(210 days)
No
The description focuses on the mechanical and performance aspects of a dental handpiece, with no mention of AI or ML capabilities.
Yes
The device is intended for the removal of carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations, restorations, and for polishing teeth, all of which are direct treatments or modifications to the body.
No.
The device is used for removal, reduction, preparation, and polishing, which are all treatment functions, not diagnostic ones.
No
The device description clearly states it is a hand-held instrument with an integrated air-powered turbine and chucking device, made of stainless steel. This indicates a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for physical procedures on teeth (removing material, preparing cavities, polishing). This is a direct intervention on the patient's body.
- Device Description: The description details a mechanical instrument with a turbine and chucking device, designed for high-speed rotation. This is a tool for physical manipulation.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with such specimens in this manner.
The device is a dental handpiece, which is a surgical/dental instrument used directly on the patient.
N/A
Intended Use / Indications for Use
The Dental High-speed Handpiece Halley Series is intended for the removal of carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations, restorations, and for polishing teeth. They are designed for use by a trained professional in the field of general dentistry.
Product codes (comma separated list FDA assigned to the subject device)
EFB
Device Description
The Dental High-speed Handpiece Halley Series is a hand-held instrument which propelled by a small air-powered turbine (or rotor), capable of high speed, which is integrated into the head of the handpiece and has a chucking device coaxial with the turbine. The main materials of the dental handpiece and accessories are stainless steel. Rotation speed range is around 330,000-390,000 rpm. Our couplings are in compliance with the Type 1, Type 3 of the recognized standard ISO 9168 Hose connectors for air driven dental handpieces, and vary with the most famous brands in the world. For our device, there was no any other previous 510(k) clearance before this submission.
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 professional in the field of general dentistry.
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)
The Dental High-speed Handpiece Halley Series was developed taking into consideration all applicable technical standards, internal specifications and FDA guidance documents. The Dental Highspeed Handpiece Halley Series in compliance with the applicable internal standards was verified through bench testings.
Clinical testing has not been performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA acronym is in a blue box, and the full name of the agency, "U.S. Food & Drug Administration," is in blue text.
MicroP Technology (Taiwan), Inc. Ina Lin Official Correspondent No.40, Junghe Tsuen, Minshiung Township Chiavi Countv. 621 Taiwan
July 24, 2018
Re: K173943
Trade/Device Name: Dental High-speed Handpiece and Accessories Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I Product Code: EFB Dated: June 22, 2018 Received: June 25, 2018
Dear Ina Lin:
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. 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 CFR Part 807); labeling (21 CFR Part
1
801); medical device 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.
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mary S. Runner -S
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/0 description: The image shows the logo for MicroP Dental. The logo features a stylized, orange-colored symbol resembling a mountain range or an abstract letter 'M' at the top. Below the symbol, the text "MicroP DENTAL" is written in a gray, sans-serif font, with "MicroP" appearing larger than "DENTAL".
Dental High-speed Handpiece Halley Series
| Chapter 4 - Indications for Use Statement | |
|---|---|
| 510(k) Number | |
| (if know) | K173943 |
| Device Name | Dental High-speed Handpiece Halley Series |
| Indications for Use | The Dental High-speed Handpiece Halley Series is intended for |
| the removal of carious material, reducing hard tooth structure, | |
| cavity preparation, finishing tooth preparations, restorations, and | |
| for polishing teeth. They are designed for use by a trained | |
| professional in the field of general dentistry. | |
| Prescription Use | |
| (per 21 CFR 801 Subpart D) | X AND/OR Over-The-Counter Use (per 21 CFR 801 Subpart C) |
| PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER | |
| PAGE IF NEEDED | |
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
| Code: FDA01 | Version: A |
| Revision Status: 0 | Issuing Date: 2017/12/22 |
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Image /page/3/Picture/0 description: The image shows the logo for MicroP Dental. The logo features a stylized, orange, geometric shape resembling a stylized letter 'M' or a mountain peak. Below the symbol, the text "MicroP DENTAL" is written in a simple, sans-serif font, with "MicroP" in a larger, bolder typeface than "DENTAL."
Dental High-speed Handpiece Halley Series
FDA01-05 Page 5-1
Chapter 5 - 510(k) Summary
| Submitter | 807.92(a) (1) |
|---|---|
| Submitter | MicroP Technology (Taiwan), Inc. |
| Address | No.40, Junghe Tsuen, Minshiung Township, |
| Chiayi County 62153, Taiwan (R.O.C.) | |
| Contact Person | Ina Lin |
| ina.lin@micro-p.com.tw | |
| Telephone | +886-5-2268808 (Tel.) |
| +886-5-2266697 (Fax) | |
| Date Prepared | June 25, 2018 |
Subject Device
| Subject Device | 807.92(a)(2) | |
|---|---|---|
| Trade Name | Dental High-speed Handpiece Halley Series | |
| K-number | K173943 | |
| Applicant | MicroP Technology (Taiwan), Inc. | |
| Classification Name | Handpiece, Air-powered, Dental | |
| Regulation Number | 872.4200 | |
| Classification Code | EFB | |
| Device Class | I |
Predicate Devices
| Predicate Device | MASTERtorque LUX 8900 L |
|---|---|
| K-number | K130560 |
| Applicant | KALTENBACH & VOIGT GMBH (KaVo) |
| Classification Name | Handpiece, Air-powered, Dental |
| Regulation Number | 872.4200 |
| Classification Code | EFB |
| Device Class | I |
| Reference Device | MDK handpieces |
|---|---|
| K-number | K141886 |
| Applicant | MODERN KOREA CO., LTD. |
| Classification Name | Handpiece, Air-powered, Dental |
| Regulation Number | 872.4200 |
| Classification Code | EFB |
| Device Class | I |
We chose KaVo's MASTERtorque LUX 8900 L to be our primary predicate device because our device is much more similar with this device. However, there is still some deficiencies that we chose MDK handpieces to be our reference device. For more details, please see the comparison table in the document FDA01-12 Substantial Equivalence Discussion.
Device Description
807.92(a)(4)
The Dental High-speed Handpiece Halley Series is a hand-held instrument which propelled by a small air-powered turbine (or rotor), capable of high speed, which is integrated into the head of the handpiece and has a chucking device coaxial with the turbine. The main materials of the dental handpiece and accessories are stainless steel. Rotation speed range is around 330,000-390,000 rpm. Our couplings are in compliance with the Type 1, Type 3 of the recognized standard ISO 9168 Hose connectors for air driven dental handpieces, and vary with the most famous brands in the world. For our device, there was no any other previous 510(k) clearance before this submission.
| Code: | FDA01 |
|---|---|
| ------- | ------- |
Version: C
Revision Status: 0
Issuing Date: 2018/6/13
807.92(a)(3)
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Image /page/4/Picture/0 description: The image shows the logo for MicroP Dental. The logo consists of an orange geometric shape resembling a stylized tooth or mountain range above the text "MicroP DENTAL" in a dark gray sans-serif font. The word "MicroP" is larger and bolder than the word "DENTAL" which is stacked below it.
Dental High-speed Handpiece Halley Series
Indications for Use
807.92(a)(5)
The Dental High-speed Handpiece Halley Series is intended for the removal of carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations, and for polishing teeth. They are designed for use by a trained professional in the field of general dentistry.
Device Technological Characteristics
807.92(a)(6)
The Dental High-speed Handpiece Halley Series is similar in the operating principle, technical data and performance to other high speed dental handpieces currently in the US commercial distribution. Examples of substantially equivalent devices include the MASTERtorque LUX 8900 L (K130560) and MDK handpieces (K141886). The following table is a comparison of the proposed device to the predicate devices.
General Specification
| Head Size | Miniature | Standard | Torque |
|---|---|---|---|
| Rotation Speed | 330,000~390,000 min | ||
| (at the recommended drive air pressure.) | 330,000~390,000 min | ||
| (at the recommended drive air pressure.) | 310,000~370,000 min | ||
| (at the recommended drive | |||
| air pressure.) | |||
| Bur Type | ISO 1797-1ø 1.59 ~ 1.60 mm Standard Bur | ||
| Max. Bur Length | 21 mm | ||
| Max. Working Part | |||
| Diameter | ø 2 mm | ||
| Recommended Drive Air | |||
| Pressure | 40 psi | ||
| Operating Drive Air | |||
| Pressure Range | 36~43 psi | ||
| Max. Air Consumption | Dental High-speed Handpiece Halley Series is intended for the removal of carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations, restorations, and for polishing teeth. They are designed for use by a trained professional in the field of general dentistry. | Identical | |
| Device design | |||
| Operational modes | Through the tubes | Identical | Identical |
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Image /page/6/Picture/0 description: The image shows the logo for MicroP Dental. The logo features an orange geometric shape resembling a stylized letter 'M' or a mountain range. Below the shape, the text 'MicroP DENTAL' is written in a bold, sans-serif font, with 'MicroP' in a larger size than 'DENTAL'.
MicroP Technology (Taiwan), Inc.
Dental High-speed Handpiece Halley Series
| | connected to a dental
unit, the air-powered
handpiece receives
the air for rotation, the
cooling water and light
for illumination of the
operation area. | | |
|--------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|---------------------------------|
| Air/water ports | 4 holes | Identical | Identical |
| Fiber optics | Y/N | Identical | Identical |
| Head dimensions | Height: 13.1 mm
Diameter:11.2 and 12.2 mm | Height: 13.0 mm
Diameter:12.5 mm | Not mentioned |
| Type of chuck | Push button | Identical | Identical |
| Composition of materials | | | |
| Materials used in patient-
contacting surfaces (external) | Stainless steel | Identical | Stainless steel and
titanium |
| Materials used in the water/air
tubes (internal) | Stainless steel | German silver and
stainless steel | Stainless steel and
titanium |
| Technical Specifications | | | |
| Chuck design | Push button | Identical | Identical |
| Bur extraction force | 25N | Up to 24 N | 30N |
| Maximum air/water pressure | 36psi to 43psi
(40psi recommended) | 30-61 psi
(41psi recommended) | Identical |
| Speed in rpms | 330,000-390,000rpm | 340,000-400,000 rpm | 320,000-400,000rpm |
| Compliance standards for
shanks | ISO 1797-1 | Identical | Identical |
| Compliance standards for hose
connections | ISO 9168 | Identical | Identical |
| Lubricant | | | |
| Legally-marketed lubricant
(identify 510(k)) | Pana-Spray made
by NSK (K052700) | KaVo
QUATTROcare
(K071288) | Identical |
Non-clinical Testing Summary
807.92(b) (1)
The Dental High-speed Handpiece Halley Series was developed taking into consideration all applicable technical standards, internal specifications and FDA guidance documents. The Dental Highspeed Handpiece Halley Series in compliance with the applicable internal standards was verified through bench testings.
The following standards were considered:
| • ISO 14457, Dentistry — Handpieces and motors | 2012 |
|---|---|
| • ISO 1797-1, Dentistry — Shanks for rotary instruments — Part 1: Shanks made of metals | 2011 |
| • ISO 5349-1, Mechanical vibration — Measurement and evaluation of human exposure to hand-transmitted vibration — Part 1: General requirements | 2001 |
| • ISO 9168, Dentistry — Hose connectors for air driven dental handpieces | 2009 |
| • IEC 62366, Medical devices — Application of usability engineering to medical devices | 2007 |
| • ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process | 2009 |
| • ISO 10993-5, Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity | 2009 |
| • ISO 10993-10, Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization | 2010 |
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Image /page/7/Picture/0 description: The image shows the logo for MicroP Dental. The logo features a stylized, orange, three-pointed star-like shape above the text "MicroP DENTAL" in a bold, sans-serif font. The word "MicroP" is larger than the word "DENTAL".
MicroP Technology (Taiwan), Inc.
Dental High-speed Handpiece Halley Series
| • | ISO 17664 Sterilization of medical devices — Information to be provided by the manufacturer for the processing of resterilizable medical devices | 2004 |
|---|---|---|
| • | ISO 17665-1 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices | 2006 |
| • | EN 60601-1 Medical electrical equipment — Part 1: General requirements for basic safety and essential performance | IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) + AM1 (2012) or IEC 60601-1: 2012; EN 60601-1: 2006 + A1: 2013 + AC: 2014 |
| • | EN 60601-1-2 Medical electrical equipment — Part 1-2: General Requirements for basic safety and essential performance, Collateral standard: Electromagnetic compatibility | IEC 60601-1-2: 2014; EN 60601-1-2:2015 |
| • | EN 62471 Photobiological safety of lamps and lamp systems | IEC 62471: 2006; EN 62471: 2008 |
| Clinical Testing Summary 807.92(b)(2) | ||
| Clinical testing has not been performed. | ||
| Guidance documents used: | ||
| 1. | Format for Traditional and Abbreviated 510(k)s | |
| 2. | Bundling Multiple Devices or Multiple Indications in a Single Submission | |
| 3. | Dental Handpieces - Premarket Notification [510(k)] Submissions | |
| 4. | The New 510(k) Paradigm, Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications. | |
| 5. | How to Study and Market Your Device | |
| 6. | 510(k) Format Tips | |
| 7. | Content of a 510(k) | |
| 8. | eCopy Program for Medical Device | |
| 9. | eSubmitter Quick Guide | |
| 10. | Indications for Use Statement | |
| 11. | Labeling Regulatory Requirements for Medical Devices | |
| 12. | Premarket Notification Truthful And Accurate Statement | |
| 13. | Refuse to Accept Policy | |
| 14. | Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling | |
| 15. | The 510(k) Program-Evaluating Substantial Equivalence | |
| Conclusion 807.92(b)(3) | ||
| Based upon the comparison of technological characteristics, demonstrated through bench testing and intended use, the Dental High-speed Handpiece Halley Series is substantially equivalent to the predicate devices. |