(135 days)
No
The device description focuses on mechanical and optical components and does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" field is also marked as "Not Found".
No
The device is a high-speed dental handpiece used for mechanical procedures like caries removal and crown preparation, not for treating a disease or condition as a therapeutic device would.
No
This device is a high-speed handpiece used by dental professionals for procedures like caries and amalgam removal, restorative work, and crown preparation, which are therapeutic and restorative, not diagnostic.
No
The device description clearly details a physical, pneumatically driven hand-held device constructed of stainless steel and aluminum, containing internal air and water tubes, a turbine assembly, bearings, and a push button autochuck. It also mentions fiber optics in one version. These are all hardware components, not software.
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 by trained dental professionals for procedures within the oral cavity (caries and amalgam removal, restorative work, crown preparation). These are direct interventions on a patient.
- Device Description: The description details a mechanical, pneumatically driven handpiece used for cutting and shaping dental materials. It does not describe any components or functions related to testing samples in vitro (outside of the living body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process that would fall under the definition of an in vitro diagnostic device.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This dental handpiece does not perform any such function.
N/A
Intended Use / Indications for Use
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.
Product codes
EFB
Device Description
The 430 Torque High-Speed Handpiece Series consists of a fiber optic high speed handpiece, marketed as a SWL and a non-fiber optic handpiece, marketed as a SW handpiece. Each is a pneumatically driven hand- held device that is capable of reaching rotational speeds of 350,000 to 450,000 rpms at a recommended air pressure of 38-43 PSI. The series delivers on average up to 20 watts of power providing .269 oz.-in. of stall torque.
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 stainless steel and aluminum air driven turbine assembly provides spin to the bur, and incorporates lubefree ceramic bearings (K905155) and a push button autochuck. The rotor is larger than the rotor of the predicate, yielding a higher cutting torque.
The fiber optics in the SWL version of the handpiece are lead-free, multi-core glass rod that transmit light from the fiber optic swivel coupler to the oral cavity.
The 430 Torque High-Speed handpiece Series can be assembled to quick disconnect couplers that are ISO Type 3 and ISO Type 2 connections, available as fiber optic or non-fiber optic versions, using a halogen bulb or LED technology. All couplers are autoclavable with the exception of the LED coupler that incorporates the electronics internally.
The following describes the improvements that have been made to the 430 Series High-Speed Handpiece and 430 SW Non-Fiber Optic Handpieces since the last 510(k) clearances, which have also been incorporated into the 430 Torque High-Speed Handpiece Series:
- The fiber-optics used in the SWL version of the handpieces changed from bundled fiber optics to twin-fused solid rod fiber optics.
- The finish of the outer housings on the handpieces has been modified to have a dull appearance (satin) through a process called bead blasting. This is an aesthetic change only and does not affect the performance of the handpiece. The finish of the outer housing on the handpieces continues to be available in the glossy finish as cleared on the predicate devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained dental professionals
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was completed in accordance with ISO 14457:2012 Dentistry – Handpieces and motors.
Sterilization validation for the sterilization of the handpieces was performed in accordance to ANSI/AAMI ST79:2010 & A4:2013, AAMI/ANSI/ISO 14937:2009 and ANSI/AAMI ST81:2004 (R2010).
A risk analysis for the 430 Torque High-Speed Handpiece Series was developed using ISO14971:2012.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol consists of three stylized human profiles facing right, with a stylized caduceus-like design wrapping around them. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 4,2016
Dentalez, Inc. Mr. Dan Laskowitz Engineering/Quality Manager 1816 Colonial Village Lane Lancaster, Pennsylvania 17601
Re: K153411
Trade/Device Name: 430 Torque High-speed Handpiece Series Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: Class I Product Code: EFB Dated: March 7, 2016 Received: March 8, 2016
Dear Mr. Lashkowitz:
This letter corrects our substantially equivalent letter of April 8, 2016.
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 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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal 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
1
Page 2
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Image /page/1/Picture/8 description: The image shows a signature that reads "Susan Runno DDS, MA". The signature is written in a cursive style with thick, black ink. The letters are connected, and the overall appearance is that of a handwritten name and credentials.
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K153411
Device Name
430 Torque High Speed Handpiece Series - 430 SWL Torque High Speed Handpiece, 430 SW Torque High Speed Handpiece
Indications for Use (Describe)
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 preparation.
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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
430 Torque High-Speed Handpiece Series
l. SUBMITTER
DentalEZ Inc., StarDental Division 1816 Colonial Village Lane Lancaster, PA 17601 Phone: (717) 291-1161 Fax: (717) 391-2757 Contact Person: Dan Laskowitz, Engineering/Quality Manager Kay Engle, Regulatory Affairs Supervisor/QA Date prepared: March 7, 2016
II. DEVICE
Name of Device: 430 Torque High Speed Handpiece Series comprised of: 430 SWL Torque High Speed Handpiece 430 SW Torque High Speed Handpiece Common or Usual Name: High Speed Handpiece Classification Name: Handpiece, Air-powered, Dental (21 C.F.R. § 872.4200) Regulatory Class: I Product Code: EFB
III. PREDICATE DEVICE:
Primary predicate: 430 SW Non-Fiber Optic Handpiece (K902402) Reference predicate: 430 Series High Speed Handpiece (K982593 and K960719)
IV. DEVICE DESCRIPTION:
The 430 Torque High-Speed Handpiece Series consists of a fiber optic high speed handpiece, marketed as a SWL and a non-fiber optic handpiece, marketed as a SW handpiece. Each is a pneumatically driven hand- held device that is capable of reaching rotational speeds of 350,000 to 450,000 rpms at a recommended air pressure of 38-43 PSI. The series delivers on average up to 20 watts of power providing .269 oz.-in. of stall torque.
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 stainless steel and aluminum air driven turbine assembly provides spin to the bur, and incorporates lubefree ceramic bearings (K905155) and a push button autochuck. The rotor is larger than the rotor of the predicate, yielding a higher cutting torque.
The fiber optics in the SWL version of the handpiece are lead-free, multi-core glass rod that transmit light from the fiber optic swivel coupler to the oral cavity.
4
The 430 Torque High-Speed handpiece Series can be assembled to quick disconnect couplers that are ISO Type 3 and ISO Type 2 connections, available as fiber optic or non-fiber optic versions, using a halogen bulb or LED technology. All couplers are autoclavable with the exception of the LED coupler that incorporates the electronics internally.
The following describes the improvements that have been made to the 430 Series High-Speed Handpiece and 430 SW Non-Fiber Optic Handpieces since the last 510(k) clearances, which have also been incorporated into the 430 Torque High-Speed Handpiece Series:
-
- The fiber-optics used in the SWL version of the handpieces changed from bundled fiber optics to twin-fused solid rod fiber optics.
-
- The finish of the outer housings on the handpieces has been modified to have a dull appearance (satin) through a process called bead blasting. This is an aesthetic change only and does not affect the performance of the handpiece. The finish of the outer housing on the handpieces continues to be available in the glossy finish as cleared on the predicate devices.
V. INDICATIONS FOR USE:
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.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE:
The 430 Torque High-Speed Handpieces and the primary predicate device are both air-driven handpieces used to perform a variety of dental procedures. The proposed devices and the primary predicate device have the same technological characteristics:
- Single water spray without cooling air
- Push button autochuck turbine assembly
- Bur extraction force ●
- Use of the same materials ●
- No lubrication required ●
- Autoclavable
- Connect to coupler allow for ease of rotation on tubing ●
The following technological differences exist between the 430 Torque High-Speed Handpiece and the primary predicate:
- . Free run speed (handpiece speed in RPM with no load applied)
- Power .
- Stall torque ●
5
The proposed 430 SWL Torque High-Speed Handpiece and the reference predicate device have the same technological similarities and differences as noted above for the primary predicate. In addition, the reference predicate incorporates fiber optics for illumination of the work area. The fiber optics used in the reference predicate device are incorporated in the proposed 430 SWL Torque High-Speed Handpiece.
The following table summarizes the comparison of the 430 Torque High-Speed Handpieces Series to the primary predicate device and reference predicate for indications for use and technological characteristics.
| Indications for use and technological characteristics. | |||
|---|---|---|---|
| Device | Submission device | ||
| K153411 430 Torque High | |||
| Speed Handpiece Series | Primary predicate | ||
| K902402 SW Non-Fiber | |||
| Optic Handpiece | Reference predicates | ||
| K982593 and K960719 430 | |||
| Series High Speed | |||
| Handpiece | |||
| Indications for | |||
| Use | 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. | High-speed dental | ||
| handpieces used by trained | |||
| dental professionals for | |||
| drilling in the oral cavity for | |||
| procedures including but | |||
| not limited to caries | |||
| removal, restorative work | |||
| and crown preparations. | High-speed dental | ||
| handpieces used intraorally | |||
| by trained dental | |||
| professionals for drilling | |||
| and preparation of dental | |||
| caries for restoration such | |||
| as fillings. | |||
| Material | |||
| composition | Stainless steel, aluminum; | ||
| optional bead blasted | |||
| outer surface | Stainless steel, aluminum | Stainless steel, aluminum | |
| Components | High speed pneumatic | ||
| driven handpiece with | |||
| option of twin fused solid | |||
| rod fiber optic with | |||
| ceramic lube free bearings | High speed pneumatic | ||
| driven handpiece with | |||
| ceramic bearings | High speed pneumatic | ||
| driven handpiece with | |||
| ceramic bearings with | |||
| option of bundled fiber | |||
| optics; autochuck and lube | |||
| free bearings | |||
| Biocompatibility | Identical material | ||
| composition and | |||
| manufacturing process to | |||
| the predicates | The design incorporates | ||
| either 400 series stainless | |||
| steel or 300 series stainless | |||
| steel for device | |||
| construction. These | |||
| materials are known for | |||
| their corrosion resistance | |||
| and are biocompatible with | |||
| tissue encountered during | |||
| use. | The design incorporates | ||
| either 400 series stainless | |||
| steel or 300 series stainless | |||
| steel for device | |||
| construction. These | |||
| materials are known for | |||
| their corrosion resistance | |||
| and are biocompatible with | |||
| tissue encountered during | |||
| use. These materials are | |||
| identical to the predicate | |||
| 430 series high speed | |||
| handpiece currently | |||
| manufactured by Star | |||
| Dental. | |||
| Sterilization | Sterilization validation in | ||
| accordance with | |||
| ANSI/AAMI ST79:2010 & | |||
| A4:2013, AAMI/ANSI/ISO | |||
| 14937:2009 and | |||
| ANSI/AAMI ST81:2004 | |||
| (R2010) | Sterilization validation | ||
| report references AAMI TIR | |||
| No. 12-1994 | Sterilization validation | ||
| carried out in accordance | |||
| with the FDA June 1996 | |||
| guidance document to | |||
| dental handpiece | |||
| manufacturers. | |||
| Performance | Capable of reaching | ||
| rotational speeds of | |||
| 350,000 to 450,000 rpms | |||
| at a recommended air | |||
| pressure of 38-43 PSI; | |||
| delivers on average up to | |||
| 20 watts of power | |||
| providing .269 oz.-in. of | |||
| stall torque. | |||
| Performance testing in | |||
| compliance with ISO | |||
| 14457:2012 Dentistry - | |||
| Handpieces and motors | Capable of reaching | ||
| rotational speeds of | |||
| 430,000 rpms at a | |||
| recommended air pressure | |||
| of 30 PSI; delivers on | |||
| average 14 watts of power | |||
| providing .181 oz.-in. of | |||
| stall torque. | |||
| Performance testing in | |||
| compliance with ISO 7785- | |||
| 1 Dental Handpieces – Part | |||
| 1: High-speed air turbine | |||
| handpieces | Capable of reaching | ||
| rotational speeds of | |||
| 430,000 rpms at a | |||
| recommended air pressure | |||
| of 34 PSI; delivers on | |||
| average 14 watts of power | |||
| providing .181 oz.-in. of | |||
| stall torque. | |||
| Performance testing in | |||
| compliance with ISO 7785- | |||
| 1 Dental Handpieces – Part | |||
| 1: High-speed air turbine | |||
| handpieces | |||
| Risk analysis | ISO14971:2012 Medical | ||
| devices - Application of | |||
| risk management to | |||
| medical devices | Risk analysis at time of | ||
| submission unknown. | |||
| Current risk analysis per | |||
| ISO14971:2012 – | |||
| Application of risk | |||
| management to medical | |||
| devices. | Risk analysis at time of | ||
| submission unknown. | |||
| Current risk analysis per | |||
| ISO14971:2012 – | |||
| Application of risk | |||
| management to medical | |||
| devices. |
6
VII. PERFORMANCE DATA
Performance testing was completed in accordance with ISO 14457:2012 Dentistry – Handpieces and motors.
Sterilization validation for the sterilization of the handpieces was performed in accordance to ANSI/AAMI ST79:2010 & A4:2013, AAMI/ANSI/ISO 14937:2009 and ANSI/AAMI ST81:2004 (R2010).
A risk analysis for the 430 Torque High-Speed Handpiece Series was developed using ISO14971:2012.
7
VIII. CONCLUSION
Based upon the comparison of technological characteristics, demonstrated through bench testing and intended use, the 430 Torque High-Speed Handpiece Series is substantially equivalent to the predicate devices.