(124 days)
No
The description details a mechanical dental handpiece with RFID for tracking, but no mention of AI/ML for analysis or control.
No
Explanation: While the device is used in medical procedures (dental), its function is mechanical (drilling, shaping) rather than directly therapeutic in the sense of treating a disease or disorder with a specific therapeutic mechanism (e.g., drug delivery, radiation therapy, electrical stimulation). It assists in preparing the site for restorative work, which is rehabilitative, but not therapeutic in its direct action.
No
The device is a high-speed handpiece used by dental professionals for procedures such as caries and amalgam removal, restorative work, and crown preparations, which are therapeutic and restorative procedures, not diagnostic ones.
No
The device description clearly details a physical, pneumatically driven handpiece constructed of stainless steel and PEEK, with internal components like turbines, bearings, and water/air tubes. While it incorporates RFID technology, this is a passive tag for tracking and does not constitute the primary function of the device as software. The device is fundamentally a piece of hardware used in dental procedures.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used for dental procedures like caries and amalgam removal, restorative work, and crown preparations. These are direct interventions on the patient's body.
- Device Description: The description details a mechanical, pneumatically driven handpiece used for physical manipulation of dental tissues.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or treatment.
IVD devices are specifically designed to perform tests on biological samples outside of the body to gain diagnostic information. This dental handpiece operates within the body for therapeutic and restorative purposes.
N/A
Intended Use / Indications for Use
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.
Product codes
EFB
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained dental professionals / dental office
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
A risk analysis for the SD500 High Speed Handpiece was developed using ISO14971:2012.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
1
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
2
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)
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.
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 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.
4
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 Speed | |||
| Handpiece Series | Concentrix MX-AC High | ||
| Speed Handpiece | |||
| (K173465) | |||
| Device | Proposed device: | ||
| SD500 High Speed | |||
| Handpiece Series | comprised of: 430 SWL | ||
| Torque High Speed | |||
| Handpiece and 430 SW | |||
| Torque High Speed | |||
| Handpiece (K153411) | |||
| Indications for | |||
| Use | 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 | The 430 Torque 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 | The Concentrix MX-AC | ||
| High-Speed Handpiece 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. | |||
| Product Code | EFB | EFB | EFB |
| Operational | |||
| Mode | Air driven | Air driven | Air Driven |
| Type of chuck | Autochuck | Autochuck | Autochuck |
| Operating | |||
| Pressure | 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 |
| Material | |||
| composition | Stainless steel | ||
| PEEK (Polyether Either | |||
| Ketone) | Stainless steel | Stainless steel | |
| Components | High speed pneumatic | ||
| driven handpiece with | |||
| option of lube-free or | |||
| lubricated ceramic | |||
| bearings | |||
| autochuck turbine | |||
| assembly | |||
| Pushbutton end cap | |||
| Swivel coupling | |||
| RFID tag | High speed pneumatic | ||
| driven handpiece. | |||
| Lubricated ceramic | |||
| bearings | |||
| Autochuck turbine | |||
| assembly | |||
| Pushbutton end cap | |||
| Swivel coupling | High speed pneumatic | ||
| driven handpiece | |||
| Lubricated steel bearing | |||
| autochuck turbine | |||
| assembly. | |||
| Pushbutton end cap | |||
| Swivel coupling | |||
| Biocompatibility | Stainless steel | ||
| PEEK | |||
| Ceramic bearings | Stainless steel | ||
| Ceramic bearings | Stainless steel | ||
| Steel bearings | |||
| Ceramic bearings | |||
| Sterilization | Sterilization validation in | ||
| accordance with | |||
| ANSI/AAMI ST79:2010 & | |||
| A4:2013, AAMI/ANSI/ISO | |||
| 14937:2009 & ANSI/AAMI | |||
| ST81-2004 (R2010) | Sterilization validation in | ||
| accordance with | |||
| ANSI/AAMI ST79:2010 & | |||
| A4:2013, AAMI/ANSI/ISO | |||
| 14937:2009 and NSI/AAMI | |||
| ST81-2004 (R2010) | Sterilization validation in | ||
| accordance with | |||
| ANSI/AAMI ST79:2010 & | |||
| A4:2013, AAMI/ANSI/ISO | |||
| 14937:2009 and NSI/AAMI | |||
| ST81-2004 (R2010) | |||
| Device | Proposed device: | ||
| SD500 High Speed | |||
| Handpiece Series | Primary Predicate: | ||
| 430 Torque High Speed | |||
| Handpiece Series | |||
| comprised of: 430 SWL | |||
| Torque High Speed | |||
| Handpiece and 430 SW | |||
| Torque High Speed | |||
| Handpiece (K153411) | Reference Device: | ||
| Concentrix MX-AC High | |||
| Speed Handpiece | |||
| (K173465) | |||
| Performance | Capable of reaching | ||
| rotational speed of | |||
| 367,200 to 448,800 at a | |||
| recommended air | |||
| pressure of 38 - 43 PSI; | |||
| delivers a range of 39 - 50 | |||
| watts of power providing | |||
| .28 oz.-in. of stall torque. | |||
| Performance testing in | |||
| compliance with ISO | |||
| 14457:2012 – Dentistry – | |||
| Handpieces and Motors | Capable of reaching | ||
| rotational speeds of | |||
| 360,000 to 450,000 rpms at | |||
| a recommended air | |||
| pressure of 38-43 PSI; | |||
| delivers on average 20 | |||
| watts of power providing | |||
| .269 oz .- in. of stall torque. | |||
| Performance testing in | |||
| compliance with ISO 14457: | |||
| 2012 Dentistry - | |||
| Handpieces and Motors | Variable 302,000 rpm +/- | ||
| 10% | |||
| Performance testing in | |||
| compliance with ISO | |||
| 14457:2012 Dentistry – | |||
| Handpieces and Motors | |||
| Risk analysis | ISO14971:2012 Medical | ||
| devices – Application of | |||
| risk management to | |||
| medical devices | ISO14971:2012 Medical | ||
| devices – Application of risk | |||
| management to medical | |||
| devices | ISO14971:2012 Medical | ||
| devices - Application of risk | |||
| management to medical | |||
| devices |
6
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.
7
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.