Star E900 Handpiece Series

K240183 · Dentalez, Inc., Stardental Division · EGS · Sep 19, 2024 · Dental

Device Facts

• Record ID: K240183
• Device Name: Star E900 Handpiece Series
• Applicant: Dentalez, Inc., Stardental Division
• Product Code: EGS · Dental
• Decision Date: Sep 19, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Star E900 Handpiece Series are intended to be used for general dentistry by trained dental professionals. The intended use of the respective handpieces is dependent on the gear ratio. Star E900 1:5 Handpiece: the removal of decayed matter, cavity and crown preparations, the removal of fillings and surface finishing of tooth and restoration surfaces. Star E900 1:1 Handpiece: Cavity preparations, caries excavation, endodontic applications, processing of tooth and restoration surfaces. Star E900 5:1 Handpiece: Cavity preparations, caries excavation, endodontic applications, processing of tooth and restoration surfaces. Star E900 1:1 Straight Handpiece: prophylaxis treatment, crown preparations, polishing of tooth and restoration surfaces

Device Story

Reusable contra-angle and straight dental handpieces; driven by ISO 3964 compliant electric micro-motor or air-driven motor. Inputs: mechanical energy from motor; outputs: rotational power to dental burs for tooth/restoration processing. Features: fiberoptic illumination, multi-port water spray (except straight model), passive RFID tag for tracking usage/maintenance via external reader, and internal temperature sensor for service-only mechanical failure detection. Used in dental clinics by trained professionals. Output affects clinical decision-making by enabling precise tooth structure removal and restoration finishing. Benefits: ergonomic design, illumination, and integrated tracking/monitoring for maintenance.

Clinical Evidence

Bench testing only. Evaluated per ISO 14457:2017 and IEC 60601-1:2020. Biocompatibility assessment leveraged from reference device K192412. Sterilization, cleaning, and disinfection validated per AAMI/ISO standards and FDA guidance. Risk management conducted per ISO 14971:2012.

Technological Characteristics

Materials: stainless steel, PEEK. Energy: electric micro-motor or air-driven motor. Connectivity: passive RFID tag. Sensing: internal temperature sensor (service use only). Illumination: fiberoptic glass rod. Sterilization: autoclavable. Standards: ISO 3964 (coupling), ISO 1797 (burs), ISO 14457, IEC 60601-1.

Indications for Use

Indicated for trained dental professionals performing general dentistry, including cavity/crown preparation, caries excavation, endodontic applications, prophylaxis, polishing, and removal of decayed matter/fillings.

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

• Sanao Dental Handpiece (K132356)

Reference Devices

• SD500 High Speed Handpiece Series (K192412)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 19, 2024

DentalEZ, Inc., StarDental Division Kay Engle Regulatory Affairs Manager 1816 Colonial Village Lane Lancaster, Pennsylvania 17601

Re: K240183

Trade/Device Name: Star E900 Handpiece Series Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I, reserved Product Code: EGS Dated: August 21, 2024 Received: August 21, 2024

Dear Kay Engle:

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.

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).

{1}------------------------------------------------

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

{2}------------------------------------------------

Sincerely,

Bobak Shirmohammadi -S

For Michael E. Adjodha, M.ChE., RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

# K240183

Device Name

# Star E900 Handpiece Series

#### Indications for Use (Describe)

The Star E900 Handpiece Series are intended to be used for general dentistry by trained dental professionals. The intended use of the respective handpieces is dependent on the gear ratio.

Star E900 1:5 Handpiece: the removal of decayed matter, cavity and crown preparations, the removal of fillings and surface finishing of tooth and restoration surfaces.

Star E900 1:1 Handpiece: Cavity preparations, caries excavation, endodontic applications, processing of tooth and restoration surfaces.

Star E900 5:1 Handpiece: Cavity preparations, caries excavation, endodontic applications, processing of tooth and restoration surfaces.

Star E900 1:1 Straight Handpiece: prophylaxis treatment, crown preparations, polishing of tooth and restoration surfaces

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

> Prescription Use (Part 21 CFR 801 Subpart D)

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

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

# DENTALE 7

DentalEZ, Inc., StarDental Division

#### l. SUBMITTER

DentalEZ Inc., StarDental Division 1816 Colonial Village Lane Lancaster, PA 17601 Phone: [phone] Contact Person: Robert Young, Vice President of Research and Development Kay Engle, Regulatory Affairs Manager September 17, 2024

# II. DEVICE

Trade Name: Star E900 Handpiece Series Common Name: Handpiece, Contra- and Right-Angle Attachment, Dental Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: Class I Product Code: EGS

# III. PREDICATE DEVICE

| Clearance: | K132356 dated January 31, 2014 |
|--------------------|-------------------------------------------------------|
| Manufacturer: | SciCan GmbH |
| Trade/Device Name: | Sanao Dental Handpiece |
| Common Name: | Handpiece, Contra- and Right-Angle Attachment, Dental |
| Regulation Number: | 21CFR 872.4200 |
| Regulation Name: | Dental Handpiece and Accessories |
| Regulation Class: | Class I |
| Product Code: | EGS |

# IV. REFERENCE DEVICE

Clearance: K192412 dated January 6, 2020 Manufacturer: DentalEZ, Inc., StarDental Division Trade/Device Name: SD500 High Speed Handpiece Series Common Name: High Speed Handpiece Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpieces and Accessories Regulation Class: Class I EFB Product Code:

{5}------------------------------------------------

# V. DEVICE DESCRIPTION:

The Star E900 Handpiece Series are reusable contra-angle handpieces, driven by an ISO 3964 compliant electric micro-motor or air driven motor, that are intended for use by trained dental professionals in the field of general dentistry. The Star E900 1:5, 1:1 and 5:1 handpieces are designed for general applications to prepare dental cavities for restoration. The Star E900 1:1 Straight Handpiece is designed for prophylaxis treatment, crown preparations, polishing finishing of tooth and restoration surfaces.

The Star E900 Handpiece Series feature an ISO 3964 compliant handpiece coupling connecting them to an electric micro-motor controlled by an electric control unit or air driven motor connected to a dental delivery unit. The control unit or delivery unit supplies energy to the handpiece which powers the gears within the handpieces. Depending on the applications, the handpieces have a maximum drive speed of 8,000 to 200,000 RPM's.

These handpieces are ergonomically shaped and have glass rod fiberoptics to illuminate the oral cavity during procedures. In addition, the handpieces have multi-port water spray. The exception to the fiber optics and water spray features is the Star E900 1:1 Straight Handpiece. This handpiece does not contain any fiberoptics nor does it have water spray capabilities.

All the handpieces in the Star E900 Handpiece series are composed of stainless steel and PEEK. They can be autoclaved.

The Star E900 Handpieces use only burs with hardened, tempered steel shanks or carbide shanks which are ISO 1797 compliant.

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. The RFID reader will enable the practitioner to track such things as usage and maintenance.

The handpieces, with the exception of the Star E900 1:1 Straight Handpiece, incorporate a temperature sensor to be used in the service of the device, by trained service personnel, to access excessive heat in the handpiece, indicative of mechanical failure. This feature is not accessible to the practitioner.

#### VI. INDICATIONS FOR USE

Star E900 Handpiece Series are intended to be used for general dentistry work by a trained dental professional. The intended use of the respective handpieces is dependent on the gear ratio.

Star E900 1:5 Handpiece: the removal of decayed matter, cavity and crown preparations, the removal of fillings and surface finishing of tooth and restoration surfaces.

Star E900 1:1 Handpiece : Cavity preparations, caries excavation, endodontic applications, processing of tooth and restoration surfaces.

Star E900 5:1 Handpiece: Cavity preparations, caries excavation, endodontic applications,

{6}------------------------------------------------

processing of tooth and restoration surfaces.

Star E900 1:1 Straight Handpiece: prophylaxis treatment, crown preparations, polishing, finishing of tooth and restoration surfaces

# VII. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS:

The Star E900 Handpiece Series, the predicate device and the reference predicate devices have the same technological characteristics:

- Intended use
- Power source
- . Use of the same base materials
- Autoclavable ●
- . RFID technology

The following technological difference exist between the Star E900 Handpiece Series and the predicate devices:

- . Temperature sensor
The Star E900 Handpiece Series are similar in design, function and intended use to other dental handpieces currently distributed in the U.S.

The technological differences noted do not affect the performance of the device.

The following tables summarize the comparison between the different Star E900 Handpiece in the series to the predicate devices.

| Device | Proposed device: | Predicate: | Reference Predicate: |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Star E900 1:5 Handpiece | SANAO 200L (K132356) | SD500 High Speed<br>Handpieces (K192412) |
| Indications for<br>Use | This medical device is:<br>- Intended to be used<br>for general dentistry<br>by trained dental<br>professionals<br>- Intended for the<br>following<br>applications:<br>The removal of decayed<br>matter, cavity and<br>crown preparations, the<br>removal of fillings and<br>surface finishing of<br>tooth and restoration<br>surfaces. | This medical device is:<br>- Intended for<br>dental treatments<br>only<br>- Suggested for the<br>following<br>applications:<br>The removal of<br>decayed matter, cavity<br>and crown<br>preparations, the<br>removal of fillings and<br>surface finishing of<br>tooth and restoration<br>surfaces. | The SD500 High Speed<br>Handpiece Series is<br>used by trained dental<br>professionals for a<br>variety of procedures<br>including but not<br>limited to caries and<br>amalgam removal,<br>restorative work and<br>crown preparations |
| Design | Contra-angle | Contra-angle | NA |

{7}------------------------------------------------

| Ratio | 1:5 | 1:5 | NA |
|-----------------------|---------------------------------------|---------------------------------------|------------------------|
| Identification | Red ring | Red dot | NA |
| Operational Mode | Electric micro-motor or<br>air driven | Electric micro-motor or<br>air driven | Air driven |
| Type of chuck | Pushbutton autochuck | Pushbutton | Autochuck |
| Operating<br>Pressure | 36-72 PSI | 39.2 PSI | 38-43 PSI |
| Coupling Type | ISO 3964, Type 3, short | ISO 3964 | ISO 9168,Type 3,Type 2 |

| Device | Proposed device: | Predicate: | Reference Predicate: |
|---------------------------|---------------------------------------------|----------------------------------------------|---------------------------------------------|
| Air/water ports | 3 ports | 3 ports | 3 ports |
| Cooling | Water/air | Water/air | Water/air |
| Spray | Yes | Yes | Yes |
| Light | Yes - fiber optic glass<br>rod | Yes - fiber optic glass<br>rod | Yes – fiber optic glass<br>rod |
| Bur Dimension | ISO 1797, Type 3 | ISO 1797, Type 3 | ISO 1797-1, Type 2 |
| Max drive speed | 40,000 rpm | 40,000 rpm | NA |
| Maximum<br>rotation speed | 200,000 rpm | 200,000 rpm | 408,000 rpm |
| Material<br>composition | Stainless steel<br>PEEK | Stainless steel covered<br>with Chrome, PEEK | Stainless steel<br>PEEK |
| Lubricant | Electric Handpiece<br>Lubricant (K163483) | StatCare (K062418) | NA |
| Sterility | Not supplied sterile –<br>can be autoclaved | Not supplied sterile –<br>can be autoclaved | Not supplied sterile –<br>can be autoclaved |
| RFID technology | Yes - passive | No | Yes - passive |
| Thermal sensor | Yes - service use only | No | No |

{8}------------------------------------------------

| Device | Proposed device: | Predicate: | Reference Predicate: |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Star E900 1:1 Handpiece | SANAO 40L (K132356) | SD500 High Speed<br>Handpieces (K192412) |
| Indications for<br>Use | This medical device is:<br>- Intended to be used<br>for general dentistry<br>by trained dental<br>professionals<br>- Intended for the<br>following<br>applications:<br>Cavity preparation,<br>caries excavation,<br>endodontics<br>applications, processing<br>of tooth and restoration<br>surfaces | This medical device is:<br>- Intended for<br>dental treatments<br>only<br>- Suggested for the<br>following<br>applications:<br>Preparation of<br>cavities, caries<br>excavation,<br>endodontic<br>applications,<br>processing of tooth<br>and restoration<br>surfaces | The SD500 High Speed<br>Handpiece Series is<br>used by trained dental<br>professionals for a<br>variety of procedures<br>including but not<br>limited to caries and<br>amalgam removal,<br>restorative work and<br>crown preparations |
| Design | Contra-angle | Contra-angle | NA |
| Ratio | 1:1 | 1:1 | NA |
| Identification | Blue ring | Blue dot | NA |

{9}------------------------------------------------

| Device | Proposed device: | Predicate: | Reference Predicate: |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Operational Mode | Electric micro-motor or<br>air driven | Electric micro-motor or<br>air driven | Air driven |
| Type of chuck | Pushbutton auto latch | Pushbutton auto latch | Autochuck |
| Operating<br>Pressure | 36-72 PSI | 39.2 PSI | 38-43 PSI |
| Coupling Type | ISO 3964, Type 3, short | ISO 3964 | ISO 9168,Type 3,Type 2 |
| Cooling | Water/air | Water/air | 3 ports |
| Air/water ports | 3 ports | 1 port | Water/air |
| Spray | Yes | Yes | Yes |
| Light | Yes – fiber optic glass<br>rod | Yes - fiber optic glass<br>rod | Yes - fiber optic glass<br>rod |
| Bur dimension | ISO 1797, Type 1 | ISO 1797, Type 1 | ISO 1797-1, Type 2 |
| Max drive speed | 40,000 rpm | 40,000 rpm | NA |
| Maximum<br>rotation speed | 40,000 rpm | 40,000 rpm | 408,000 rpm |
| Material | Stainless steel | Stainless steel covered | Stainless steel |
| composition | PEEK | with Chrome, PEEK | PEEK |
| Lubricant | Electric Handpiece<br>Lubricant (K163483) | StatCare (K062418) | NA |
| Sterility | Not supplied sterile -<br>can be autoclaved | Not supplied sterile -<br>can be autoclaved | Not supplied sterile -<br>can be autoclaved |
| RFID | Yes - passive | No | Yes - passive |
| Thermal sensor | Yes - service use only | No | No |
| Device | Proposed device: | Predicate: | Reference Predicate: |
| | Star E900 5:1 Handpiece | SANAO 10L (K132356) | SD500 High Speed<br>Handpieces (K192412) |
| Indications for<br>Use | This medical device is:<br>- Intended to be used<br>for general dentistry<br>by trained dental<br>professionals<br>- Intended for the<br>following<br>applications:<br>Cavity preparation,<br>caries excavation,<br>endodontics<br>applications, processing<br>of tooth and restoration<br>surfaces | This medical device is:<br>- Intended for<br>dental treatments<br>only<br>- Suggested for the<br>following<br>applications:<br>Preparation of<br>cavities, caries<br>excavation,<br>endodontic<br>applications,<br>processing of tooth<br>and restoration<br>surfaces | The SD500 High Speed<br>Handpiece Series is<br>used by trained dental<br>professionals for a<br>variety of procedures<br>including but not<br>limited to caries and<br>amalgam removal,<br>restorative work and<br>crown preparations |
| Design | Contra-angle | Contra-angle | NA |
| Ratio | 5:1 | 5:1 | NA |
| Identification | Green ring | Green dot | NA |
| Operational Mode | Electric micro-motor or<br>air driven | Electric micro-motor or<br>air driven | Air driven |
| Type of chuck | Pushbutton auto latch | Pushbutton auto latch | Autochuck |
| Operating<br>Pressure | 36-72 PSI | 39.2 PSI | 38-43 PSI |
| Coupling Type | ISO 3964 Type 3, short | ISO 3964 | ISO 9168,Type 3,Type 2 |
| Air/water ports | 3 ports | 1 port | 3 ports |
| Cooling | Water/air | Water/air | Water/air |
| Spray | Yes | Yes | Yes |
| Light | Yes - fiber optic glass<br>rod | Yes - fiber optic glass<br>rod | Yes - fiber optic glass<br>rod |
| Bur Dimension | ISO 1797, Type 1 | ISO 1797, Type 1 | ISO 1797-1, Type 2 |
| Max drive speed | 40,000 rpm | 40,000 rpm | NA |
| Maximum<br>rotation speed | 8,000 rpm | 8,000 rpm | 408,000 rpm |
| Material<br>composition | Stainless steel<br>PEEK | Stainless steel covered<br>with Chrome, PEEK | Stainless steel<br>PEEK |
| Lubricant | Electric Handpiece<br>lubricant (K163483) | StatCare (K062418) | NA |
| Sterility | Not supplied sterile -<br>can be autoclaved | Not supplied sterile -<br>can be autoclaved | Not supplied sterile -<br>can be autoclaved |
| RFID Technology | Yes - passive | No | Yes - passive |
| Thermal sensor | Yes - service use only | No | No |

{10}------------------------------------------------

{11}------------------------------------------------

| Device | Proposed device: | Predicate: | Reference Predicate |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| | Star E900 1:1 Straight<br>Handpiece | SANAO 40 ST (K132356) | SANAO PSO (K132356) |
| Indications for<br>Use | This medical device is:<br>- Intended to be<br>- used for general<br>dentistry by trained<br>dental professionals<br>- Intended for the<br>following<br>applications:<br>Prophylaxis treatment,<br>crown preparation,<br>polishing, finishing of<br>tooth and restoration<br>surfaces | This medical device is:<br>- Intended for<br>dental treatments<br>only<br>- Suggested for the<br>following<br>applications:<br>Removal of carious<br>material, cavities and<br>crown preparations,<br>removal of fillings,<br>processing of tooth<br>and restoration<br>surfaces | This medical device is:<br>- Only intended for<br>dental treatment<br>- Suggested for the<br>following<br>application:<br>Prophylaxis treatment |
| Design | Straight Handpiece | Straight Handpiece | Contra-Angle |
| Ratio | 1:1 | 1:1 | 5:1 |
| Identification | Blue ring | Blue dot | Green dot |
| Operational Mode | Electric micro-motor or<br>air driven | Electric micro-motor or<br>air driven | Electric micro-motor or<br>air driven |
| Type of chuck | Manual chuck | Manual chuck | NA |
| Operating<br>Pressure | 36-72 PSI | 39.2 PSI | NA |
| Coupling Type | ISO 3964, Type 1, short | ISO 3964 | ISO 3964 |
| Air/water ports | None | 1 port | None |
| Cooling | None | Water/air | None |
| Spray | None | Yes | None |
| Light | No | No | No |
| Bur Dimension | ISO 1797, Type 2 | ISO 1797, Type 2 | Mandrels with snap-on-<br>function<br>ISO 13295, Type 5 |
| Max drive speed | 40,000 rpm | 40,000 rpm | 8,000 rpm |
| Maximum<br>rotation speed | 40,000 rpm | 40,000 rpm | 40,000 rpm |
| Material<br>composition | Stainless steel<br>PEEK | Stainless steel covered<br>with Chrome, PEEK | Stainless steel covered<br>with Chrome |
| Lubricant | Electric Handpiece<br>Lubricant (K163483) | StatCare (K062418) | StatCare (K062418) |
| Sterility | Not supplied sterile -<br>can be autoclaved. | Not supplied sterile -<br>can be autoclaved. | Not supplied sterile -<br>can be autoclaved. |
| RFID | Yes — passive | No | No |

{12}------------------------------------------------

#### VIII. PERFORMANCE DATA

The bench tests per the following standards were conducted to evaluate the functional performance and safety of the Star E900 Handpiece Series:

- ISO 14457: 2017 Dentistry - Handpieces and Motors
- IEC 60601-1: 2020, Consolidated Version: Medical Electrical Equipment Part 1: General ● requirements for basic safety and essential performance

The results of the bench testing verify that the Star E900 Handpiece Series conform to the requirements of ISO 14457:2012 and IEC 60601-1:2020 and demonstrate substantial equivalence to the predicate devices

Biocompatibility testing was not conducted on the materials used in the Star E900 Handpiece Series. However, an assessment as conducted per the FDA guidance "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process." The materials used in the subject device are identical to those used in the reference device, K192412, where biocompatibility testing was conducted and leveraged from.

Sterilization validation for the handpieces 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.

A risk management plan to identify any risks and the management of those risks was carried out during the design and development of the handpiece series. A risk analysis for the Star E900 Handpiece Series was conducted in accordance with ISO14971:2012. The analysis showed that the level of risk associated with the Star E900 Handpiece Series is not any greater than the level of risk associated with similar medical devices cu…