PROXEO Twist Cordless Polishing System PL-40 H

K201703 · W&H Dentalwerk Buermoos GmbH · EKX · Feb 24, 2021 · Dental

Device Facts

• Record ID: K201703
• Device Name: PROXEO Twist Cordless Polishing System PL-40 H
• Applicant: W&H Dentalwerk Buermoos GmbH
• Product Code: EKX · Dental
• Decision Date: Feb 24, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

Battery driven electrical drive unit with wireless foot controller to perform cleaning and polishing of tooth surfaces and fillings.

Device Story

The PROXEO Twist Cordless Polishing System PL-40 H is a battery-powered dental handpiece used for cleaning and polishing tooth surfaces and fillings. The system comprises a cordless drive handpiece, a wireless foot controller, a handpiece holder, and a charging unit. The device operates by converting electrical energy from an internal Li-ion battery into mechanical rotary motion, which drives disposable prophy angles (DPAs). It is intended for use by dental professionals in a clinical environment. The operator controls the device via the wireless foot controller, which triggers the rotary motion. The device features an automatic standby mode after 4 minutes of inactivity. The healthcare provider uses the handpiece to perform routine dental prophylaxis, which benefits the patient by removing plaque and stains from tooth surfaces and restorations.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including ISO 14457 (handpieces), IEC 80601-2-60 and IEC 60601-1 (electrical safety), IEC 60601-1-2 and FCC Part 15 (EMC), IEC 62133 (battery safety), ISO 62304 (software), ISO 60601-1-6 (usability), ISO 10993-1 and ISO 7405 (biocompatibility), and reprocessing validation per ISO 17664, ANSI/AAMI ST79, and ISO 17665-1.

Technological Characteristics

Battery-powered (Li-ion, 3.7V, 680mAh) dental handpiece. Max speed 3,000 rpm; max torque 2 Ncm. Wireless foot controller (2.4 GHz range). Dimensions: 160 x 25 x 28 mm; weight 118g. Standards: ISO 14457, IEC 60601-1, IEC 60601-1-2, IEC 62133, ISO 10993-1, ISO 7405, ISO 17664, ISO 17665-1, ISO 14971.

Indications for Use

Indicated for cleaning and polishing of tooth surfaces and fillings in a dental setting.

Regulatory Classification

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.

Predicate Devices

• Young INFINITY Cordless Handpiece System (K171377)

Submission Summary (Full Text)

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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 and 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 24, 2021

W&H Dentalwerk Buermoos GmbH Johann Scharl Manager Regulatory Affairs Ignaz Glaser Strasse 53 Buermoos, Salzburg AT - 5111 Austria

Re: K201703

Trade/Device Name: PROXEO Twist Cordless Polishing System PL-40 H Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: Class I, reserved Product Code: EKX Dated: November 20, 2020 Received: November 27, 2020

Dear Johann Scharl:

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.

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

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental 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

510(k) Number (if known) K201703

#### Device Name

PROXEO Twist Cordless Polishing System PL-40 H

### Indications for Use (Describe)

Battery driven electrical drive unit with wireless foot controller to perform cleaning and polishing of tooth surfaces and fillings.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary

# K201703

| Submitter | W & H DENTALWERK BÜRMOOS GMBH<br>Ignaz-Glaser-Strasse 53<br>A - 5111 Bürmoos<br>Austria<br>Tel.: [phone]<br>Fax: [phone] / 6236 -55 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Registration Number | 9681479 |
| Contact Person | Ing. Johann Georg SCHARL |
| Date of Preparation | Feb. 22, 2021 |
| Device Name | PROXEO Twist Cordless Polishing System PL-40 H |
| Classification Name | Dental Handpiece and Accessories |
| Regulation Number | 872.4200 |
| Regulatory class | I |
| Product Code | EKX |
| Predicate Devices | Device Name: Young INFINITY Cordless Handpiece System<br>510(k) Number: K171377 (Decision Date: August 20th, 2018)<br>Manufacturer: Young Dental Manufacturing Co. |
| Device Description | The “PROXEO Twist Cordless Polishing System PL-40 H” is<br>an electrical drive unit for cleaning and polishing tooth<br>surfaces and fillings by use of Disposable Prophy Angles, so-<br>called "DPAs".<br>The system consists of<br>- the cordless drive handpiece PL-40 H,<br>- the wireless foot controller C-NW,<br>- a handpiece holder, and<br>- a charger inclusive adaptor.<br>Its basic function is the conversion of electrical energy into a<br>mechanical rotary motion. Power is supplied by a Li-ion<br>battery, which is assembled in the drive handpiece and can<br>be recharged by means of the provided charging cable. The<br>battery is not changeable by the user.<br>The device's application is intended in dentistry. |
| Indications for Use: | Battery driven electrical drive unit with<br>wireless foot controller to perform<br>cleaning and polishing of tooth surfaces and fillings. |

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| | | New device | Predicate<br>device | Judg-<br>ment |
|---------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| | Product Designation | PROXEO Twist<br>Cordless Polishing<br>System PL-40 H | Young INFINITY<br>Cordless Handpiece<br>System | different |
| | 510k number | K201703 | K171377 | different |
| | Manufacturer | W&H Dentalwerk<br>Buermoos GmbH<br>Reg. No.: 9681479 | Young Dental<br>Manufacturing Co.<br>Reg. No. 1941138 | different |
| | Regulation Number | 21 CFR 872.4200 | 21 CFR 872.4200 | same |
| | Product Code | EKX | EKX | same |
| | Regulatory Class | Class I | Class I | same |
| | Use | RX only | RX only | same |
| Comparison:<br>Technological<br>Characteristics | Indications for Use | Battery driven<br>electrical drive unit with<br>wireless foot controller<br>to perform cleaning<br>and polishing of tooth<br>surfaces and fillings. | Battery driven electrical<br>drive unit with wireless<br>foot controller for use<br>with disposable<br>prophylaxis angles in<br>hygiene operatory to<br>perform cleaning and<br>polishing of tooth<br>surfaces and fillings. | equivalent |
| | appearance | Image: PROXEO Twist Cordless Polishing System PL-40 H | Image: Young INFINITY Cordless Handpiece System | equivalent<br>(different<br>marking) |
| | Handpiece drive | PL-40 H | (PL-40 H) | (same) |
| | Battery type: | Li-Ion | Li-Ion | same |
| | Runtime: | 8 treatments with a<br>polishing duration of 6<br>min. | 8 treatments with a<br>polishing duration of 6<br>min. | same |
| | Standby: | automatically after 4<br>min. | automatically after 4<br>min. | same |
| | Charging time: | approx. 2 h | approx. 2 h | same |
| | Rated voltage: | 3,7 V | 3,7 V | same |
| | Rated capacity: | 680 mAh | 680 mAh | same |
| | Max. speed: | 3.000 rpm | 3.000 rpm | same |
| | Maximum torque: | 2 Ncm | 2 Ncm | same |
| | Dimensions<br>(W x D x H): | 160 x 25 x 28 mm | 160 x 25 x 28 mm | same |
| | Weight: | 118 g | 118 g | same |
| | | New device | Predicate<br>device | Judg-<br>ment |
| | Foot control | C-NW | (C-NW) | (same) |
| | Battery type: | Li-ion | Li-ion | same |
| | Runtime: | approx. 2 months | approx. 2 months | same |
| | Standby: | automatically if not<br>actuated | automatically if not<br>actuated | same |
| Comparison: | Charging time: | approx. 3 h | approx. 3 h | same |
| | Rated voltage: | 3.7 V | 3.7 V | same |
| Technological<br>Characteristics | Rated capacity: | 680 mAh | 680 mAh | same |
| | Dimensions (WxDxH): | 117 x 117 x 38 mm | 117 x 117 x 38 mm | same |
| | Weight: | 190 g | 190 g | same |
| | Charger:<br>Rated voltage: | 100 - 240 V | 100 - 240 V | same |
| | Permissible voltage<br>fluctuation: | $\pm$ 10 % | $\pm$ 10 % | same |
| | Frequency: | 50 - 60 Hz | 50 - 60 Hz | same |
| | Power: | 7 VA | 7 VA | same |
| Comparison:<br>New device<br>versus<br>Predicate device | The target field of application, the intended use, performance parameter and<br>material are the same or, at least, quite similar to those of the predicate device.<br>The differences are restricted to the devices' labelling: the type designations and<br>the devices' as well as their manufacturers' names are differently indicated on the<br>products themselves, on their packaging, Instructions for Use, etc.<br>Seen from the technological point of view, the products are identical.<br>The above-mentioned differences do not have any negative effect on the<br>substantial equivalence.<br>Therefore, the new device is substantially equivalent to the predicate device. | | | |

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| Non-clinical testing | Type testing according to<br>ISO 14457:2017 “Dentistry – Handpieces and motors"<br>Electrical Safety Tests according to<br>IEC 80601-2-60:2012-02 “Medical electrical equipment – Part<br>2-60: Particular requirements for the basic safety and<br>essential performance of dental equipment"<br>and<br>IEC 60601- 1:2005, 3rd Ed. + Corr.1:2006 + Corr2:2007<br>as well as<br>IEC 60601-1: 2012, 3.1 Ed.<br>"Medical electrical equipment – Part: General requirements<br>for safety" |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Electromagnetic Compatibility Test according to<br>IEC 60601-1-2:2014 “Medical electrical equipment - Part 1-2:<br>General requirements for basic safety and essential<br>performance - Collateral standard: Electromagnetic<br>compatibility - Requirements"<br>and<br>FCC 47CFR Part 15 C § 15.247 "Operation within the bands<br>902-928 MHz, 2400-2483.5 MHz, and 5725-5850 MHz" |
| | Safety Tests according to<br>IEC 62133:2012 + Corr1:2013 "Secondary cells and batteries<br>containing alkaline or other non-acid electrolytes - Safety<br>requirements for portable sealed secondary cells, and for<br>batteries made from them, for use in portable applications" |
| | Software validation according to<br>IEC 62304:2006 + A1:2015 "Medical device software –<br>Software life-cycle processes". |
| | Usability validation according to<br>IEC 60601-1-6:2010 + A1:2015 “Medical electrical equipment<br>– Part 1-6: General requirements for basic safety and<br>essential performance - Collateral standard: Usability" |
| | Biological Assessment / Cytotoxicity Testing according to<br>ISO 10993-1:2009 + Cor 1:2010 "Biological evaluation of<br>medical devices - Part 1: Evaluation and testing"<br>and<br>ISO 7405:2008 + A1:2013 "Dentistry – Evaluation of<br>biocompatibility of medical devices used in dentistry" |
| Non-clinical testing | Reprocessing Tests under consideration of<br>ISO 17664:2017 “Reprocessing of Health Care Products -<br>Information to be provided by the manufacturer for the<br>processing of medical devices”<br>and<br>ANSI/AAMI ST79:2010 + A1:2010 + A2:2011 + A3:2012 +<br>A4:2013 “Comprehensive guide to steam sterilization and<br>sterility assurance in health care facilities”<br>as well as<br>ISO 17665-1:2006 “Sterilization of health care products –<br>Moist heat - Part 1: Requirements for the development,<br>validation and routine control of a sterilization process for<br>medical devices”<br>Risk Assessment according to<br>ISO 14971:2007. “Medical devices - Application of risk<br>management to medical devices”<br>Additionally, different further bench tests, such as material<br>tests (reg. chemical resistance), life time tests, torque and<br>functionality test and tests for ensuring the stability of<br>packaging were performed house-internally and confirmed<br>the product's suitability for the use in practice. |
| Clinical Testing | Clinical performance testing was not conducted.<br>W&H considers the PROXEO Twist Cordless Polishing<br>System PL-40 H to be substantially equivalent to the<br>predicate device listed above. |
| Conclusion | This conclusion is based on the similarities in intended use,<br>principles of operation, functional design and structure.<br>Differences between the devices shown in the comparison<br>section above are minor and do not have any negative effect<br>on equivalence. |

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