ESTETICA Dental Treatment Unit and Accessories

{0}------------------------------------------------ Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 December 8, 2016 Kaltenbach & Voigt GmbH Stefan Trampler Director Regulatory Affairs Bismarckring 39 Biberach, Germany, 88400 Re: K161488 Trade/Device Name: ESTETICA Dental Treatment Unit and Accessories Regulation Number: 21 CFR 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: Class I Product Code: EIA Dated: November 4, 2016 Received: November 8, 2016 Dear Stefan 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. 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 and Part 809); medical device reporting (reporting of medical device-related 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 {1}------------------------------------------------ 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 and Part 809), 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, # Michael J. Ryan -S for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control. and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) K161488 Device Name ESTETICA Dental Treatment Unit and Accessories Type of Use (Select one or both, as applicable) Indications for Use (Describe) The ESTETICA Dental Treatment Unit and Accessories are intended to supply power to and serve as a base for other dental devices and accessories by providing air, water, vacuum and low voltage electrical power to dental instruments and dental handpieces. The ESTETICA Dental Treatment Unit and Accessories are designed for use by a trained professional in the field of general dentistry. | <span style="text-decoration: underline;"><b>Prescription Use (Part 21 CFR 801 Subpart D)</b></span> | | |------------------------------------------------------------------------------------------------------|--| | <span style="text-decoration: underline;"><b>Over-The-Counter Use (21 CFR 801 Subpart C)</b></span> | | CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*** The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image contains the logo for KaVo Dental Excellence. The logo features the company name in a simple, sans-serif font. Above the name is a stylized graphic, possibly representing dental tools or a stylized letter. The overall design is clean and professional, reflecting the company's focus on dental products and services. # 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: December 5, 2016 #### Device Name: - Trade Name ESTETICA Dental Treatment Unit and Accessories ● - . Common Name - Unit, Operative Dental - Classification Name Dental Operative Unit and Accessories, per 21 CFR § 872.6640 ● - Device Class Class I ● - Product Code - EIA Devices for Which Substantial Equivalence is claimed: TENEO Dental Treatment Unit and Accessories marketed by Sirona Dental Systems GmbH (K151045). - . Trade Name - TENEO Dental Treatment Unit and Accessories - Common Name Unit, Operative Dental ● - Classification Name Dental Operative Unit and Accessories, per 21 CFR § 872.6640 ● - Device Class Class I ● - Product Code - EIA, EBW #### Device Description: The ESTETICA Dental Treatment Unit and Accessories serves as a base that includes components to deliver air, water, electrical power, and vacuum to dental handpieces, instruments, and accessories. The device includes a patient chair, foot control, dentist element, assistant element and a water unit. The unit may also include a dental operating light and a monitor. Various handpieces and accessories can be added to the ESTETICA Dental Treatment Unit and Accessories. These include, but not limited to, pneumatic handpieces, electric motors with handpieces, scalers, intra-oral cameras, curing lights, air/water syringes and SE and HVE vacuum instruments. Per the Guidance for Industry and FDA Staff; Bundling Multiple Devices or Multiple Indications in a Single Submission, dated June 22, 2007, Kaltenbach & Voigt GmbH is bundling the ESTETICA Dental Treatment Unit and Accessories models listed below as the models do {4}------------------------------------------------ not differ significantly in purpose, design, materials, enerqy source, function or any other feature related to substantial equivalence. The device description and intended use are identical for all models listed below. The differences between the models and mounting configurations are cosmetic in nature such as size/shape of the delivery head, mount arms, upholsteries, instrument hangers, etc. which are listed in the Comparison Table below. All critical components within the ESTETICA Dental Treatment Unit and Accessories are common. The ESTETICA Dental Treatment Unit and Accessories are available in the following models which are offered in various mounting configurations: - ESTETICA E70 Vision T A - A ESTETICA E70 Vision C - ESTETICA E70 Vision S A - A ESTETICA E80 Vision T - ESTETICA E80 Vision C A - A ESTETICA E50 Life TM - ESTETICA E50 Life S A The designation letters listed at the end of each model represents the style of delivery as identified below. - > T/TM = Table/Table Mount: The handpiece/instrument tubing's hang below the dental unit. - > C = Cart: Cart mounted dental unit. - > S = Loops: The handpiece/instrument tubing's loops above the dental operative unit. | Feature | KaVo ESTETICA<br>E80 Vision | KaVo ESTETICA<br>E70 Vision | KaVo ESTETICA<br>E50 Life | |----------------------------------|------------------------------------|--------------------------------------|-----------------------------------------------| | Dentist element | 1: T-Table<br>2: Cart | 1: T-Table<br>2: Whip arm<br>3: Cart | 1: T-Table<br>2: Whip arm | | Control element | Control element -<br>Touch display | Control element -<br>Touch display | Control element -<br>Display and push buttons | | Instrument holder | 6 | 5 (6 optional) | 5 (6 optional) | | 1 x Multifunctional<br>handpiece | Standard | Optional | Optional | | 1 x Three function<br>handpiece | N/A | Standard | Standard | | Spray heating for<br>instruments | Standard | Standard | Standard | | Normtrays | Standard | Standard | Standard | | Assistant element | | | | | Control element | Glass touch<br>panel | Glass touch<br>panel | Control element<br>with push buttons | | Removable instrument<br>holder | Standard | Standard | N/A | # COMPARISON TARI F {5}------------------------------------------------ | Swivel- and height<br>adjustable | Standard | Standard | Standard | |------------------------------------------------------------------------------|------------------------------|----------------------------------------------------|----------------------------| | | | | | | Unit body | | | | | Instrument rinsing | Integrated<br>hygiene center | Integrated<br>hygiene center | Attached hygiene<br>center | | Hot water boiler for mouth<br>glass filling | Standard | Standard | Standard | | Spittoon (Glass or<br>Porcelain) | Motorized | Manual is<br>Standard,<br>Motorized is<br>optional | Manual | | Unit body color | Metallic and uni | Uni | Dental white | | | | | | | Patient chair | | | | | Patient chair | Suspended chair | Suspended chair | Floor-mounted<br>chair | | Motorized horizontal<br>movement and seat<br>elevation | Standard | N/A | N/A | | Backrest Progress | Standard | Standard | Standard | | Backrest Comfort | Standard | Standard | N/A | | Double-jointed headrest<br>with rotary control knob with<br>mechanical clamp | N/A | Standard | Standard | | Double-jointed headrest<br>with rotary control knob<br>with pneumatic clamp | Standard | Optional | N/A | | Motorized head rest | Optional | Optional | N/A | | Comfort head cushion | Optional | Optional | Optional | The various mounting configurations for the ESTETICA Dental Treatment Unit and Accessories are illustrated within the use and care manuals. The differences between the models are the ESTETICA 70 Vision and ESTETICA E80 Vision are the premier level dental operative units and the ESTETICA E50 Life is the mid-level dental operative unit. # Accessories: Optional accessories (devices) that are integrated / attached to the ESTETICA dental operative units have already been cleared by the FDA. Below are the accessories of the ESTETICA Dental Treatment Unit: | Accessory | Product Code | Comment | |-------------------------------------|--------------|----------------------------------------| | INTRA LUX KL 703 LED (motor) | EBW | FDA cleared under K103027 | | INTRA LUX S600 LED (motor) | EBW | FDA cleared under K140308 | | Multi-Function Handpieces (syringe) | ECB | Class I, exempt under 21 CFR 872.4565 | | Three-Function Handpieces (syringe) | ECB | Class I, exempt under 21 CFR 872.4565 | | CONEXIO (software) | EIA | Dental Operative Units and accessories | {6}------------------------------------------------ | ERGOcam One (camera) | EIA | Dental Operative Units and accessories<br>Only used for patient communication,<br>not for diagnosis | |---------------------------------|-----|-----------------------------------------------------------------------------------------------------| | Turbines | EFB | FDA cleared under K073478, K130560 | | Eletrical Handpieces | EFA | FDA cleared under K073478, K143465 | | SONICflex (ultrasonic scaler) | ELC | FDA cleared under K080089 | | Satelec Mini LED (curing light) | EBZ | FDA cleared under K032465 | | KaVolux 540 LED (dental light) | EAZ | Class I, exempt under 21 CFR 872.4630 | | DIAGNOcam 2170 | NTK | FDA cleared under K123402 | | PiezoLED (electrical scaler) | ELC | FDA cleared under K093000, K132443,<br>K140990 | | MULTIflex couplings | EFB | FDA cleared under K073478, K130560 | # Principle of Operation / Mechanism of Action: The ESTETICA Dental Treatment Unit and Accessories is designed to bring a patient into an ergonomic and comfortable position to perform dental treatment procedures. For this purpose, the patient chair can be brought into an appropriate position, either by activating the chair positioning motors or by recalled programmed positions set by the user. The headrest is adjusted manually by motor according to patient height and the area in the patient's oral cavity to be treated. The treatment is performed by the instruments placed in the designated instrument holders. The required parameters (e.g. power, torque, speed, coolinq media) can be adjusted via a panel / touch panel or recalled from settings programmed by the user beforehand. After taking an instrument from its respective holder, it can be activated via the foot control. To place dental hand instruments and materials required during treatment tray surfaces are provided. To dispose fluids and particles deriving from the oral cavity during treatment, suction hoses with attached instruments are provided on the assistant element. Selecting the suction instrument activates the vacuum. Also, a cuspidor bowl is available for patient rinse. The cuspidor can be manually swiveled towards the patient chair. The cuspidor bowl automatically returns after use to ensure that the patient does not collide with it during chair movements. An operating light providing illumination to the oral cavity can be switched on via the panel / touch screen or is operated automatically in accordance with preset adjustments in connection with the pre-programmed chair positions. It can be also switched on/off via a no-touch sensor which recognizes when the hand is moved there. Most chair and instrument related functions can be activated hands-free via foot control. The foot control is also available with wireless transmission. The panel / touch screen style user interface applies context-sensitivity; i.e. according to the actual operational state, varying buttons and functions are displayed and provided for use. Prescribed procedures and supporting components apply to facilitate infection control and maintaining water quality, such as automated suction hose and instrument hose purge, automatic dosage of waterline treatment and suction cleaning agents, integrated cleaning adapters for hoses. Water supply is also possible using systems. As an option the ESTETICA Dental Treatment Unit and Accessories can be equipped with an endodontic and / or surgery function. The endodontic function has an electronic torque limitation with variable torque modes (auto reverse, auto reverse forward and torque control only). The surgery function has different program steps according to the implantation activities (pilot drilling, form drilling, tapping, placing implant, setting a closure cap, marking and free use). {7}------------------------------------------------ Also a peristaltic pump and a NaCl bottle holder can be attached to the dentist element. The peristaltic pump prepares a sterile saline solution instead of spray water for cooling. This system connects as a "closed system" to the ESTETICA Dental Treatment Unit and Accessories to ensure full sterility. ESTETICA Dental Treatment Unit and Accessories has a motor-driven headrest, which can be moved via the touch screen and a 4-way switch at the backside of the headrest. Also a standard headrest is available which can be moved via mechanical adjustment. Both types of headrest allow the following adjustments: extension to adapt to the patient's stature, tilting for maxillary / mandibular treatment. Moreover, the removable head pad with magnetic holder allows shifting / rotation of the head support. # Statement of Intended Use: The ESTETICA Dental Treatment Unit and Accessories are intended to supply power to and serve as a base for other dental devices and accessories by providing air, water, vacuum and low voltage electrical power to dental instruments and dental handpieces. The ESTETICA Dental Treatment Unit and Accessories are designed for use by a trained professional in the field of general dentistry. # Substantial Equivalence: The ESTETICA Dental Treatment Unit and Accessories function in a manner similar to and are intended for the same use as the TENEO Dental Treatment Unit and Accessories (K151045) marketed by Sirona Dental Systems GmbH but does have different technological characteristics. However, these different technological characteristics do not raise new concerns of substantial equivalence. The performance data and testing of the ESTETICA Dental Treatment Unit and Accessories demonstrates substantial equivalence to the TENEO Dental Treatment Unit and Accessories (K151045). Hence, the device is deemed to be substantially equivalent. | Descriptive Information | ESTETICA Dental Treatment Unit and<br>Accessories | TENEO Dental Treatment Unit and Accessories<br>(K151045 - Sirona Dental Systems GmbH) | | |---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------| | Intended Use / Indications<br>for Use | The ESTETICA Dental Treatment Unit and<br>Accessories are intended to supply power to<br>and serve as a base for other dental devices<br>and accessories by providing air, water,<br>vacuum and low voltage electrical power to<br>dental instruments and dental handpieces.<br>The ESTETICA Dental Treatment Unit and<br>Accessories are designed for use by a trained<br>professional in the field of general dentistry. | This dental treatment unit with accessories is<br>intended to supply power to and serve as a<br>base for dental devices and accessories. This<br>product includes a dental chair. The dental<br>treatment unit is intended for use in the dental<br>clinic environment and is used by trained<br>dentists and/or dental assistants.<br>The motors serve as drives for rotating and<br>oscillating straight and contra-angle handpieces<br>in connection with a dental treatment unit. They<br>are used for endodontic and general dental<br>purposes.<br>The SPRAYVIT M multifunctional syringe is used<br>for dental treatment with unheated air and<br>heated water. It is also used to illuminate the<br>preparation field. | | | | | | | | Dentist Element | Positions | 6 handpiece positions + 1 additional | 6 handpiece positions + 1 additional | | | Max. Motors | Up to 4 motors<br>(electrical motors with and without light) | Up to 4 motors<br>(electrical motors with and without light) | | | User Interface | ESTETICA E70/E80 Vision: EasyTouch<br>Display, color, plus additional several keys<br>(foil) and Status LEDs<br>ESTETICA E50 Life: Display, with several keys<br>(foil) and Status LED | EasyTouch Display 7", color, plus<br>additional 13 keys (foil) and Status LEDs | | | | Hands free operation with cursor control by<br>foot control | Hands free operation with cursor control by foot<br>control | | | Syringe | Multifunctional syringe with internal heater for<br>water and light or 3 Functional syringe<br>without heater and light | Sprayvit M with internal heater for water and<br>light | | | Turbines | Turbines with light | Turbines with light | | | Control of Coolant | Water amount controlled by the unit | Water amount controlled by the unit | | | | Air amount controlled by the unit | Air amount controlled by the unit | | | Scaler | PiezoLED with light<br>PIEZOsoft without light | Sirosonic TL with light | | | Intraoral Camera | ERGOcam One | Sirocam AF+ | | | Curing Light | Mini LED (Acteon, Satelec) | Mini LED (Acteon, Satelec) | | | X-ray Viewer | Panorama X-ray image viewer or<br>small X-ray viewer | Panorama X-ray image viewer | | | Endodontic | Implantology functions | Implantology functions | | | | Endodontic treatment functions | Endodontic treatment functions | | | | Integrated (E70/E80 Vision) or adapted (E50<br>Life) pump for saline solution | Integrated pump for saline solution | | | | N / A | Integrated Apex locator function | | | Interfaces | USB Interface | USB Interface | | Assistant Element | Positions | 2/3 suction positions,<br>2 handpiece positions | 4 handpiece positions | | | User Interface | Touch pad (foil) with several keys and status<br>LEDs | Touch pad (foil) with 12 keys and status LEDs | | | Syringe | Multifunctional syringe with internal heater for<br>water and light or 3 Functional syringe<br>without heater and light | Sprayvit M with internal heater for water | | | Curing Light | Mini LED (Acteon, Satelec) | Mini LED (Acteon, Satelec) | | | Suction | Suction devices | Suction devices | | | | Saliva ejector | Saliva ejector | | | | HVE (High volume evacuator) | HVE (High volume evacuator) | | | | Surgical suction devices | Surgical suction devices | | | Interfaces | USB interface | USB interface | | | | N / A | Hydrocolloid port | | Chair | Patient load | ESTETICA E70/E80 Vision: 180 kg<br>ESTETICA E50 Life: 185kg (Standard Chair)<br>ESTETICA E50 Life: 135kg (Compact Chair) | Max. 160kg + 5 kg accessories | | | Headrest | Manually operated or motorized headrest | Motorized headrest | | | Upholstery | Skai upholstery | Thermo upholstery / lounge upholstery (sleek<br>style) | | | | | | | Water unit | Armrest | Armrest, retractable | Armrest removable | | | Switch | 4-way foot-switch | 4-way foot-switch | | | Movement | Synchronized Backrest and seat movements | Synchronized Backrest and seat movements | | | | N / A | External device connection | | | | N / A | Massage and lumbar support function | | | | User programmable positions | User programmable positions | | | | Backrest motor driven | Backrest motor driven | | | | ESTETICA E80 Vision: Horizontal movement,<br>seating bench lifting | N / A | | | | Seat and seat inclination motor driven | Seat and seat inclination motor driven | | Water unit | Cuspidor bowl | Manually adjustable or Motor driven cuspidor<br>bowl | Motor driven cuspidor bowl | | | Amalgam separator | Amalgam separator | Amalgam separator | | | Water…