1797	Identical
Dimensions	Approx. 80 - 100 mm	Identical
Speed Range	Up to 40,000 rpm	Up to 50,000 rpm
Chemical composition ofthe patient-contactingportions of the device	(See details in Section XV)	Unknown
Chemical composition ofthe water / air lines	(See details in Section XV)	Unknown
Light Intensity	Approx. 25,000 LUX	Daylight
Bur retention force	Up to 22 Ncm (45 Ncm)	Identical
Compliance toStandards	Complies with ISO 14457, ISO 1797, ISO 3964	Identical
Lubricant	KaVo QUATTROcare (K071288)	Unknown (Own Lubricant from W&H)
Sterilization	Sterilizable(See details in Section XIV)	Identical

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Non-Clinical Test Data:

Temperature and energy tests according to the international standards for electrical safety and electromagnetic compatibility have been conducted to determine the conformance to the state of the art. Blocompatibility studies have been completed which demonstrate that the MASTERsurg / EXPERTsurg is safe for his intended use.

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Additionally, the MASTERsurg / EXPERTsurg software has been successfully validated to confirm the performance of the device.

Clinical Test Data:

Clinical testing has not been conducted on this product.

Conclusion:

Based upon the tests according to the international standards for electrical safety and electromagnetic compatibility, the biocompatibility studies, the similar technological / performance characteristics as compared to the predicate devices, and successful validation of the MASTERsurg / EXPERTsurg software, the performance of the MASTERsurg / EXPERTsurg is deemed to be substantially equivalent to the predicate devices.

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.