(279 days)
The PRO M CLASS is used by dental professionals for orthodontic procedures using a root canal instrument and tightening and loosening an abutment screw to fix and remove the abutment on a dental implant in prosthodontic treatment.
The PRO M CLASS is an AC-powered device that includes a 'Motor Handpiece', 'Contra angle Handpiece', 'Charger unit' and 'AC/DC Adaptor' for grinding, cutting, polishing and screw driver work in dental oral use. The PRO M CLASS uses the battery inside the motor handpiece as a power source to rotate the micromotor to transmit the generated rotational power to the contra angle. Dental treatment is performed using the rotational power obtained by this. The motor turned by the power converted into DC 5.0V by controller delivers its turning power to the file through spin to perform punching, cutting and removing functions. The hand-piece can be operated, stopped and set/adjusted on/in its speed, torque and turning direction by handling of the controller.
This document is a 510(k) K213897 clearance letter for the Saeyang Microtech Co., Ltd. PRO M CLASS dental handpiece. It asserts substantial equivalence to a predicate device and reference devices but does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The document focuses on regulatory compliance and comparison to previously cleared devices. Therefore, the requested information cannot be extracted from the provided text.
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Image /page/0/Picture/0 description: The image shows 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, 2022
Saeyang Microtech Co., Ltd. % DongHa Lee RA Consultant KMC, Inc Room no. 1709, 123, Digital-ro 26-gil, Guro-gu, Seoul 08390 SOUTH KOREA
Re: K213897
Trade/Device Name: Pro M Class Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I, reserved Product Code: EKX Dated: June 16, 2022 Received: June 21, 2022
Dear Yeon Woo:
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.
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
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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 (OS) 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 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).
Sincerely,
Michael E. Adjodha, M. ChE. 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
510(k) Number (if known) K213897
Device Name
PRO M CLASS
Indications for Use (Describe)
The PRO M CLASS is used by dental professionals for orthodontic procedures using a root canal instrument and tightening and loosening an abutment screw to fix and remove the abutment on a dental implant in prosthodontic treatment.
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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V. 510(k) Summary (K213897)
This summary of 510(K) - substantial equivalence information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: June 16, 2022
1. Applicant / Submitter
Saeyang Microtech Co., Ltd. 348, Seongseo-ro, Dalseo-gu, Daegu, Republic of Korea, Tel: +82-53-582-9000~2
2. Submission Correspondent
DongHa Lee (Consultant, KMC, Inc.) Address: Room no. 1709, 123, Digital-ro 26-gil, Guro-gu, Seoul, 08390, South Korea Tel: +82-70-8965-5554 Fax: +82-2-856-5904 Email: dhlee@kmcerti.com
3. Device
| ■ Trade Name: | PRO M CLASS |
|---|---|
| ■ Common Name: | AC-Powered Direct Drive Handpiece |
| ■ Classification Name: | Dental handpiece and accessories |
| ■ Classification Product Code: | EKX |
| ■ Classification Regulation: | 21 CFR 872.4200 |
| ■ Device Class: | Class I |
4. Predicate Device
- Predicate Devices: (K111616) E-CUBE
■ Reference Devices: (K161500) MEG-TORQ (K110278) Cordless Prosthodontic Screwdriver with Torque Calibration System, Model iSD900
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5. Description
■ General
The PRO M CLASS is an AC-powered device that includes a 'Motor Handpiece', 'Contra angle Handpiece', 'Charger unit' and 'AC/DC Adaptor' for grinding, cutting, polishing and screw driver work in dental oral use.
[Note] The Dental Bur is not provided with the subject device.
■ Technological Characteristics
The PRO M CLASS uses the battery inside the motor handpiece as a power source to rotate the micromotor to transmit the generated rotational power to the contra angle. Dental treatment is performed using the rotational power obtained by this.
. Principle of Operation
The motor turned by the power converted into DC 5.0V by controller delivers its turning power to the file through spin to perform punching, cutting and removing functions. The hand-piece can be operated, stopped and set/adjusted on/in its speed, torque and turning direction by handling of the controller.
6. Indication for use
The PRO M CLASS is used by dental professionals for orthodontic procedures using a root canal instrument and tightening and loosening an abutment screw to fix and remove the abutment on a dental implant in prosthodontic treatment.
7. Basis for Substantial Equivalence
The PRO M CLASS is substantially equivalent to the predicate device in terms of intended use, technical & performance characteristic, electrical power, design, and function.
Also, the Indications for Use for the subject devices is identical to the predicate device (K111616) for endodontic and orthodontic procedure in dental oral use, and the reference devices (K161500, K110278) for screw-driver function in dental implant in prosthodontic treatment.
The electrical safety and performance testing performed on the subject device demonstrate that the difference in external design and some technological characteristics compared predicate device does not raise any new issues.
The sterilization validation performed on the subject device demonstrates that the difference in sterilization method does not raise any new issues. Any of difference (chuck design and lubricant) also does not raise any new issues of safety and effectiveness as compared to the predicate device.
Based on the comparison charts below and test results provided in this submission, we conclude that the subject device is substantially equivalent to the predicate device.
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| 510(k) No. | Subject Device | Predicate Device | Reference Device 1 | Reference Device 2 | Comparison |
|---|---|---|---|---|---|
| Not yet | K111616 | K161500 | K110278 | ||
| Device Name | PRO M CLASS | E-CUBE | MEG-TORQ | Cordless ProsthodonticScrewdriver with TorqueCalibration System, ModeliSD900 | |
| Manufacturer | Saeyang Microtech Co., Ltd. | Saeshin Precision Co., Ltd. | MICRO-NX Co., Ltd. | Nakanishi, Inc. | |
| RegulationNumber | 21 CFR 872.4200 | 21 CFR 872.4200 | 21 CFR 872.4200 | 21 CFR 872.4200 | Same |
| Product Code | EKX | EKX | EKX | EKX | Same |
| Regulatory Class | Class I | Class I | Class I | Class I | Same |
| Use | RX only | RX only | RX only | RX only | Same |
| Indications forUse Statement | The PRO M CLASS is used by dentalprofessionals for orthodontic andendodontic procedures using a rootcanal instrument and tightening andloosening an abutment screw to fix andremove the abutment on a dentalimplant in prosthodontic treatment. | The E-CUBE is indicated foruse by dentists in standardendodontic proceduresusing rotary endodonticfiles and rotary endodonticdrills (Gates-Glidden). | This product is a cordlessmotor handpiece systemintended for tightening andloosening an abutmentscrew to fix and remove theabutment on a dentalimplant in prosthodontictreatment. | This product is a cordlessmotor handpiece systemintended for tightening andloosening an abutmentscrew to fix and remove theabutment on a dentalimplant in prosthodontictreatment. | Similar 1) |
| Component | Contra-Angle HandpieceMotor HandpieceChargerAdapter | Contra-Angle HandpieceMotor HandpieceController,Adapter | Contra-Angle HandpieceMotor HandpieceChargerAdapter | Contra-Angle HandpieceMotor HandpieceCharger | Same |
| OperationalMode | Speed control, Torque control, Rotateboth forward/reverse operation | Speed control, Torquecontrol, Rotate bothforward/reverse operation | Speed control, Torquecontrol, Rotate bothforward/reverse operation | Speed control, Rotate bothforward/reverse operation | Same |
| Principle ofOperation | The motor turned by the powerconverted into DC voltage by controllerdelivers its turning power to the filethrough spin to perform punching,cutting and removing functions. Thehand-piece can be operated stoppedand set/adjusted on/in its speed,torque and turning direction byhandling of the controller. | The motor turned by thepower converted into DCvoltage by controllerdelivers its turning power tothe file through spin toperform punching, cuttingand removing functions.The hand-piece can beoperated stopped andset/adjusted on/in itsspeed, torque and turningdirection by handling of thecontroller. | The motor turned by thepower converted into DCvoltage by controllerdelivers its turning powerto the file through spin toperform punching, cuttingand removing functions.The hand-piece can beoperated stopped andset/adjusted on/in itsspeed, torque and turningdirection by handling of thecontroller. | The motor turned by the powerconverted into DC voltage bycontroller delivers its turning powerto the file through spin to performpunching, cutting and removingfunctions. The hand-piece can beoperated stopped andset/adjusted on/in its speed, torqueand turning direction by handling ofthe controller. | Same |
| Electrical Safety | Complied with IEC 60601-1 | Complied with IEC 60601-1 | Complied with IEC 60601-1 | Complied with IEC 60601-1 | Same |
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| ectromagnet Compatibility | omplied with IEC 60601-1-2 | omplied with IEC 60601-1 | omplied with IEC 60601- | Complied with IEC 60601 | Same | ||||
|---|---|---|---|---|---|---|---|---|---|
| evice Design – Motor Handpiece Battery Type | Li-Ion (DC 3.7 V, 800 | nAH | None | i-Polyme | hium (DC 2.4V, 0.3V | Different 2) | |||
| 4:1 | 1:1 | 4:1 | |||||||
| ាន សាសនា សាសនា សាសនា ន ការបោយសារ ប្រជាជាតិ ស្រុកស្រុក ប្រចាំប្រជាជាតិ | 00010 5000 z | 5 1901 EOO | 3,000 | 3,250 | |||||
| - | 1.3 | ||||||||
| 160:1 | - | - | - | None | - | ||||
| 15-70 | - | - | - | 15-60 | - | ||||
| שלו או האירופי מערשים של מערכת משום של מערכת של המונים של המועד של המושב של המושב של המושב של המושב של המושב של המושב של המושב של המושב של המושב של המושב של המושב של המושב ש | 5-35 | । | 5-35 | ||||||
| I | 320:1 | - | - | None | |||||
| 15-25 | 1 | 1 | - | 15-25 | |||||
| וני שנים מורים חיצוניים | 10-40 | 1 | 10-40 | ||||||
| evice Design – Contra-Angle Handpier | JS303F, SUS420 Head and Chuck | (는( | S303F, SUS42 ead and Chuc | Jnknowi | Jnknowi | Same | |||
| huk Desig | ype 1 by ISO 1797-1 ype 3 by ISO 1797-1 ype 3 by ISO 1797-1 | ype 1 by ISO 1797- | ype 1 by ISO 1797- | ype 1 by ISO 1797 | Same | ||||
| Coupling Dimensio | omplied with ISO 3964 | omplied with ISO 396 | omplied with ISO 39 | omplied with ISO 396 | Same | ||||
| terilizatic | utoclave by User at 135℃ for | Non-sterile | 32°C for 4min | Non-sterile Lutoclave by User 1℃ for 20min or32°C for 15mir | Different | ||||
| evice Design – Charger & Adapte | |||||||||
| Input | AC 100-240V, 50~60 Hz, 0.6A | 100-240V, 47-63H | AC 100 ~ 240V, 50~60 | AC 100 ~ 240V, 50~60 H | Different | ||||
| ubrican | |||||||||
| ាក កន្លង់ អ្នកន្ទនា រហូត ក្រុងប្រទេ ការចេញពី ព្រះបាទប្រយោ ។ សាខា សាសនា របស់ប្រយោ ។ | na-Spray made by | K052700 | Inknow | Jnknow | Jnknow | Different |
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| Substantial Equivalence Discussion |
|---|
| Discussion |
| Similar 1)The subject device has two main indications for use. The indications for use is based on the motor rotation speed and torque according to the gear ratio.First indication for use is for orthodontic and endodontic procedures is the same as the predicate device (K111616)Second indication for use is for tightening and loosening an abutment screw to fix and remove the abutment on a dental implant in prosthodontic treatment is the same as the reference devices (K161500, K110278). |
| Different 2)The motor handpiece is supplied power from the internal rechargeable battery and battery voltage is the different.The different was verified according to IEC 60601-1, IEC 80601-2-60 and IEC 62133-2. The testing results show that the difference does not raise any problems in the safety and effectiveness. |
| Similar 3)Motor rotation speed as 2,000-10,000 rpm (on gear ratio 1:1) and 500-2,500 rpm (on gear ratio 4:1) are for orthodontic and endodontic procedures. It is similar to the predicate device (K111616).Motor rotation speed as 15-70 rpm (torque 5-35 on gear ratio 160:1) is for prosthodontic treatment as tightening and loosening an abutment screw to fix and remove. It is similar to the reference device1 (K161500).Motor rotation speed as 15-25 rpm (torque 10-40 on gear ratio 320:1) is for prosthodontic treatment as tightening and loosening an abutment screw to fix and remove. It is the same as the reference device2 (K110278).Performance test (Bench test) according to ISO 14457 also was conducted. The testing results show that the difference does not raise any problems in the safety and effectiveness. |
| Different 4)The Sterilization method is slightly different from the predicate device (K111616). The sterilization was validated according to ISO 17665-1 and the differences in sterilization methods show that it does not raise any problems in the safety and effectiveness. |
| Different 5)The charger is supplied power from an AC/DC adapter. The power input of the AC/DC adapter is different from the predicate device (K111616). The different was verified according to IEC 60601-1, IEC 80601-2-60 and IEC 60601-1-2. The testing results show that the difference does not raise any problems in the safety and effectiveness. |
| Different 6)The subject device uses a legally-marketed lubricant (K052700). It has been evaluated and cleared by FDA about the safety and effectiveness. |
| ConclusionThe PRO M CLASS is substantially equivalent to the predicate device and the reference devices in terms of intended use, technical & performance characteristic and function.Also, the Indications for Use for the subject devices is identical to the predicate device (K111616) for endodontic and orthodontic procedure in dental oral use, and the reference devices (K161500, K110278) for screw-driver function in dental implant in prosthodontic treatment.The electrical safety and performance testing performed on the subject device demonstrate that the difference in some technological characteristics compared predicate device and reference devices does not raise any new issues |
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The steriizitor perforned on the subject eleves that the diference in take an taise any niel ifse any nifaste, any nifines any nifines any nifines any nifines any nifine is c
§ 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.