Synea Fusion Handpieces (Intensiv & Profin)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. February 28, 2025 W&H Dentalwerk Bürmoos GmbH Gerhard Weidler Regulatory Affairs Manager Ignaz-Glaser-Straße 53 Bürmoos, Salzburg 5111 AUSTRIA Re: K242179 Trade/Device Name: Synea Fusion Handpieces (Intensiv & Profin) Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: Class I, reserved Product Code: EFB Dated: February 3, 2025 Received: February 3, 2025 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 (the 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 available 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}------------------------------------------------ Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory {2}------------------------------------------------ assistance/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 Adjodha, MChE, RAC, CQIA 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 {3}------------------------------------------------ ### Indications for Use Submission Number (if known) K242179 Device Name Synea Fusion Handpieces (Profin & Intensiv) WG-67 A. WG-67 LT. WG-68 A. WG-69 A. WG-69 LT. WG-69 A Swiss Edition, WG-69 LT Swiss Edition Indications for Use (Describe) The reciprocating/oscillating contra-angle handpieces are for the following applications: Preparation, removing protrusions or excess of filling materials and cements, finishing and polishing in the interdental, supragingival and subgingival regions, plaque removal and IPR (interproximal reduction) in orthodontics. Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ### 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." {4}------------------------------------------------ W&H Dentalwerk Bürmoos GmbH Synea Fusion Handpieces 510(k) Premarket Notifications # 510(k) Summary K242179 Image /page/4/Picture/2 description: The image shows a logo with the letters W, &, and H inside of a silver hexagon. The letters are also silver. The background of the logo is white. People have Priority | Submitter | W&H Dentalwerk Bürmoos GmbH<br>Ignaz-Glaser-Strasse 53<br>A - 5111 Bürmoos<br>Austria<br>Phone: 00436274 / 6236 -0<br>Fax: 00436274 / 6236 -55 | |----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Registration Number | 9681479 | | Contact Person | Mag. Dr. Gerhard Weidler | | Date of Preparation | 29.01.2025 | | Trade Name | Synea Fusion Handpieces (Intensiv & Profin) | | | Reciprocating/oscillating handpieces: | | Device Name | WG-67 LT, WG-67 A, WG-68 A, WG-69 LT, WG-69 A, WG-69 LT<br>Swiss Edition, WG-69 A Swiss Edition | | Classification Name | Dental Handpiece and Accessories | | Regulation Number | 872.4200 | | Regulatory class | 1 | | Product Code | EFB | | Predicate Devices | Device Name: "A-dec/W&H Synea Profin reciprocating contra-angle<br>handpiece attachments"<br>510(k) Number: K082827 (Decision Date: January 7th, 2009)<br>Manufacturer: W&H Dentalwerk Bürmoos GmbH | | | W&H's reciprocating/oscillating handpieces were developed as dental<br>contra-angle handpieces that are powered by either an air motor or an<br>electric micromotor. The internally mounted gearing elements transmit<br>the supplied rotational movement up to the head-side assembly holding<br>the clamped tool and generating its reciprocal movement. | | | Because of being designed for two different manufacturers´ files/tips<br>(tools), the following types have been developed: | | Device Description | > | | | the Synea Profin handpieces WG-67 LT and WG-67 A, intended to<br>be provided with tips/files offered by the Swedish company Dentatus<br>AB (Establishment Reg. No. 8030870) | | | and | | | > | | | the Synea Intensiv handpieces WG-68 A, WG-69 LT and WG-69 A<br>(incl. Swiss Edition for WG-69 A and WG-69 LT), intended to be<br>provided with tips/files offered by the Swiss manufacturer Intensiv SA<br>(Establishment Reg. No. 8030958). | | | All these devices´ application is intended in dentistry. | | Indications for Use: | The reciprocating/oscillating contra-angle handpieces are for the<br>following applications:<br>Preparation, removing protrusions or excess of filling materials and<br>cements, finishing and polishing in the interdental, supragingival and<br>subgingival regions, plaque removal and IPR (interproximal reduction) in<br>orthodontics. | {5}------------------------------------------------ ### 1 Comparison: | | Predicate Devices | New Devices | Judgment | | |-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|------------| | | A-dec/W&H Synea | W&H Synea Fusion | | | | Device name | Profin | Profin / Intensiv | --- | | | | Reciproc. contra-angle handpiece | Reciproc. contra-angle handpiece | | | | | WA-67/1.1 LT / WA-67/1.1 A | WG-67 LT / WG-67 A | | | | Type | WA-67/0.4 LT / WA-67/0.4 A | WG-68 A<br>WG-69 LT / WG-69 A<br>WG-69 LT / WG-69 A Swiss Edition | --- | | | Manufacturer | W&H Dentalwerk Bürmoos GmbH<br>Est. Reg. No.: 9681479 | W&H Dentalwerk Bürmoos GmbH<br>Est. Reg. No.: 9681479 | identical | | | marketed by | A-dec Inc. | W&H Dentalwerk Bürmoos GmbH<br>Dentatus AB,<br>Reg. No. 8030870<br>Intensiv SA,<br>Reg. No. 8030958 | --- | | | Regulatory<br>class | Class I | Class I | identical | | | Regulation<br>no. | 872.4200 | 872.4200 | identical | | | Product<br>Code | EFB | EFB | identical | | | Use | Rx only | Rx only | identical | | | 510(k)<br>number | K082827 | K242179 | --- | | | Indications<br>for use | The A-dec/W&H Synea Profin<br>reciprocating contra-angle<br>handpiece attachment is intended<br>for use in removing protrusions or<br>excess of filling materials and<br>cements, preparation, finishing and<br>polishing in the interdental and<br>subgingival regions, stripping,<br>vibrating of inlays using Dentatus<br>tips and root canal preparations<br>using endodontic files. | The reciprocating/oscillating contra-<br>angle handpieces are for the<br>following applications:<br>Preparation, removing protrusions or<br>excess of filling materials and<br>cements, finishing and polishing in<br>the interdental, supragingival and<br>subgingival regions, plaque removal<br>and IPR (interproximal reduction) in<br>orthodontics. | identical | | | Appearance | WA-67/1.1 XX<br>WA-67/0.4 XX | WG-67 XX<br>WG-68 XX<br>WG-69 XX: | equivalent | | | Handpiece<br>Dimensions | WA-67/1.1 XX:<br>94 x Ø 20,2 mm,<br>head 8,2 mm<br>WA-67/0.4 XX: | 94 x Ø 20,2 mm,<br>WG-67 XX:<br>head 8,2 mm | identical | | | | | WG-68 XX:<br>93,4 x Ø 20,2 mm,<br>head 10 mm<br>WG-69 XX: | equivalent | | | Drive / motor<br>connection | ISO 3964 | ISO 3964 | identical | | | Max drive<br>speed | WA-67/1.1 XX:<br>20.000 RPM<br>WA-67/0.4 XX: | WG-67 XX:<br>20.000 RPM | identical | | | | | WG-68 XX:<br>20.000 RPM | identical | | | | | WG-69 XX:<br>40.000 RPM | similar *) | | | Gearing ratio | WA-67/1.1 XX:<br>2:1<br>WA-67/0.4 XX: | WG-67 XX:<br>2:1 | identical | | | | | WG-68 XX:<br>1:1 | similar *) | | | | | WG-69 XX:<br>2:1 | identical | | | | | | | | | Files/tips | PROFIN / Dentatus LDT and LTA | WG-67 XX: | Dentatus LTA,<br>EVA, PER-IO-TOR | equivalent | | | | WG-68 XX: | Intensiv Ortho-Strips<br>System, Intensiv | new **) | | | | WG-69 XX: | Proxoshape, Intensiv<br>Bevelshape | | | File stroke | WA-67/1.1<br>XX: | WG-67 XX: | 1,1 mm | identical | | | 1,1 mm | WG-68 XX: | 0,9 mm | new **) | | | WA-67/0.4<br>XX:<br>0,4 mm | WG-69 XX: | | | | Light | types "LT": yes / types "A": no | types "LT": yes / types "A": no | | identical | | Spray | yes | yes | | identical | | Sterilization | sterilizable in autoclave. Must be<br>cleaned and sterilized prior to first<br>use and after each patient | sterilizable in autoclave. Must be<br>cleaned and sterilized prior to first<br>use and after each patient | | identical | | Lubrication | before each sterilization or<br>after 30 minutes of use or<br>once a day | before each sterilization or<br>after 30 minutes of use or<br>at least twice daily | | identical | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ {6}------------------------------------------------ *) The differences in the handpiece´s maximum drive speed and gearing ratio are caused by the tip manufacturers' recommendations. **) Different manufacturer (Intensiv SA) of files for the new handpieces, but identical clinical applications. Safety and effectiveness of the new handpieces are not affected. #### Summary of Technological Characteristics 1.1 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. ### 2 Applied standards: | Non-clinical testing | Type testing according to<br>ISO 14457:2017 "Dentistry - Handpieces and motors"<br><br>Biological Assessment / Cytotoxicity Testing according to<br>ISO 10993-1:2009 + Cor 1:2010 "Biological evaluation of medical devices – Part 1:<br>Evaluation and testing"<br><br>ISO 7405:2008 + A1:2013 "Dentistry - Evaluation of biocompatibility of medical<br>devices used in dentistry"<br><br>Reprocessing Tests under consideration of<br>ISO 17664:2017 "Reprocessing of Health Care Products - Information to be<br>provided by the manufacturer for the processing of medical devices"<br><br>ANSI/AAMI ST79:2010 + A1:2010 + A2:2011 + A3:2012 + A4:2013<br>"Comprehensive guide to steam sterilization and sterility assurance in health care<br>facilities"<br><br>ISO 17665-1:2006 "Sterilization of health care products - Moist heat - Part 1:<br>Requirements for the development, validation and routine control of a sterilization<br>process for medical devices"<br><br>Risk Assessment according to<br>ISO 14971:2007. "Medical devices - Application of risk management to medical<br>devices"<br><br>Additionally, different further tests, such as material tests (reg. chemical<br>resistance), lifetime tests, torque and functionality test and tests for ensuring the<br>stability of packaging were performed house-internally and confirmed the product's<br>suitability for the use in practice. | |----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Clinical Testing | Clinical performance testing was not conducted. | {7}------------------------------------------------ ### Performance Data: 3 Non-clinical testing has been performed showing that the device performs as intended and are substantially equivalent to the predicate device (K082827). ### 3.1 Biocompatibility An evaluation of biocompatibility according to ISO 10993-1 was performed. ### 3.2 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 sterilization validation was performed for the new handpieces. #### 3.3 Performance Testing Functional testing of the new handpieces to test the application, settings, and features per the device specifications requirements was performed. #### 4 Substantial Equivalence Summary / Conclusion: Based on available 510(k) information provided herein, the Synea Fusion Handpieces (Profin, Intensiv) are considered substantially equivalent to the predicate devices in terms of indications for use, technology and performance specifications. There are no differences between the devices which may raise new issues concerning safety or effectiveness.