MASTERTORQUE LUX 8900 L

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image contains the logo for KaVo Dental Excellence. The logo features the letters 'K' and 'V' in a stylized font, with the 'K' appearing larger and more prominent. Below the logo, the words 'KaVo. Dental Excellence.' are printed in a smaller, simpler font. # 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: August, 28th 2013 SEP 27 2013 Device Name: - Trade Name MASTERtorque LUX 8900 L . - Common Name Dental handpiece and accessories � - Classification Name Dental handpiece and accessories, per 21 CFR § 872.4200 � # Devices for Which Substantial Equivalence is Claimed: - ◆ SUPERTORQUE HIGH-SPEED HANDPIECES (K073478) - HIGH SPEED AIR TURBINE HANDPIECES, PAR-4HEX/4HX SERIES, TWIN Power (K061701) ### Device Description: The MASTER orque LUX 8900 L air-driven handpieces are dental handpieces for the use by a trained professional in the field of general dentistry. The devices are air-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 MULTIflex coupling connected to a dental unit, the MASTERtorque LUX 8900 L receives the air for high speed turbine, the cooling water and air for cutting treatment through pouring holes and light for illumination the operation area. The MASTERtorque LUX 8900 L is equipped with the Direct Stop Technology which reduces the stopping time of the high speed turbine and so of the bur. The back suction also will be reduced due to the Direct Stop Technology. Additionally the MASTERtorque LUX 8900 L will be supplied with an exchange filter for the water lines inside of the dental air-driven handpiece. The exchange filter filters the spray water inside the product. The filter is considered to be a spare part. If there is an insufficient amount of cooling water out of the MASTERtorque LUX 8900 L according to the instructions.for use, this spare has to be exchanged. Further one there is a jet needle supplied with the MASTERtorque LUX 8900 L. By using this part the operator is able to clean the spray holes in the head of the product if there is an insufficient amount of cooling water out of the MASTERtorque LUX 8900 L according to the instructions for use. Sec 5 - 1 {1}------------------------------------------------ The KaVo MULTIflex connectors (f.e. MULTIflex coupling 465 LED) are accessories to the medical device which will not be delivered together with the MASTERtorque LUX 8900 L. The MULTIflex connectors carry the air for the high speed turbine, the cooling water and air for cutting treatment and light for illumination from the dental treatment unit to the MASTERtorque LUX 8900 L. The mechanism of action for the MASTERtorque LUX 8900 L is as follows. The dental handpieces / turbine MASTERtorque LUX 8900 L is an air-driven handpiece which will be supplied with water, air and light through the tube and the MULTIflex coupling of a dental treatment unit. Based on the air pressure the turbine rotates up to 400.000 roms. Dental burs (not part of this 510(k)) according to ISO 1797-1 type 3 could be inserted into the chuck system of the turbine. The MASTERtorque LUX 8900 L interacts with the patient through a rotating bur with the patient teeth according to the intended use. ## Intended Use of the Device: The MASTERtorque LUX 8900 L is intended 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. They are designed for use by a trained professional in the field of general dentistry. #### Substantial Equivalence: The MASTERtorque LUX 8900 L functions in a manner similar to and is intended for the same use as the SUPERTORQUE HIGH-SPEED HANDPIECES marketed by Kaltenbach & Voigt GmbH and to the HIGH SPEED AIR TURBINE HANDPIECES, PAR-4HEX/4HX SERIES, TWIN Power marketed by J. MORITA USA, INC. The MASTERtorque LUX 8900 L is similar to the two (2) predicate devices in that it is a dental air-driven handpiece for the use by a trained professional in the field of general dentistry. The MASTERtorque LUX 8900 L is substantially equivalent in design, application and function to the two (2) predicate devices noted above. All three devices, the MASTERtorque LUX 8900 L and the two (2) predicate devices are reusable and ergonomically shaped. The devices can be sterilized by the steam autoclave method. Based on the run-down behavior the MASTERtorque LUX 8900 L is similar to the HIGH SPEED AIR TURBINE HANDPIECES, PAR-4HEX/4HX SERIES, TWIN Power. Both devices are equipped either with the Direct Stop Technology or with the Quick stop. In addition the MASTERtorque LUX 8900 L and both predicate devices receives the air for their high speed turbines and the cooling water / air for cutting treatment through the tube and the specific coupling of a dental unit. The MASTERtorque LUX 8900 L.differs from the SUPERTORQUE HIGH-SPEED HANDPIECES and the HIGH SPEED AIR TURBINE HANDPIECES, PAR-4HEX/4HX SERIES, TWIN Power in that the MASTERtorque LUX 8900 L is only available with a fiber optic light system for illumination of the operation area. Furthermore the MASTERtorque LUX 8900 L differs from the SUPERTORQUE HIGH-SPEED HANDPIECES by having the Direct Stop Technology which reduces the stopping time of the high speed turbine and so of the bur. Additionally the back suction will be reduced due to this Direct Stop Technology. The differences do not render the device NSE because the performance tests demonstrates that the differences in technological characteristics (turbine only with light and the Direct Stop technology) 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. {2}------------------------------------------------ # Summary of the Technological Characteristics: . | Descriptive Information | MASTERtorque LUX 8900 L | SUPERTORQUE HIGH-<br>SPEED HANDPIECES<br>(K073478) | HIGH SPEED AIR TURBINE<br>HANDPIECES, PAR-<br>4HEX/4HX SERIES, TWIN<br>Power (K061701) | |-----------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------| | Indications<br>for Use | The MASTERtorque LUX 8900<br>L is intended for the removal<br>of carious material, reducing<br>of hard tooth structure, cavity<br>and crown preparations,<br>removal of fillings, processing<br>and finishing tooth<br>preparations, restorations,<br>and for polishing teeth. They<br>are designed for use by a<br>trained professional in the<br>field of general dentistry. | Identical | Identical<br>(The PAR-4HEX/ 4 HX series<br>handpiece is for use by<br>authorized persons in the<br>practice of the dentistry.) | | Principle of operation | Through the tube and the<br>MULTIflex coupling connected<br>to a dental unit, the air-<br>powered handpiece receives<br>the air for high speed turbine,<br>the cooling water and air for<br>cutting treatment through<br>pouring holes and light for<br>illumination the operation<br>area. | Identical | Identical | | Air / water ports | Up to four (4) | Identical | Three (3) | | Fiberoptics | With built-in light system | With and without built-in light<br>system | With and without built-in light<br>system | | Dimensions | Headsize-Height: 13.0 mm<br>Headsize-Diameter: 12,5 mm | Headsize-Height: 15,0 mm<br>Headsize-Diameter: 13,0 mm | Headsize-Height: 13,2 mm<br>Headsize-Diameter: 10,5 mm | | Type of chuck | Push Button | Identical | Identical | | Power (approx.) | 23 watts | 18 watts | 22 watts | | Coupling Dimensions | Length with coupling:<br>Approx. 141 mm | Length with coupling:<br>Approx. 130 mm | Length with coupling:<br>Approx. 122,5 mm | | Chemical composition of the<br>patient-contacting portions of<br>the device | Stainless steel<br>(See details in Section XV) | German silver and stainless<br>steel | Information not available | | Chemical composition of the<br>water / air lines | Stainless steel, german silver<br>(nickel - chromium coated),<br>PEEK and Fluoride Rubber<br>Viton<br>(See details in Section XV) | German silver and stainless<br>steel | Information not available | | Light Intensity | Approx. 25,000 LUX | Identical | Identical | | Bur retention force | Up to 24 Ncm | Identical | Information not available | | Operating Pressure | 30 - 61 psi (41 psi<br>recommended) | > 40 psi recommended | 19 - 42 psi (35 psi<br>recommended) | | Idling Speed | 340,000 - 400,000 rpms | Approx. 350,000 rpms | 340,000 - 400,000 rpms | | Run-down behavior | Direct Stop | Not applicable | Quick Stop | . {3}------------------------------------------------ | Compliance to Standards | Complies with ISO 7785-1.<br>ISO 7405 and ISO 9168 | Identical | Identical | |-------------------------|----------------------------------------------------|-----------|---------------------------| | Lubricant | KaVo QUATTROcare<br>(K071288) | Identical | Information not available | #### Non-Clinical Test Data: Performance tests according to the international standards for dental air-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 MASTERtorque LUX 8900 L is safe for his intended use. ## Clinical Test Data: Clinical testing has not been conducted on this product. ### Conclusion: Based upon the tests according to the international standards for dental air-driven handpieces, the biocompatibility and sterilization studies and the similar technological / performance characteristics as compared to the predicate devices, the performance of the MASTERtorque LUX 8900 L is deemed to be substantially equivalent to the predicate devices. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized caduceus, a symbol often associated with medicine and healthcare. The symbol consists of three lines that curve and converge, with a wavy line at the bottom. DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 27, 2013 Kaltenbach & Voight GmbH Stefan Trampler Head of Quality Management & Regulatory Affairs Bismarckring 39 BIBERACH GERMANY 88400 Re: K130560 Trade/Device Name: MASTERtorque LUX 8900 L Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: August 28, 2013 Received: August 29, 2013 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. {5}------------------------------------------------ Page 2 - Mr. Trampler 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/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 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/Resourcesfor You/Industry/default.htm. Sincerely vours. MaryS.Runner -S Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ K130560 # Section IV - Indications for Use 510(k) Number (if known): Device Name: MASTERtorque LUX 8900 L Indications for Use: The MASTERtorque LUX 8900 L is intended for the removal of carlous material, reducing of hard tooth structure, cavity and crown 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. Prescription Use X (Part 21 CFR 801 Subpart D) AND / OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C) Andrew 1. Stee 2013.09.27 (PI.EASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Sec 4 - 1