(240 days)
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
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.
The provided text is a 510(k) premarket notification for a medical device (DentalEZ, Inc., StarDental Division's Star E900 Handpiece Series). This document describes the device and its equivalence to legally marketed predicate devices, but it does not contain acceptance criteria or study results in the format you requested for AI/algorithm performance.
The document describes bench tests conducted to evaluate the functional performance and safety of the device against standards like ISO 14457:2017 and IEC 60601-1:2020. It also mentions biocompatibility testing leveraged from a reference device and sterilization/cleaning validation. However, these are evaluations of the physical medical device itself, not an AI or algorithm.
Therefore, I cannot fulfill your request to provide:
- A table of acceptance criteria and reported device performance (for an AI/algorithm).
- Sample size used for the test set and data provenance.
- Number of experts and their qualifications for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study results.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document is for a traditional dental handpiece, not a device that utilizes AI or an algorithm that would have "ground truth" or "training sets" in the context of your request.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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).
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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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
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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.
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DENTALE 7
DentalEZ, Inc., StarDental Division
l. SUBMITTER
DentalEZ Inc., StarDental Division 1816 Colonial Village Lane Lancaster, PA 17601 Phone: (717) 291-1161 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:
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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,
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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 SpeedHandpieces (K192412) | |
| Indications forUse | This medical device is:- Intended to be usedfor general dentistryby trained dentalprofessionals- Intended for thefollowingapplications:The removal of decayedmatter, cavity andcrown preparations, theremoval of fillings andsurface finishing oftooth and restorationsurfaces. | This medical device is:- Intended fordental treatmentsonly- Suggested for thefollowingapplications:The removal ofdecayed matter, cavityand crownpreparations, theremoval of fillings andsurface finishing oftooth and restorationsurfaces. | The SD500 High SpeedHandpiece Series isused by trained dentalprofessionals for avariety of proceduresincluding but notlimited to caries andamalgam removal,restorative work andcrown preparations |
| Design | Contra-angle | Contra-angle | NA |
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| Ratio | 1:5 | 1:5 | NA |
|---|---|---|---|
| Identification | Red ring | Red dot | NA |
| Operational Mode | Electric micro-motor orair driven | Electric micro-motor orair driven | Air driven |
| Type of chuck | Pushbutton autochuck | Pushbutton | Autochuck |
| OperatingPressure | 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 glassrod | Yes - fiber optic glassrod | Yes – fiber optic glassrod |
| 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 |
| Maximumrotation speed | 200,000 rpm | 200,000 rpm | 408,000 rpm |
| Materialcomposition | Stainless steelPEEK | Stainless steel coveredwith Chrome, PEEK | Stainless steelPEEK |
| Lubricant | Electric HandpieceLubricant (K163483) | StatCare (K062418) | NA |
| Sterility | Not supplied sterile –can be autoclaved | Not supplied sterile –can be autoclaved | Not supplied sterile –can be autoclaved |
| RFID technology | Yes - passive | No | Yes - passive |
| Thermal sensor | Yes - service use only | No | No |
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| Device | Proposed device: | Predicate: | Reference Predicate: |
|---|---|---|---|
| Star E900 1:1 Handpiece | SANAO 40L (K132356) | SD500 High SpeedHandpieces (K192412) | |
| Indications forUse | This medical device is:- Intended to be usedfor general dentistryby trained dentalprofessionals- Intended for thefollowingapplications:Cavity preparation,caries excavation,endodonticsapplications, processingof tooth and restorationsurfaces | This medical device is:- Intended fordental treatmentsonly- Suggested for thefollowingapplications:Preparation ofcavities, cariesexcavation,endodonticapplications,processing of toothand restorationsurfaces | The SD500 High SpeedHandpiece Series isused by trained dentalprofessionals for avariety of proceduresincluding but notlimited to caries andamalgam removal,restorative work andcrown preparations |
| Design | Contra-angle | Contra-angle | NA |
| Ratio | 1:1 | 1:1 | NA |
| Identification | Blue ring | Blue dot | NA |
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| Device | Proposed device: | Predicate: | Reference Predicate: |
|---|---|---|---|
| Operational Mode | Electric micro-motor orair driven | Electric micro-motor orair driven | Air driven |
| Type of chuck | Pushbutton auto latch | Pushbutton auto latch | Autochuck |
| OperatingPressure | 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 glassrod | Yes - fiber optic glassrod | Yes - fiber optic glassrod |
| 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 |
| Maximumrotation 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 HandpieceLubricant (K163483) | StatCare (K062418) | NA |
| Sterility | Not supplied sterile -can be autoclaved | Not supplied sterile -can be autoclaved | Not supplied sterile -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 SpeedHandpieces (K192412) | |
| Indications forUse | This medical device is:- Intended to be usedfor general dentistryby trained dentalprofessionals- Intended for thefollowingapplications:Cavity preparation,caries excavation,endodonticsapplications, processingof tooth and restorationsurfaces | This medical device is:- Intended fordental treatmentsonly- Suggested for thefollowingapplications:Preparation ofcavities, cariesexcavation,endodonticapplications,processing of toothand restorationsurfaces | The SD500 High SpeedHandpiece Series isused by trained dentalprofessionals for avariety of proceduresincluding but notlimited to caries andamalgam removal,restorative work andcrown preparations |
| Design | Contra-angle | Contra-angle | NA |
| Ratio | 5:1 | 5:1 | NA |
| Identification | Green ring | Green dot | NA |
| Operational Mode | Electric micro-motor orair driven | Electric micro-motor orair driven | Air driven |
| Type of chuck | Pushbutton auto latch | Pushbutton auto latch | Autochuck |
| OperatingPressure | 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 glassrod | Yes - fiber optic glassrod | Yes - fiber optic glassrod |
| 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 |
| Maximumrotation speed | 8,000 rpm | 8,000 rpm | 408,000 rpm |
| Materialcomposition | Stainless steelPEEK | Stainless steel coveredwith Chrome, PEEK | Stainless steelPEEK |
| Lubricant | Electric Handpiecelubricant (K163483) | StatCare (K062418) | NA |
| Sterility | Not supplied sterile -can be autoclaved | Not supplied sterile -can be autoclaved | Not supplied sterile -can be autoclaved |
| RFID Technology | Yes - passive | No | Yes - passive |
| Thermal sensor | Yes - service use only | No | No |
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| Device | Proposed device: | Predicate: | Reference Predicate |
|---|---|---|---|
| Star E900 1:1 StraightHandpiece | SANAO 40 ST (K132356) | SANAO PSO (K132356) | |
| Indications forUse | This medical device is:- Intended to be- used for generaldentistry by traineddental professionals- Intended for thefollowingapplications:Prophylaxis treatment,crown preparation,polishing, finishing oftooth and restorationsurfaces | This medical device is:- Intended fordental treatmentsonly- Suggested for thefollowingapplications:Removal of cariousmaterial, cavities andcrown preparations,removal of fillings,processing of toothand restorationsurfaces | This medical device is:- Only intended fordental treatment- Suggested for thefollowingapplication: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 orair driven | Electric micro-motor orair driven | Electric micro-motor orair driven |
| Type of chuck | Manual chuck | Manual chuck | NA |
| OperatingPressure | 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-functionISO 13295, Type 5 |
| Max drive speed | 40,000 rpm | 40,000 rpm | 8,000 rpm |
| Maximumrotation speed | 40,000 rpm | 40,000 rpm | 40,000 rpm |
| Materialcomposition | Stainless steelPEEK | Stainless steel coveredwith Chrome, PEEK | Stainless steel coveredwith Chrome |
| Lubricant | Electric HandpieceLubricant (K163483) | StatCare (K062418) | StatCare (K062418) |
| Sterility | Not supplied sterile -can be autoclaved. | Not supplied sterile -can be autoclaved. | Not supplied sterile -can be autoclaved. |
| RFID | Yes — passive | No | No |
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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 currently on the market.
IX. CONCLUSION
The Indications for Use of the Star E900 Handpiece Series is substantially equivalent to the predicate devices as are the principles of operation and design features. The minor differences in the characteristics between the Star E900 Handpiece Series and predicate as indicated in the comparison charts do not affect the performance or Indications for Use of the proposed devices.
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Based upon the comparison of technological characteristics, demonstrated through bench testing and intended use, the Star E900 Handpiece Series is substantially equivalent to the predicate devices.
§ 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.