(218 days)
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.
W&H's reciprocating/oscillating handpieces were developed as dental contra-angle handpieces that are powered by either an air motor or an electric micromotor. The internally mounted gearing elements transmit the supplied rotational movement up to the head-side assembly holding the clamped tool and generating its reciprocal movement. Because of being designed for two different manufacturers´ files/tips (tools), the following types have been developed: the Synea Profin handpieces WG-67 LT and WG-67 A, intended to be provided with tips/files offered by the Swedish company Dentatus AB (Establishment Reg. No. 8030870) and the Synea Intensiv handpieces WG-68 A, WG-69 LT and WG-69 A (incl. Swiss Edition for WG-69 A and WG-69 LT), intended to be provided with tips/files offered by the Swiss manufacturer Intensiv SA (Establishment Reg. No. 8030958). All these devices´ application is intended in dentistry.
The provided text is a 510(k) Premarket Notification summary for dental handpieces. It does not describe an AI/ML medical device or a study involving human readers and AI assistance for diagnostic purposes. Therefore, most of the requested information regarding acceptance criteria, study design (sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance), and training set details for an AI/ML device cannot be extracted from this document.
The document focuses on demonstrating substantial equivalence of the new Synea Fusion Handpieces to a legally marketed predicate device (K082827) based on non-clinical testing for mechanical, material, and reprocessing characteristics, as well as biocompatibility.
Here's what can be extracted based on the provided text, and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not provide a specific table of acceptance criteria with reported performance values in the way one would for an AI/ML diagnostic device with performance metrics like sensitivity, specificity, or AUC. Instead, it states that "Non-clinical testing has been performed showing that the device performs as intended and are substantially equivalent to the predicate device (K082827)."
The acceptance criteria are implied by the standards applied and the successful completion of the tests:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with ISO 14457:2017 "Dentistry - Handpieces and motors" | Functional testing of the new handpieces to test the application, settings, and features per the device specifications requirements was performed, demonstrating performance as intended. This implies the device met the mechanical and functional requirements of this standard. |
| Biocompatibility according to ISO 10993-1 and ISO 7405 | "An evaluation of biocompatibility according to ISO 10993-1 was performed." This implies the device met the biocompatibility requirements, indicating no unacceptable biological response. |
| Reprocessing Validation according to FDA Guidance and specific ISO standards (ISO 17664, ANSI/AAMI ST79, ISO 17665-1) | "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." This indicates the device can be safely reprocessed, meeting the methods and acceptance criteria defined within those standards and guidance. |
| Risk Assessment according to ISO 14971 | "Risk Assessment according to ISO 14971:2007." This implies that risks were identified, evaluated, and controlled to an acceptable level as per the standard. |
| Durability/Lifetime, Torque, Functionality, Chemical Resistance, and Packaging Stability | "Additionally, different further tests, such as material tests (reg. chemical resistance), lifetime tests, torque and functionality test and tests for ensuring the stability of packaging were performed house-internally and confirmed the product's suitability for the use in practice." This implies the device met internal performance specifications for these characteristics. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable and therefore not provided in the document, as the testing was non-clinical (laboratory/bench testing) of physical devices, not data from patients for an AI/ML diagnostic system. There were no "test sets" of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable. Ground truth as typically understood for AI/ML diagnostic devices (e.g., radiologist reads, pathology) was not established for this type of device (dental handpieces). The "truth" for the performance criteria established was based on engineering specifications and adherence to international standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this was not a human-reader based study for diagnostic accuracy.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. No MRMC study was conducted, as this is not an AI-assisted diagnostic device. The document explicitly states "Clinical performance testing was not conducted."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For this device, "ground truth" refers to the established engineering specifications and validated test methods defined by the applied ISO standards and internal procedures. For example:
- Mechanical/Functional: Compliance with force, speed, and dimensional tolerances as defined by ISO 14457.
- Biocompatibility: Absence of toxic or adverse biological reactions based on validated assays defined by ISO 10993-1 and ISO 7405.
- Reprocessing: Successful elimination of microbial load and retention of functional integrity after reprocessing cycles, validated according to ISO 17664, ANSI/AAMI ST79, and ISO 17665-1.
8. The sample size for the training set
Not applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
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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.
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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
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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
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Indications for Use
Submission Number (if known)
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)
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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 GmbHIgnaz-Glaser-Strasse 53A - 5111 BürmoosAustriaPhone: 00436274 / 6236 -0Fax: 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 LTSwiss 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-anglehandpiece attachments"510(k) Number: K082827 (Decision Date: January 7th, 2009)Manufacturer: W&H Dentalwerk Bürmoos GmbH |
| W&H's reciprocating/oscillating handpieces were developed as dentalcontra-angle handpieces that are powered by either an air motor or anelectric micromotor. The internally mounted gearing elements transmitthe supplied rotational movement up to the head-side assembly holdingthe clamped tool and generating its reciprocal movement. | |
| Because of being designed for two different manufacturers´ files/tips(tools), the following types have been developed: | |
| Device Description | > |
| the Synea Profin handpieces WG-67 LT and WG-67 A, intended tobe provided with tips/files offered by the Swedish company DentatusAB (Establishment Reg. No. 8030870) | |
| and | |
| > | |
| the Synea Intensiv handpieces WG-68 A, WG-69 LT and WG-69 A(incl. Swiss Edition for WG-69 A and WG-69 LT), intended to beprovided with tips/files offered by the Swiss manufacturer Intensiv SA(Establishment Reg. No. 8030958). | |
| All these devices´ application is intended in dentistry. | |
| Indications for Use: | The reciprocating/oscillating contra-angle handpieces are for thefollowing applications:Preparation, removing protrusions or excess of filling materials andcements, finishing and polishing in the interdental, supragingival andsubgingival regions, plaque removal and IPR (interproximal reduction) inorthodontics. |
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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 AWG-69 LT / WG-69 AWG-69 LT / WG-69 A Swiss Edition | --- | |
| Manufacturer | W&H Dentalwerk Bürmoos GmbHEst. Reg. No.: 9681479 | W&H Dentalwerk Bürmoos GmbHEst. Reg. No.: 9681479 | identical | |
| marketed by | A-dec Inc. | W&H Dentalwerk Bürmoos GmbHDentatus AB,Reg. No. 8030870Intensiv SA,Reg. No. 8030958 | --- | |
| Regulatoryclass | Class I | Class I | identical | |
| Regulationno. | 872.4200 | 872.4200 | identical | |
| ProductCode | EFB | EFB | identical | |
| Use | Rx only | Rx only | identical | |
| 510(k)number | K082827 | K242179 | --- | |
| Indicationsfor use | The A-dec/W&H Synea Profinreciprocating contra-anglehandpiece attachment is intendedfor use in removing protrusions orexcess of filling materials andcements, preparation, finishing andpolishing in the interdental andsubgingival regions, stripping,vibrating of inlays using Dentatustips and root canal preparationsusing endodontic files. | The reciprocating/oscillating contra-angle handpieces are for thefollowing applications:Preparation, removing protrusions orexcess of filling materials andcements, finishing and polishing inthe interdental, supragingival andsubgingival regions, plaque removaland IPR (interproximal reduction) inorthodontics. | identical | |
| Appearance | WA-67/1.1 XXWA-67/0.4 XX | WG-67 XXWG-68 XXWG-69 XX: | equivalent | |
| HandpieceDimensions | WA-67/1.1 XX:94 x Ø 20,2 mm,head 8,2 mmWA-67/0.4 XX: | 94 x Ø 20,2 mm,WG-67 XX:head 8,2 mm | identical | |
| WG-68 XX:93,4 x Ø 20,2 mm,head 10 mmWG-69 XX: | equivalent | |||
| Drive / motorconnection | ISO 3964 | ISO 3964 | identical | |
| Max drivespeed | WA-67/1.1 XX:20.000 RPMWA-67/0.4 XX: | WG-67 XX:20.000 RPM | identical | |
| WG-68 XX:20.000 RPM | identical | |||
| WG-69 XX:40.000 RPM | similar *) | |||
| Gearing ratio | WA-67/1.1 XX:2:1WA-67/0.4 XX: | WG-67 XX:2:1 | identical | |
| WG-68 XX:1:1 | similar *) | |||
| WG-69 XX:2:1 | identical | |||
| Files/tips | PROFIN / Dentatus LDT and LTA | WG-67 XX: | Dentatus LTA,EVA, PER-IO-TOR | equivalent |
| WG-68 XX: | Intensiv Ortho-StripsSystem, Intensiv | new **) | ||
| WG-69 XX: | Proxoshape, IntensivBevelshape | |||
| File stroke | WA-67/1.1XX: | WG-67 XX: | 1,1 mm | identical |
| 1,1 mm | WG-68 XX: | 0,9 mm | new **) | |
| WA-67/0.4XX: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 becleaned and sterilized prior to firstuse and after each patient | sterilizable in autoclave. Must becleaned and sterilized prior to firstuse and after each patient | identical | |
| Lubrication | before each sterilization orafter 30 minutes of use oronce a day | before each sterilization orafter 30 minutes of use orat least twice daily | identical |
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*) 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 toISO 14457:2017 "Dentistry - Handpieces and motors"Biological Assessment / Cytotoxicity Testing according toISO 10993-1:2009 + Cor 1:2010 "Biological evaluation of medical devices – Part 1:Evaluation and testing"ISO 7405:2008 + A1:2013 "Dentistry - Evaluation of biocompatibility of medicaldevices used in dentistry"Reprocessing Tests under consideration ofISO 17664:2017 "Reprocessing of Health Care Products - Information to beprovided by the manufacturer for the processing of medical devices"ANSI/AAMI ST79:2010 + A1:2010 + A2:2011 + A3:2012 + A4:2013"Comprehensive guide to steam sterilization and sterility assurance in health carefacilities"ISO 17665-1:2006 "Sterilization of health care products - Moist heat - Part 1:Requirements for the development, validation and routine control of a sterilizationprocess for medical devices"Risk Assessment according toISO 14971:2007. "Medical devices - Application of risk management to medicaldevices"Additionally, different further tests, such as material tests (reg. chemicalresistance), lifetime tests, torque and functionality test and tests for ensuring thestability of packaging were performed house-internally and confirmed the product'ssuitability for the use in practice. |
|---|---|
| Clinical Testing | Clinical performance testing was not conducted. |
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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.
§ 872.4200 Dental handpiece and accessories.
(a)
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.(b)
Classification. Class I.