Proxeo ULTRA (PB-510, PB-520 and PB-530)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the FDA acronym with the full name of the agency on the right. The FDA part is in blue, with the acronym in a solid blue square and the full name written in a smaller font next to it. July 14, 2023 W&H Dentalwerk Buermoss GmbH Gerhard Weidler Regulatory Affairs Manager Ignaz-Glaser-Strasse 53 Buermoos, Salzburg 5111 AUSTRIA Re: K223173 Trade/Device Name: Proxeo ULTRA (PB-510, PB-520 and PB-530) Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: Class II Product Code: ELC Dated: June 21, 2023 Received: June 23, 2023 Dear Gerhard Weidler: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. {1}------------------------------------------------ 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. ## Michael E. Adjodha -S Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K223173 Device Name Proxeo ULTRA (PB-510, PB-520 and PB-530) Indications for Use (Describe) Drive unit with a piezoceramic oscillating system, which moves the tip in a linear oscillation. The drive unit is used for the removal of supragival calculus and subgingival concretions and for endodontic application and preparation of tooth enamel. Type of Use (Select one or both, as applicable) | <span style="font-family: Arial;"> <span style="font-size: 10pt;"> Prescription Use (Part 21 CFR 201 Subpart D) </span> </span> | |------------------------------------------------------------------------------------------------------------------------------------------| | <span style="font-family: Arial;"> <span style="font-size: 10pt;"> Over-The-Counter Use (21 CFR 201 Subpart C) </span> </span> | > Prescription Use (Part 21 CFR 801 Subpart D) __ Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. 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The text is stacked vertically, with "People" at the top, "have" in the middle, and "Priority" at the bottom. | DATE PREPARED | July 13, 2023 | |----------------|--------------------------------------------------------------------------------------------------------------------------------| | APPLICANT | W&H Dentalwerk Buermoos GmbH<br>Ignaz-Glaser-Straße 53<br>5111 Bürmoos<br>Austria<br>0043 - 6274/6236-0<br>0043 - 6274/6236-55 | | CONTACT PERSON | Mag. Dr. Gerhard Weidler<br>Regulatory Affairs Manager<br>0043 - 6274/6236-9339<br>gerhard.weidler@wh.com | #### 1 Device Name: | Trade Name: | Proxeo ULTRA (PB-510, PB-520 and PB-530) | |-----------------------------|------------------------------------------| | Common Name: | Proxeo ULTRA | | Device Classification Name: | Ultrasonic scaler | #### Classification / Product Code: വ The Proxeo ULTRA can be classified according to following device name and product code: | Device | Regulation<br>Description | Regulation<br>Medical<br>Specialty | Review<br>Panel | Product<br>Code | Regulation<br>Number | Device<br>Classification | |-----------------------|---------------------------|------------------------------------|-----------------|-----------------|----------------------|--------------------------| | Scaler,<br>Ultrasonic | Ultrasonic<br>scaler | Dental | Dental | ELC | 872.4850 | 2 | {4}------------------------------------------------ #### Predicate Device / Reference Device: 3 | Device | Predicate<br>Device | Reference<br>Device | 510(k)<br>Number | 510(k) Holder | |-----------------------|---------------------|---------------------|------------------|-------------------------------------------| | Scaler,<br>Ultrasonic | Multipiezo Pro | -------- | K140965 | Mectron Spa | | | -------- | Piezon 250 | K132445 | E.M.S. ELECTRO<br>MEDICAL SYSTEMS<br>S.A. | #### 4 Device Description: The Proxeo ULTRA is a drive unit including handpieces with a piezoceramic oscillating system, which moves the tip in a linear oscillation. The drive unit is used for the removal of supragingival calculus and subgingival concretions and for endodontic application and preparation of tooth enamel. The medical device consists of the following components that are also included in the scope of delivery: - > Control unit (PB-510, PB-520, and PB-530) - Handpiece (PB-5 L, PB-5 L, S, and PB-5 L Q) > - > Foot control (wired, wireless) - A Power supply, instruction for use and other accessories The scaler tips are moved with a piezo-scaler handpiece by converting electrical energy into mechanical vibration. The coolant (water) is directed to the treatment site via a solenoid valve and a control unit via the tip. The scaler tips are re-usable [diamond-coated tips are single use only] and delivered non-sterile. Tips for use with Piezo Scaler for the following dental applications: - V Scaling-tips - > Periodontic-tips - V Implant-cleaning-tips - > Endodontic-tips - > Tips for restoration and prosthetics With the foot control, corresponding device functions can be operated with the foot. These functions include, for example, program selection (button), operation of coolant function (button), motor direction of rotation selection (button), motor speed level (variable with pedal), power piezo handpiece (variable with pedal). Bluetooth Low Energy technology is used in the wireless foot controls (C-NW) to make this possible wirelessly as well. The foot controls are powered internally by a rechargeable battery (C-NW) or an external power source (C-NF). {5}------------------------------------------------ #### Indications for Use ട് Drive unit with a piezoceramic oscillating system, which moves the tip in a linear oscillation. The drive unit is used for the removal of supragingival calculus and subgingival concretions and for endodontics application and preparation of tooth enamel. #### Technological Characteristics 6 The technological characteristics of Proxeo Ultra are the technological characteristics of the predicate device. | | W&H Dentalwerk<br>Bürmoos GmbH –<br>Proxeo Ultra<br>(New Device) | Mectron Spa–<br>Multipiezo Pro<br>(Predicate Device) | EMS Electro Medical<br>Systems SA –<br>Piezon 250<br>(Reference Device) | Result | |-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Device<br>Name | Proxeo Ultra | Multipiezo Pro | Piezon 250 | --- | | Regulation<br>Number | 872.4850 | 872.4850 | 872.4850 | Identical | | Class | II | II | II | Identical | | Product<br>Code | ELC | ELC | ELC | Identical | | Regulation<br>Generic<br>Name | Ultrasonic scaler | Ultrasonic scaler | Ultrasonic scaler | Identical | | Indications<br>for Use | Drive unit with a<br>piezoceramic<br>oscillating system,<br>which moves the tip<br>in a linear oscillation.<br>The drive unit is used<br>for the removal of<br>supragingival<br>calculus and<br>subgingival<br>concretions and for<br>endodontic<br>application and<br>preparation of tooth<br>enamel. | The Multipiezo Pro and<br>Multipiezo are<br>piezoelectric ultrasonic<br>dental scalers intended<br>for use, with the<br>appropriate associated<br>tip inserts, in the<br>following dental<br>applications:<br>> Scaling: All general<br>procedures for<br>removal of<br>supragingival/subgi<br>ngival and<br>interdental<br>calculus/ plaque<br>deposits | The Piezon 250 is a<br>device for delivering<br>ultrasonic movement<br>and irrigant to a<br>stainless-steel tip<br>which is used by a<br>dentist or dental<br>hygienist. The<br>indications for use<br>are:<br>> Periodontal<br>pocket lavage<br>with<br>simultaneous<br>ultrasonic tip<br>movement | Equivalent | | | W&H Dentalwerk<br>Bürmoos GmbH –<br>Proxeo Ultra<br>(New Device) | Mectron Spa–<br>Multipiezo Pro<br>(Predicate Device) | EMS Electro Medical<br>Systems SA –<br>Piezon 250<br>(Reference Device) | Result | | | | > Periodontology:<br>Periodontal<br>therapy and<br>debridement for all<br>types of<br>periodontal<br>diseases, including<br>periodontal pocket<br>irrigation and<br>cleaning<br>> Endodontics: All<br>treatments for root<br>canal reaming,<br>irrigation, revision,<br>filling, gutta-percha<br>condensation and<br>retrograde<br>preparation<br>Restorative and<br>Prosthetics: All general<br>restorative procedures<br>including cavity<br>preparation, removal of<br>prostheses, amalgam<br>condensation, finishing<br>of crown preparations,<br>inlay/onlay<br>condensation,<br>implants/restorations<br>cleaning. | > Scaling and root<br>planning<br>Removal of supra<br>and subgingival<br>calculus and stains<br>from teeth | | | Functions | The basic function is<br>the conversion of<br>electrical energy into<br>mechanical energy<br>(linear oscillation). | The Multipiezo Pro<br>device is dental<br>piezoelectric ultrasonic<br>device that use<br>ultrasonic energy to<br>generate mechanical<br>micro-vibration of the<br>inserts to perform the<br>dental procedures<br>defined in their<br>intended use. | Ultrasonic scaling | Identical | | Sterility | Provided non-sterile | Provided non-sterile | Provided non-sterile | Identical | | | W&H Dentalwerk<br>Bürmoos GmbH –<br>Proxeo Ultra<br>(New Device) | Mectron Spa–<br>Multipiezo Pro<br>(Predicate Device) | EMS Electro Medical<br>Systems SA –<br>Piezon 250<br>(Reference Device) | Result | | Electric<br>power<br>supply | 100-230 V ± 10%<br>50-60 Hz | 100-240 VAC<br>50-60 Hz | 100-240 VAC<br>50-60 Hz | Equivalent | | Operating<br>Mode | Continuous<br>Operation | Continuous Operation | Continuous Operation | Identical | | Electric<br>classification | B | B | BF | Equivalent | | Ultrasonic<br>frequency | 22-35 kHz | 24-36 kHz | 24-32 kHz | Equivalent | | Foot control | > wireless<br>> wired | > wired | > wired | Equivalent | | Components | > Control Unit<br>> Handpiece (in<br>different versions)<br>> Foot control (in<br>different versions)<br>> Power supply,<br>instruction for use<br>> Scaler tips | > Control Unit<br>> Handpiece<br>> Foot control<br>> Power supply<br>> Scaler tips | > Control Unit<br>> Handpiece<br>> Foot control<br>> Instruments<br>> Irrigating liquid<br>bottle | Equivalent | #### 6.1 Device Characteristics Table {6}------------------------------------------------ {7}------------------------------------------------ #### 6.2 Summary of Technological Characteristics The proposed devices are similar in terms of design, operating principles and intended use and have similar technological characteristics as the predicate devices. The materials used on these devices are also used in the legally marketed predicate devices. #### Performance Data: 7 Non-clinical testing has been performed showing that the device performs as intended and are substantially equivalent to the predicate device (K140965) and the reference device (K132445). #### 7.1 Biocompatibility An evaluation of biocompatibility according to ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 10993-12, ISO 10993-17, ISO 10993-18 and ISO 10993-23 was performed. #### Electromagnetic Compatibility and Electrical Safety 7.2 Electrical safety and EMC testing were conducted. The Proxeo ULTRA is in compliance with IEC 60601-1, IEC 80601-2-60 as well as IEC 60601-1-2. {8}------------------------------------------------ #### 7.3 Re-processing Validation Reprocessing validation was provided per the FDA Guidance Document for "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling". Cleaning and intermediate level disinfection validation was provided for the control unit and foot controller. Cleaning and sterilization validation was provided for the scaler tips and handpieces. #### 7.4 Bench Testing Functional testing of the Proxeo ULTRA to test the application, settings, and features per the device specifications requirements. #### 8 Software: Software verification according to IEC 62304 and the FDA Guidance Document for Software Contained in Medical Device was conducted and the necessary software documentation according to the defined moderate level of concern was provided. #### Substantial Equivalence Summary / Conclusion: ி Based on available 510(k) information provided herein, our Proxeo ULTRA is considered to be substantially equivalent to the predicate device Multipiezo Pro and the reference device Piezon 250 in terms of indication for use, materials and technology, design and performance specifications.