The SD500 High Speed Handpiece Series is used by trained dental professionals for a variety of procedures including but not limited to caries and amalgam removal, restorative work and crown preparations.

Device Description

The SD500 High-Speed Handpiece Series includes a fiber optic high speed handpiece, to be marketed as a SD500 Elite Handpiece and a non-fiber optic handpiece, to be marketed as a SD500 Pro Handpiece. Both the Elite and the Pro versions are available as lubefree or lubricated turbine handpieces. Each is a pneumatically driven handheld device with multiport water spray that is capable of reaching rotational speeds of 367,200 – 448,800 rpms at a recommended air pressure of 38 to 43 PSI. The series delivers a range of 39 - 50 watts of power providing .28 oz.-in. of stall torque at 43 psi. The handpieces are constructed of stainless steel, including the internal air and water tubes, which provide drive air to the turbine assembly and cooling water to the work site. The handpiece also uses PEEK in its construction. The handpieces incorporate either a lubefree ceramic bearing turbine assembly or a lubricated ceramic bearing turbine assembly. Both versions of the turbine assembly use a push button autochuck. The stainless steel and aluminum air driven turbine assembly provides rotation to the bur. The SD500 High-Speed Handpiece Series uses a quick disconnect coupler that allows easy connection to the dental line delivery tubing. This coupler allows for easy rotation of the handpieces when attached to the tubing. These couplers include both fiber optic and nonfiber optic versions with Type 3 or 2 connections. The fiber optic version uses LED technology to deliver the light to the handpiece. All couplers are autoclavable. The burs used with the SD500 High Speed Handpiece Series are ISO 1797-1, type 2 burs. Only burs with hardened, tempered steel shanks or carbide shanks should be used. All handpieces in this series incorporate RFID (radio frequency identification) technology. This passive RFID tag does not have a built-in energy source. The RFID tag will allow the practitioner to track the device within the office only if the practitioner has a separate reader. A reader will enable the practitioner to track such things as usage and maintenance.

AI/ML Overview

This document describes a 510(k) premarket notification for the SD500 High Speed Handpiece Series. It is a submission for a dental handpiece, which is a Class I reserved device. As such, the information provided focuses on demonstrating substantial equivalence to predicate devices, primarily through engineering and material characteristic comparisons and adherence to relevant industry standards, rather than clinical study results establishing diagnostic accuracy or comparative effectiveness with human readers.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies, organized according to your request:

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

The provided document doesn't explicitly state numerical "acceptance criteria" in the way one might see for a diagnostic device (e.g., "sensitivity > 90%"). Instead, the performance evaluation is based on meeting the requirements of recognized industry standards and demonstrating comparable performance to predicate devices. The "reported device performance" is largely described qualitatively or by reference to meeting these standards.

Acceptance Criteria (Implied by Standards/Predicate Comparison)	Reported Device Performance (SD500 High Speed Handpiece Series)
Mechanical/Operational Performance Standards:	Complies with ISO 14457:2017 Dentistry Handpieces and Motors.
Electrical Safety Standards:	Complies with IEC 60601-1:2005 Medical Electrical Equipment – Part 1: General requirements for basic safety and essential performance.
Sterilization Efficacy:	Sterilization validation performed in accordance with ANSI/AAMI ST79:2010 & A4:2013, AAMI/ANSI/ISO 14937:2009, and ANSI/AAMI ST81:2004 (R2010).
Cleaning & Disinfection Efficacy:	Cleaning and disinfection validation conducted per FDA Guidance Document for "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" (March 17, 2015).
Biocompatibility:	Materials (Stainless steel, PEEK, Ceramic bearings) are "widely known and used within the dental and medical device industry." (No specific biocompatibility testing reported for the device, relying on established use of materials).
Risk Management:	Risk analysis developed using ISO14971:2012 Medical devices – Application of risk management to medical devices.
Rotational Speed:	Capable of reaching 367,200 – 448,800 rpms at a recommended air pressure of 38 to 43 PSI. (Comparable to predicate device 430 Torque which is 360,000 to 450,000 rpms at 38-43 PSI).
Power/Stall Torque:	Delivers a range of 39 - 50 watts of power providing 0.28 oz.-in. of stall torque at 43 psi. (Comparable to predicate device 430 Torque which delivers on average 20 watts of power providing 0.269 oz.-in. of stall torque).

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

The document refers to "bench testing" and "test results" to demonstrate conformity with standards like ISO 14457 and IEC 60601-1.

Sample Size: No specific numerical sample size is provided for these bench tests. This is typical for engineering performance testing of mechanical devices where testing is often done on a representative number of units to ensure consistency and compliance with specifications.
Data Provenance: The tests were "conducted to evaluate the functional performance and safety." Given this is a 510(k) submission by DentalEZ Inc., located in Lancaster, Pennsylvania, USA, the testing was likely conducted in-house or by a contracted laboratory within the US or a region adhering to these international standards. The data is prospective as it was generated specifically for this submission.

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 product is a dental handpiece, not an AI or diagnostic imaging device. Therefore, the concept of "ground truth" and "experts used to establish ground truth" with qualifications like "radiologist with 10 years of experience" does not apply in the context of this submission. The performance of the device is assessed against engineering specifications and industry standards, not against expert interpretations of diagnostic outputs.

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

Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human judgment (e.g., expert review of medical images). Since this submission pertains to a mechanical device and its performance against engineering standards, no adjudication method as described would be applicable or necessary. Performance is measured objectively through physical tests.

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

No MRMC comparative effectiveness study was done. This type of study is relevant for AI-powered diagnostic tools where human readers are involved in interpreting results, with or without AI assistance. The SD500 High Speed Handpiece Series is a direct therapy/procedural device, not a diagnostic or AI-assisted system.

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

No standalone algorithm performance study was done. This device does not involve any algorithms or AI for diagnostic or interpretive purposes. Its performance is entirely mechanical and physical.

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

As this is a mechanical device, the "ground truth" for its performance is established by:

Compliance with Industry Standards: E.g., ISO 14457 (Dentistry Handpieces and Motors), IEC 60601-1 (Medical Electrical Equipment), ANSI/AAMI ST79, ISO 14937, ANSI/AAMI ST81 (for sterilization), FDA Guidance for "Reprocessing Medical Devices."
Engineering Specifications: Meeting predefined rotational speed, power, and torque outputs.
Material Compatibility: Use of materials with established safety profiles (Stainless steel, PEEK, Ceramic bearings) from existing industry knowledge.

These standards and specifications serve as the "ground truth" against which the device's physical and functional performance is measured.

8. The sample size for the training set

Not applicable. This device does not use machine learning or AI, and therefore, there is no "training set."

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

Not applicable. As there is no training set, there is no ground truth for it to be established.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the agency's name, "U.S. Food & Drug Administration."

January 6, 2020

Robert Young Senior Director of Engineering 1816 Colonial Village Lane Lancaster, Pennsylvania 17601

Re: K192412

Trade/Device Name: SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece, SD500 Pro LubeFree High Speed Handpiece, Pro Lubricated High Speed Handpiece Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I. reserved Product Code: EFB Dated: October 3, 2019 Received: October 8, 2019

Dear Robert Young:

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.

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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,

for Srinivas "Nandu" Nandkumar, Ph.D. 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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K192412

Device Name

SD500 High Speed Handpiece Scries - SD500 Elite LubeFree Handpiece, SD500 Pro LubeFree Handpiece, SD500 Elite Lubricated Handpiece, SD500 Pro Lubricated Handpiece

Indications for Use (Describe)

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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Image /page/3/Picture/0 description: The image shows the logo for DentalEZ, Inc., StarDental Division. The logo features a circular design with overlapping arcs in shades of brown, gray, and green. To the right of the circular design is the text "DentalEZ" in a bold, dark brown font, with the words "INTEGRATED SOLUTIONS" in a smaller, light gray font underneath. Below the logo is the text "DentalEZ, Inc.," followed by "StarDental Division" on the next line.

510(K) Premarket Notification SD500 High Speed Handpiece Series

510(k) Summary

l. SUBMITTER

K192412

DentalEZ Inc., StarDental Division 1816 Colonial Village Lane Lancaster, PA 17601 Phone: (717) 291-1161 Contact Person: Robert Young, Senior Director of Engineering Kay Engle, Regulatory Affairs/QA Supervisor September 3, 2019

II. DEVICE

Name of the Device: SD500 High Speed Handpiece Series comprised of: SD500 Elite LubeFree High-Speed Handpiece SD500 Pro LubeFree High-Speed Handpiece SD500 Elite Lubricated High-Speed Handpiece SD500 Pro Lubricated High-Speed Handpiece Common or Usual name: High-Speed Handpiece Classification Name: Dental Handpieces and Accessories Regulation Number: 21 CFR 872.4200

Regulatory Class: I Product Code: EFB

III. PREDICATE DEVICE

Primary predicate: 430 Torque High Speed Handpiece Series (K153411) Reference device: Concentrix MX-AC High-Speed Handpiece (K173465)

IV. DEVICE DESCRIPTION:

The handpieces incorporate either a lubefree ceramic bearing turbine assembly or a lubricated ceramic bearing turbine assembly. Both versions of the turbine assembly use a push button autochuck. The stainless steel and aluminum air driven turbine assembly provides rotation to the bur.

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The SD500 High-Speed Handpiece Series uses a quick disconnect coupler that allows easy connection to the dental line delivery tubing. This coupler allows for easy rotation of the handpieces when attached to the tubing. These couplers include both fiber optic and nonfiber optic versions with Type 3 or 2 connections. The fiber optic version uses LED technology to deliver the light to the handpiece. All couplers are autoclavable.

The burs used with the SD500 High Speed Handpiece Series are ISO 1797-1, type 2 burs. Only burs with hardened, tempered steel shanks or carbide shanks should be used.

All handpieces in this series incorporate RFID (radio frequency identification) technology. This passive RFID tag does not have a built-in energy source. The RFID tag will allow the practitioner to track the device within the office only if the practitioner has a separate reader. A reader will enable the practitioner to track such things as usage and maintenance.

V. INDICATIONS FOR USE

The SD500 High Speed Handpiece Series are used by trained dental professionals for a variety of procedures including but not limited to caries and amalgam removal, restorative work and crown preparations

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE:

The SD500 High Speed Handpiece Series and the primary predicate device have the same technological characteristics:

Intended use
Method of operation
Use of the same base materials for the stainless steel components ●
Autoclavable

The following technological differences exist between the SD500 High Speed Handpiece Series and the predicate:

Multi-port spray
. RFID technology

The proposed SD500 High Speed Handpiece Series and the reference device have the same technological similarities and differences as noted above for the primary predicate. In addition, the reference device incorporates a lubricated turbine assembly in the handpiece. This lubricated turbine will be incorporated into the lubricated version of the proposed handpiece.

The difference between the proposed devices and the primary predicate device is the number of water spray ports, addition of RFID technology and the addition of PEEK (Polyether Ether Ketone) to the base materials. These differences do not affect the performance or safety of the device.

The following table summarizes the comparison of the proposed SD500 High Speed Handpiece Series to the primary predicate device and the reference device for use and technological characteristics.

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		Primary Predicate:	Reference Device:
		430 Torque High SpeedHandpiece Series	Concentrix MX-AC HighSpeed Handpiece(K173465)
Device	Proposed device:SD500 High SpeedHandpiece Series	comprised of: 430 SWLTorque High SpeedHandpiece and 430 SWTorque High SpeedHandpiece (K153411)
Indications forUse	The SD500 High SpeedHandpiece Series is usedby trained dentalprofessionals for a varietyof procedures includingbut not limited to cariesand amalgam removal,restorative work andcrown preparations	The 430 Torque High-SpeedHandpiece Series are usedby trained dentalprofessionals for a varietyof procedures including butnot limited to caries andamalgam removal,restorative work and crownpreparations	The Concentrix MX-ACHigh-Speed Handpiece isused by trained dentalprofessionals for a varietyof procedures including butnot limited to caries andamalgam removal,restorative work and crownpreparations.
Product Code	EFB	EFB	EFB
OperationalMode	Air driven	Air driven	Air Driven
Type of chuck	Autochuck	Autochuck	Autochuck
OperatingPressure	38-43 PSI	38-43 PSI	32 PSI
Coupling Type	ISO 9168, Type 3, Type 2	ISO 9168, Type 3	ISO 9168, Type 1
Bur Dimension	ISO 1797-1, Type 2	ISO 1797-1, Type 2	ISO 1797-1, Type 2
Materialcomposition	Stainless steelPEEK (Polyether EitherKetone)	Stainless steel	Stainless steel
Components	High speed pneumaticdriven handpiece withoption of lube-free orlubricated ceramicbearingsautochuck turbineassemblyPushbutton end capSwivel couplingRFID tag	High speed pneumaticdriven handpiece.Lubricated ceramicbearingsAutochuck turbineassemblyPushbutton end capSwivel coupling	High speed pneumaticdriven handpieceLubricated steel bearingautochuck turbineassembly.Pushbutton end capSwivel coupling
Biocompatibility	Stainless steelPEEKCeramic bearings	Stainless steelCeramic bearings	Stainless steelSteel bearings
	Ceramic bearings
Sterilization	Sterilization validation inaccordance withANSI/AAMI ST79:2010 &A4:2013, AAMI/ANSI/ISO14937:2009 & ANSI/AAMIST81-2004 (R2010)	Sterilization validation inaccordance withANSI/AAMI ST79:2010 &A4:2013, AAMI/ANSI/ISO14937:2009 and NSI/AAMIST81-2004 (R2010)	Sterilization validation inaccordance withANSI/AAMI ST79:2010 &A4:2013, AAMI/ANSI/ISO14937:2009 and NSI/AAMIST81-2004 (R2010)
Device	Proposed device:SD500 High SpeedHandpiece Series	Primary Predicate:430 Torque High SpeedHandpiece Seriescomprised of: 430 SWLTorque High SpeedHandpiece and 430 SWTorque High SpeedHandpiece (K153411)	Reference Device:Concentrix MX-AC HighSpeed Handpiece(K173465)
Performance	Capable of reachingrotational speed of367,200 to 448,800 at arecommended airpressure of 38 - 43 PSI;delivers a range of 39 - 50watts of power providing.28 oz.-in. of stall torque.Performance testing incompliance with ISO14457:2012 – Dentistry –Handpieces and Motors	Capable of reachingrotational speeds of360,000 to 450,000 rpms ata recommended airpressure of 38-43 PSI;delivers on average 20watts of power providing.269 oz .- in. of stall torque.Performance testing incompliance with ISO 14457:2012 Dentistry -Handpieces and Motors	Variable 302,000 rpm +/-10%Performance testing incompliance with ISO14457:2012 Dentistry –Handpieces and Motors
Risk analysis	ISO14971:2012 Medicaldevices – Application ofrisk management tomedical devices	ISO14971:2012 Medicaldevices – Application of riskmanagement to medicaldevices	ISO14971:2012 Medicaldevices - Application of riskmanagement to medicaldevices

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VII. PERFORMANCE DATA

The following tests were conducted to evaluate the functional performance and safety of the SD500 High Speed Handpiece Series:

ISO 14457: 2017 Dentistry Handpieces and Motors .
. IEC 60601-1:2005 Medical Electrical Equipment – Part 1: General requirements for basic safety and essential performance

The test results confirm that the SD500 High Speed Handpiece Series conform to the requirements of ISO 14457:2012 and IEC 60601-1:2005 and are substantially equivalent for use as high speed handpieces.

Biocompatibility testing was not conducted on the materials used in the SD500 High Speed Handpiece Series. The materials used in these handpieces are widely known and used within the dental and medical device industry.

Sterilization validation for the handpieces which incorporate the turbine assemblies was performed in accordance to ANSI/AAMI ST79:2010 & A4:2013, AAMI/ANSI/ISO 14937:2009 and ANSI/AAMI ST81:2004 (R2010). Cleaning and disinfection validation was conducted per the FDA Guidance Document for "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" issued on March 17, 2015.

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A risk analysis for the SD500 High Speed Handpiece was developed using ISO14971:2012.

VIII. CONCLUSION

Based upon the comparison of technological characteristics, demonstrated through bench testing and intended use, the SD500 High Speed Handpiece Series is as safe and effective as the predicate devices.

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.