i-Polish is a cordless prophylaxis handpiece equipped with control buttons and wireless foot control for use with disposable prophylaxis angles in hygiene operatory to perform cleaning and polishing procedures on teeth surface and fillings.

Device Description

The Cordless Prophy system is a cordless handpiece which is intended for use by dental professionals for cleaning and polishing teeth. This is a general hygiene procedure that is performed on people of all ages in a professional dental operatory.

The Cordless Prophy System is comprised of a cordless, battery-powered handpiece, a removable and autoclavable outer sheath, an AC powered battery charging station, a battery-powered wireless foot control and an AC adapter. Accessories to the Cordless Prophy System include three style of Disposable Prophy Angle (DPA), which is cleared as Class I, Product code ESG, under premarket notification K030603.

Additionally, the handpiece of Cordless Prophy System must be used with a Disposable Sleeve, which is cleared as Class II, Product Code PEM, under premarket notification K151123.

The handpiece features a removable outer sheath that is to be cleaned and steam sterilized prior to first use and after each patient use.

The i-Polish has two speed control mode for operation:

. Foot control mode: One is using it with the wireless foot control, where the amount of vertical actuation on the wireless foot control correlates to the speed of the handpieces supplied to the DPA, the corresponding variable speed range of the DPA is controlled and adjusted through varying pressure on the foot control. The adjustable range is 500 rpm to 4000 rpm;
. Handpiece control mode: And the other uses a Centralized control button located on the handpieces for six constant speed level, 500 rpm, 1500 rpm, 1500 rpm, 2000 rpm, 3000 rpm and 4000 rpm.

AI/ML Overview

The provided text is a 510(k) summary for the Guilin Woodpecker Medical Instrument Co., Ltd. i-Polish Cordless Prophy System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving acceptance criteria for a novel AI/software device. Therefore, much of the requested information regarding acceptance criteria, study design, ground truth, and expert involvement is not available in this document.

However, I can extract information related to the device's performance, comparisons to predicate devices, and non-clinical testing.

Here's the information that can be extracted or inferred from the provided text, acknowledging that most of your request pertains to a different type of submission:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present "acceptance criteria" in the format of specific quantitative benchmarks. Instead, it details the device's technical specifications and compares them to a predicate device to argue for "substantial equivalence." The "performance" is described through these specifications and compliance with various safety and performance standards.

Feature	Acceptance Criteria (Inferred from Predicate/Standards)	Reported Device Performance (i-Polish)	Conclusion/Note
Primary Indication of Use	Cleaning and polishing procedures on teeth surface and fillings.	i-Polish is a cordless prophylaxis handpiece equipped with control buttons and wireless foot control for use with disposable prophylaxis angles in hygiene operatory to perform cleaning and polishing procedures on teeth surface and fillings.	Same as predicate.
Regulation Number	21 CFR 872.4200 (Dental Handpiece And Accessories)	872.4200	Same.
Product Code	EKX	EKX	Same.
Device Class	Class 1	1	Same.
Handpiece Power	Lithium-ion Battery, rechargeable	Lithium-ion Battery, rechargeable multiple times by AC/DC power supply.	Same.
Foot Control Power	Lithium-ion Battery, rechargeable	Lithium-ion battery, rechargeable multiple times by AC/DC power supply.	Same.
Lubrication Method	Lubricant Free Motor	Lubricant Free Motor. Do not use Lubrication.	Same.
Mode of Operation	Rotary	Rotary	Same.
Charge time (Handpiece)	Approximately 2 hours	Approximately 2.5 hours	Different, but complies with IEC62133-2:2017 and electrical safety IEC 60601-1:2015. No new safety/effectiveness issues.
Charge time (Foot control)	Approximately 3 hours	Approximately 2 hours	Different, but complies with IEC62133-2:2017 and electrical safety IEC 60601-1:2015. No new safety/effectiveness issues.
Handpiece Dimension	25mm Dia × 156mm	27.6mm Dia × 192mm	Different, but allows for similar user interaction and complies with ISO14457-2017. No new safety/effectiveness issues.
Prophy Angle Fit	Doriot style, allows most prophy angles	Disposable prophy angle (cleared under K030603)	Different, but does not impact user experience. No new safety/effectiveness issues.
Speed Control (Handpiece)	Not explicitly detailed in predicate comparison	Six constant speed levels: 500, 1000, 1500, 2000, 3000, 4000 rpm (via centralized button).	Different but delivers similar torque/speed profiles to predicate. Lower than reference device (K983413). No new safety/effectiveness issues.
Speed Control (Foot Control)	Varying pressure on foot pedal	Varying pressure on foot control, adjustable range 500 rpm to 4000 rpm.	Different but delivers similar torque/speed profiles to predicate. Lower than reference device (K983413). No new safety/effectiveness issues.
Speed Range (±10%)	500-3000 RPM	500-4000 RPM	Top speed higher than predicate, but lower than reference device. Comparison test carried out. No new safety/effectiveness issues.
Maximum Torque (±10%)	1Ncm	1.2Ncm	Similar.
Operating Environment	Ambient temperature: +10°C ~ +35°C; Relative humidity: 15% ~ 80%	Ambient temperature: +5°C ~ +40°C; Relative humidity: 30% ~ 75%; Atmospheric pressure: 70kPa ~ 106kPa	Different, but tested to conform with IEC 60601-1. No new safety/effectiveness issues.
Transport/Storage Condition	Ambient temperature: -20°C ~ +60°C; Relative humidity: 8% ~ 80%	Ambient temperature: -20°C ~ +55°C; Relative humidity: 10% ~ 93%; Atmospheric pressure: 70kPa ~ 106kPa	Different, but tested to conform with IEC 60601-1. No new safety/effectiveness issues.
Safety Standards Compliance	IEC 60601-1, IEC 60601-1-2, ISO 10993-5, ISO 10993-10, ISO 14457	IEC 60601-1, IEC 60601-1-2, IEC 80601-2-60, ISO 14457, ANSI/IEEE C63.27, FCC Part 15 Subpart C, IEC 62133-2, ISO 10993-5, ISO 10993-10	Compliant with these and additional standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document describes a premarket notification for a medical device (Cordless Prophy System) and focuses on demonstrating substantial equivalence through technical comparisons and non-clinical testing. It does not involve a "test set" of patient data as would be used for an AI/software device. The tests performed are engineering and biocompatibility evaluations.

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)

Not applicable. This is not an AI/software device relying on expert-annotated ground truth for performance evaluation on a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable.

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. This is not an AI-assisted diagnostic or interpretive device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The "ground truth" here is compliance with engineering standards, physical specifications, and performance characteristics for a dental handpiece, as demonstrated through non-clinical testing (e.g., electrical safety, EMC, biocompatibility).

8. The sample size for the training set

Not applicable. There is no AI/machine learning component requiring a training set mentioned in this document.

9. How the ground truth for the training set was established

Not applicable.

Summary

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December 17, 2021

Guilin Woodpecker Medical Instrument Co., Ltd. % Yoyo Chen Consultant Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square, Liuxian Avenue, Xili Town, Nanshan District Shenzhen, Guangdong 518100 China

Re: K211531

Trade/Device Name: Cordless Prophy System, Model: i-Polish Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I, reserved Product Code: EKX Dated: November 17, 2021 Received: November 29, 2021

Dear Yoyo Chen:

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 mediation-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,

For 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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K211531

Device Name Cordless Prophy System, Model: i-Polish

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)	☑ Remediation Under 21 CFR 1271 Subpart D☐ Use That Is Subject to 21 CFR 1271 Subpart C	☑ Remediation Under 21 CFR 1271 Subpart D	☑ Remediation Under 21 CFR 1271 Subpart D
☑ Remediation Under 21 CFR 1271 Subpart D	☑ Remediation Under 21 CFR 1271 Subpart D	☐ Use That Is Subject to 21 CFR 1271 Subpart C	☐ Use That Is Subject to 21 CFR 1271 Subpart C
☑ Remediation Under 21 CFR 1271 Subpart D
☐ Use That Is Subject to 21 CFR 1271 Subpart C

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

This summary of 510(K) information is submitted As Required by requirements of SMDA and 21 CFR §807.92.

1. Administrative Information

Submission Date	November 17, 2021
Manufacturerinformation	Guilin Woodpecker Medical Instrument Co., Ltd.Address:Information Industrial Park, Guilin National High-Tech Zone,Guilin, Guangxi, 541004, P.R. ChinaContact person: Ning Jiakang (宁加康)TEL: +86-773-2350532FAX:+86-773-2350532E-Mail: zmnbg03@glwoodpecker.com
SubmissionCorrespondent	Shenzhen Joyantech Consulting Co., Ltd.1713A, 17th Floor, Block A, Zhongguan Times Square, LiuxianAvenue, Xili Town, Nanshan District, Shenzhen, GuangdongProvince, China.Contact person: Ms. Yoyo ChenE-Mail: yoyo@cefda.com; field@cefda.comImage: Logo
Establishmentregistration number	3005581016

2. Device Information

Type of 510(k)Submission:	Traditional
510 (k) number	K211531
Device Name:	Cordless Prophy System
Model:	i-Polish
Classification Name:	Handpiece, Direct Drive, Ac-Powered
Review Panel:	Dental
Device Class:	1
Regulation Number:	872.4200
Product Code:	EKX

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3. Primary Predicate Device

Manufacturer	Young Dental Manufacturing Co 1, LLC
Device name	Young INFINITY Cordless Handpiece System
510(K) Number:	K171377
Regulation Description	Dental handpiece and accessories
Product Code	EKX

4. Reference Device

Manufacturer	Parkell Products Inc.
Device name	Low-Speed Prophy Handpiece
510(K) Number:	K983413
Regulation Description	Dental handpiece and accessories
Product Code	EKX

5. Device Description

Additionally, the handpiece of Cordless Prophy System must be used with a Disposable Sleeve, which is cleared as Class II, Product Code PEM, under premarket notification K151123.

The handpiece features a removable outer sheath that is to be cleaned and steam sterilized prior to first use and after each patient use.

The i-Polish has two speed control mode for operation:

. Foot control mode: One is using it with the wireless foot control, where the amount of vertical actuation on the wireless foot control correlates to the speed of the handpieces supplied to the DPA, the corresponding variable speed range of the DPA is controlled and adjusted through varying pressure on the foot control. The adjustable range is 500 rpm to 4000 rpm;
. Handpiece control mode: And the other uses a Centralized control button located on the handpieces for six constant speed level, 500 rpm, 1500 rpm, 1500 rpm, 2000 rpm,

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3000 rpm and 4000 rpm.

6. Intended use/Indication for use

7. Comparison with Predicate Device

Items	Subject Device(K211531)	Predicate Device(K171377)	Conclusion
Product Code	EKX	EKX	Same
Class	1	1	Same
Regulation number	872.4200	872.4200	Same
Intended use/Indicationfor use	i-Polish is a cordless prophylaxishandpiece equipped with controlbuttons and wireless foot controlfor use with disposableprophylaxis angles in hygieneoperatory to perform cleaning andpolishing procedures on teethsurface and fillings.	Battery driven electrical driveunit with wireless footcontroller for use withdisposable prophylaxis anglesin hygiene operatory toperform cleaning and polishingof tooth surfaces and fillings.	Same
Use	Rx Only	Rx Only	Same
Handpiece geometry	Cylindrical shape with reverseradius geometry to aid in devicehandling. Tapered, swivelednosecone area.	Cylindrical shape with reverseradius geometry to aid indevice handling. Tapered,swiveled nosecone area.	Same
Handpiece power	Lithium-ion Battery capable ofbeing recharged multipletimes by inclusion of an AC/DCpower supply.	Lithium-ion Battery capable ofbeing recharged multipletimes by inclusion of anAC/DC power supply.	Same
Foot control power	Foot control contains a Lithium-ion battery capable of beingrecharged multiple times byinclusion ofAC/DC power supply.	Foot control contains aLithium-ion battery capable ofbeing recharged multiple timesby inclusion ofAC/DC power supply.	Same
Charge time	Handpiece: Approximately 2.5hoursFoot control: Approximately 2hours	Handpiece: Approximately 2hoursFoot control: Approximately 3hours	Different(Note 1)
Handpiece Dimension	27.6mm Dia × 192mm	25mm Dia × 156mm	Different(Note 2)
Items	Subject Device (K211531)	Predicate Device (K171377)	Conclusion
Prophy Angle Fit	The device could be fit withDisposable prophy angle whichcleared under premarket notificationK030603.	Similar to most cordedhandpieces on the markettoday, our device will have aDoriot style nose which allowsmost prophy angles to beused on the device.	Different(Note 3)
Nose Cone(Also called as OuterSheath in the subjectdevice)	Outer sheath will swivel, theOuter sheath will also beremovable and autoclavable forinfection control.	Nose cone will swivel. Thenosecone will also beremovable and autoclavablefor infection control.	Same
InfectionControl/SterilizationMethod	Outer sheath is to be to cleanedand sterilized prior to first use andafter each patient. And thehandpiece is to be covered withan FDA cleared DisposableSleeve which is cleared as ClassII, Product Code PEM, underpremarket notification K151123.	Remove nosecone andsterilize via autoclave.The nosecose is to be cleanedand sterilized prior to first useand after each patient.Handpiece is to be coveredwith an FDA clearedDisposable Sleeve	Same
Lubrication Method	Lubricant Free Motor. Do not useLubrication	Lubricant Free Motor. Do notuse Lubrication	Same
User Interface onHandpiece	That handpiece will have aCentralized control button, whichwill enable connection to the footcontrol for activation.	That handpiece will have apower button, which will enableconnection to the foot pedal foractivation.	Same
Auto-off	The foot control and handpiece willautomatically shut down if thestandby time exceeds 5 minutes.The user would then have to pressthe Centralized control button toactivate the handpiece again.	Handpiece will enter a standbymode if idle for more than 4minutes. The user would thenhave to press the POWERbutton to activate thehandpiece again.	Similar
Mode of Operation	Rotary	Rotary	Same
Speed Control	i-Polish has two speed controlmode for operation.Handpiece control mode:Speed is controlled and adjustedthrough press the Centralizedcontrol button to achieve sixconstant speed level, 500 rpm,1000 rpm, 1500 rpm, 2000 rpm,3000 rpm and 4000 rpm.	Speed is controlled andadjusted through varyingpressure on the foot pedal.The motor itself has a limit of3000RPM (±10%).	Different(Note 4)
Items	Subject Device(K211531)	Predicate Device(K171377)	Conclusion
	Foot control mode:Speed is controlled and adjustedthrough varying pressure on thefoot control. The adjustable rangeis 500 rpm to 4000 rpm.
Speed Range (±10%)	500~4000 RPM	500-3000 RPM	Different(Note 4)
Maximum Torque(±10%)	1.2Ncm	1Ncm	Similar
Operating environment	Ambient temperature: +5°C ~+40°CRelative humidity: 30% ~ 75%Atmospheric pressure: 70kPa~106kPa	Ambient temperature: +10°C ~+35°C;Relative humidity: 15% ~ 80%	Different(Note 5)
Transport and StorageCondition	Ambient temperature: -20°C ~+55°CRelative humidity: 10% ~ 93%Atmospheric pressure: 70kPa~106kPa	Ambient temperature: -20°C ~+60°C;Relative humidity: 8% ~ 80%	Different(Note 5)
Compliance Standards	IEC 60601-1;IEC 60601-1-2;ISO 10993-5.ISO 10993-10.ISO 14457:	IEC 60601-1;IEC 60601-1-2;ISO 10993-5.ISO 10993-10.ISO 14457:	Same

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Note 1: Charge time

Although the charge time of the subject device is different with predicate device, but the battery is complied with the IEC62133-2:2017 standard, Otherwise, the subject device has been demonstrated to comply with the requirements of electrical safety IEC 60601-1:2015. This difference will not raise any new safety and effectiveness issues.

Note 2: Handpiece Dimension

The handpiece dimension has a little bit difference with predicate device, but both products allow for similar interaction with the user. Otherwise, the dimension of subject device has been demonstrated to comply with the requirements of ISO14457-2017standard. This difference will not raise any new safety and effectiveness issues.

Note 3: Prophy Angle Fit

The subject device only could be fit with Disposable prophy angle which cleared under premarket notification K030603. The prophy angle fit does not impact the user experience during cleaning and polishing procedures. This difference will not raise any new safety and effectiveness issues.

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Note 4: Speed Control, Speed Range

Although the speed of subject device could be controlled and adjusted through press the Centralized control button and varying pressure on the foot pedal. But both devices deliver similar torque and speed profiles.

The low-end speed limit(500RPM) is the same. The top speed (4000RPM) is much higher than the predicate device, but the top speed is still lower than a reference device K983413 (the claimed top speed is able to operate up to 5000 RPM). In addition, a comparison test carried out between subject device and predicate device to demonstrate the difference on the top speed will not arise new safety and effectiveness issues.

Otherwise, the subject device has been demonstrated to comply with the requirements of IEC 60601-1, ISO 80601-2-60, and IEC60601-1-2 standard requirement. The difference will not raise any new safety and effectiveness issues.

Note 5: Operating environment and Transport and Storage Condition

The difference will not raise new safety or effectiveness issue, because, the subject device has tested to conform with the IEC 60601-1 standard.

8. Non-Clinical Test Summary

8.1. Electromagnetic Compatibility and Electrical Safety Test

The subject device has passed safety testing in according to following standards.

IEC 60601-1:2005+AMD 1: 2012 Medical electrical equipment Part 1: General 1) requirements for basic safety and essential performance
1. IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 80601-2-60 Edition 2.0 2019-06 Medical electrical equipment Part 2-60: 3) Particular requirements for the basic safety and essential performance of dental equipment
1. ISO 14457: 2017 Dentistry - Handpieces and motors
1. ANSI/IEEE C63.27:2017 American National Standard for Evaluation of Wireless Coexistence
1. FCC Rules and Regulations, Part 15, Subpart C
1. The rechargeable lithium battery has passed the IEC 62133-2:2017 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary lithium cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems.

8.2. Biocompatibility Test

The subject device has passed safety testing in according to following standards.

1. ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro

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cytotoxicity

1. ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization

9. Software Validation

Software documentation consistent with moderate level of concern is submitted in this 510(k). System validation testing presented in this 510(k) demonstrates that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels

10. Clinical Data

Substantial equivalence does not depend on the clinical test data.

11. Conclusion

The subject device is substantially equivalent to the primary predicate device (K171377). This conclusion is based upon comparison on indication for use, technological characteristics, and applicable safety standards. Any difference in the technological characteristics does not raise any new issues or concerns of safety or effectiveness.

Regulation Number and Section

§ 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.