MASTERSURG / EXPERTSURG
Device Facts
| Record ID | K140308 |
|---|---|
| Device Name | MASTERSURG / EXPERTSURG |
| Applicant | Kaltenbach & Voigt GmbH |
| Product Code | EBW · Dental |
| Decision Date | Aug 15, 2014 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.4200 |
| Device Class | Class 1 |
| Attributes | Therapeutic |
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.
Device Story
MASTERsurg/EXPERTsurg is a dental surgical system comprising a control unit (EXPERTsurg), surgical motor (INTRA LUX S600 LED), and various handpieces (SURGmatic). The system is used by dentists in clinical settings for oral/maxillofacial surgery and endodontics. The control unit, operated via tabletop console or foot pedal, regulates motor speed and torque; it includes an integrated pump for external irrigation of the surgical site. The motor drives handpieces connected via ISO 3964 interface, which hold surgical burs/cutters (ISO 1797) for tissue dissection or implant placement. The system provides power, cooling, and LED illumination to the handpiece. By controlling rotational speed (up to 40,000 rpm) and irrigation, the device assists the clinician in precise tissue removal and surgical site management, potentially improving procedural efficiency and patient outcomes.
Clinical Evidence
No clinical data. Bench testing only, including electrical safety, electromagnetic compatibility, and biocompatibility studies. Software validation was performed.
Technological Characteristics
System includes surgical control unit, surgical motor (collector type), and handpieces. Complies with ISO 11498 (motor), ISO 14457, ISO 1797, and ISO 3964. Features: 100-240V power, 22V AC motor, 40,000 rpm max speed, 5.5 Ncm torque, LED illumination, and external irrigation pump (30-110 ml/min). Handpieces are steam-autoclavable. Software-based control of speed/torque. Insulation class II, IP20 protection.
Indications for Use
Indicated for dental surgery, endodontic treatments, and implantology procedures including bone augmentation, sinus lift, tooth extraction, osteotomia, and root resection in adult patients requiring oral, jaw, or facial surgical intervention.
Regulatory Classification
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.
Predicate Devices
Reference Devices
- KaVo QUATTROcare (K071288)
Submission Summary (Full Text)
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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:
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.
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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:
| Descriptive<br>Information | Surgical control unit (EXPERTsurg) and Surgical motor (INTRA LUX S600 LED) | |
|-----------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | EXPERTsurg +<br>INTRA LUX S600 LED | Chiropro L System (K092214)<br>(Bien-Air Dental SA) |
| Indications<br>for Use | Unit: This KaVo product is intended for surgery<br>to expose and dissect oral tissue structures or<br>endodontic treatments (e.g. periodontal gap,<br>gingiva,<br>bone,<br>jaw,<br>extractions<br>and<br>implantations). Motor: The medical device is<br>intended to drive / operate a dental handpiece /<br>contra-angle handpiece<br>equipped<br>with<br>a<br>handpiece connection according to ISO 3964.<br>This medical device is an electrical low-voltage<br>motor for dental purposes according to ISO<br>11498 type 2 and classified as a type B<br>application part. | The Chiropro L System is intended for use in<br>dental surgery, endodontics and implantology.<br>The main unit is designed to operate a specific<br>dental micro motor that drives dental handpieces<br>fitted with appropriate tools to cut hard and soft<br>tissues in the mouth and to screw dental<br>implants. |
| Device Components | Surgical control unit with tubing + motor | Identical |
| Compliance to<br>Standards | Electrical low voltage motor for dental purposes<br>according to ISO 11498 type 2 | Identical |
| Functional Principle | This surgical unit consists of a software-based<br>drive unit that controls the speed and torque of<br>a dental micro motor. The unit is equipped with<br>a pump for the use with external irrigation<br>tubing allowing irrigation of the working area.<br>The device is operated through the buttons on<br>the tabletop console or via foot control. The<br>system (unit and micro motor) is intended to be<br>used with contra-angle handpieces or straight<br>instruments. | 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 Specification<br>Device (Voltage) | 100 - 240 V | Identical |
| Electrical Specification<br>Device (Power) | 230 VA | Unknown |
| Motor Type | Surgical Motor (collector) | Identical |
| Handpiece Connection | INTRAmatic Coupling System (ISO 3964) | Identical |
| Electrical Specification<br>Motor (Voltage) | 22 V AC | Unknown |
| Electrical Specification<br>Motor (Torque) | 5,5 Ncm | 6,8 Ncm |
| Electrical Specification<br>Motor (Rotation) | Clockwise, Counter Clockwise | Identical |
| Electrical Specification<br>Motor (Speed) | Up to 40,000 rpm | Identical |
| Electrical Specification<br>Motor (Light) | With built-in light system (LED) | Identical |
| Motor Weight | 125 g | 119 g |
| Intended Users | Dentists | Identical |
| Descriptive<br>Information | Dental Handpieces (SURGmatic) | |
| | SURGmatic S201 L / C<br>SURGmatic S201 XL / XC<br>SURGmatic S11 L / C | Surgical Straight & Contra-angle Handpieces<br>(K011061)<br>(W & H DENTALWERK BUERMOOS GMBH) |
| Indications<br>for Use | The medical device is intended for the following<br>uses: Surgery such as setting an implant, bone<br>augmentation, sinus lift, tooth extraction<br>procedures, implantology, osteotomia, root<br>resection and oral, jaw and facial surgery. | This medical device is intended for indications in<br>the field of implantology and surgery (f.e.<br>osteotomia on the upper and lower jaw,<br>germectomia, sequestrotomia, implantology,<br>hemisection, wisdom tooth extraction, root tip<br>resection, bone removal, surgical modellation,<br>apical ventilation. Fenestration, bone<br>modellation) |
| Functional Principle | Through the micro motor connected to the<br>surgical unit the straight and contra-angle<br>handpieces / instruments equipped with a<br>handpiece connection according to ISO 3964<br>receives the energy, the cooling water and air<br>for treatment and the light for illumination the<br>operating 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 mm<br>Headsize-Diameter: Up to 9,8 mm<br>Front diameter: Up to 7,3 mm | Unknown |
| Type of chuck | Push Button, lever chuck | Identical |
| Rotary Instruments | For Surgical Burs and Cutters (with straight<br>handpiece shank or with contra-angle shank)<br>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 of<br>the patient-contacting<br>portions of the device | (See details in Section XV) | Unknown |
| Chemical composition of<br>the 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 to<br>Standards | Complies with ISO 14457, ISO 1797, ISO 3964 | Identical |
| Lubricant | KaVo QUATTROcare (K071288) | Unknown (Own Lubricant from W&H) |
| Sterilization | Sterilizable<br>(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.
