(266 days)
Not Found
No
The description focuses on mechanical functions (torque, speed, direction) and standard performance testing, with no mention of AI/ML terms or capabilities.
No.
This device is used for tightening and loosening screws on dental implants, which is a mechanical function to connect components, rather than for directly treating a disease or condition.
No
This device is a cordless motor handpiece system for tightening and loosening abutment screws on dental implants, which is a therapeutic or procedural function, not a diagnostic one.
No
The device description explicitly states it consists of a torque driver, a charge adapter, and a charge cradle, which are hardware components. The performance studies also include testing related to hardware standards (ISO 14457, sterilization, electrical safety, EMC).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to tighten and loosen abutment screws on dental implants in prosthodontic treatment. This is a direct interaction with a patient's body for a therapeutic/restorative purpose.
- Device Description: The device is a cordless torque driver used for connecting and disconnecting dental implant abutments. This is a mechanical tool used in a surgical/restorative procedure.
- Lack of IVD Characteristics: IVD devices are 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 perform any such function.
The device is a medical device used in a clinical setting for a dental procedure, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This product is a cordless motor handpiece system intended for tightening and loosening an abutment screw to fix and remove the abutment on a dental implant in prosthodontic treatment.
Product codes (comma separated list FDA assigned to the subject device)
EKX
Device Description
This device is a cordless torque driver used for connecting and disconnecting dental implant abutments used in dentistry. The torque driver function includes adjustment of spinning direction (forward and reverse), speed and torque. The maximum torque is 35 Ncm. The device consists of a torque driver, a charge adapter and a charge cradle.
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
Not Found
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 following properties were tested based on the referenced standards. All the test results support substantial equivalence to the predicate devices.
- Performance test in accordance with ISO 14457:2012 Dentistry Handpieces and motors
- . Sterilization validation testing in accordance with ANSVAAMI ST79, ISO17665-1, ISO 17665-2, ISO 11138-1, and ISO11138-3
- · Electrical safety and EMC test in accordance with IEC 60601-1, IEC 60601-1-6, EN 606011-1-2, EN 61000-3-2, EN 61000-3-3
No clinical performance testing was provided in the submission.
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.
Not Found
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/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized caduceus or a representation of the human profile in triplicate.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 22, 2017
MICRO-NX Co., Ltd % Ms. Priscilla Chung Regulatory Affairs Consultant Lk Consulting Group USA, Inc. 800 Roosevelt Ste 417 Irvine. California 92606
Re: K161500 Trade/Device Name: MEG - TORQ Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: Class I Product Code: EKX Dated: January 24, 2017 Received: January 25, 2017
Dear Ms. Chung:
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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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" (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 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,
Michael J. Ryan -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
2
Indications for Use
510(k) Number (if known)
Device Name
MEG-TORQ
Indications for Use (Describe)
This product is a cordless motor handpiece system intended for 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 CER 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
(K161500)
Date: Feb 14, 2017
1. Applicant / Submitter:
MICRO-NX Co., Ltd. 37, Dalseong2chadong 3-ro, Guji-myeon, Dalseong-gun, Daegu 711-891 REPUBLIC OF KOREA Tel: +82-53-611-0071 Fax:+82-53-611-0074
2. Submission Correspondent:
Priscilla Chung LK Consulting Group USA, Inc. 800 Roosevelt Ste 417, Irvine CA 92620 Phone: 714-202-5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com
3. Device:
| Proprietary Name: | MEG-TORQ |
|---|---|
| Common Name: | Dental Implant Torque Driver |
| Classification Name: | Handpiece, Direct Drive, AC-powered |
| Classification: | Class I, 21 CFR 872.4200 |
| Classification Product Code: | EKX |
4. Predicate Device:
CORDLESS PROSTHODONTIC SCREWDRIVER WITH TORQUE CALIBRATION SYSTEM, MODEL ISD900 by NAKANISHI Co., Ltd. (K110278)
5. Device Description:
This device is a cordless torque driver used for connecting and disconnecting dental implant abutments used in dentistry. The torque driver function includes adjustment of spinning direction
4
(forward and reverse), speed and torque. The maximum torque is 35 Ncm. The device consists of a torque driver, a charge adapter and a charge cradle.
6. Indications for Use:
This product is a cordless motor handpiece system intended for tightening and loosening an abutment screw to fix and remove the abutment on a dental implant in prosthodontic treatment.
7. Performance Data(Non-Clinical):
The following properties were tested based on the referenced standards. All the test results support substantial equivalence to the predicate devices.
- Performance test in accordance with ISO 14457:2012 Dentistry Handpieces and motors
- . Sterilization validation testing in accordance with ANSVAAMI ST79, ISO17665-1, ISO 17665-2, ISO 11138-1, and ISO11138-3
- · Electrical safety and EMC test in accordance with IEC 60601-1, IEC 60601-1-6, EN 606011-1-2, EN 61000-3-2, EN 61000-3-3
Performance Data(Clinical): 8.
No clinical performance testing was provided in the submission.
9. Substantial Equivalence
MEG-TORQ is substantially equivalent to ISD900 (K110278). The following comparison table is presented to demonstrate substantial equivalence.
The intended use of the subject device is the same as the predicate device. The subject device is also similar to the predicate device in terms of operational modes, type of chuck, patient contacting part, and shank type which confirms to ISO1797-1. The differences between the subject device and the predicate devices are device dimensions, speed in rpm, and torque options. However, the non-clinical performance test results provided in this submission support that the subject device is substantially equivalent to the predicate device. Especially, the maximum speed and torque test was performed to verify that the use of the subject device with the highest rpm does not shear off the abutment screw. The test results showed that this difference does not raise a concern in this regard.
| Submission Device | Predicate Device | |
|---|---|---|
| 510(k) Number | K161500 | K110278 |
| Device Name | Meg-Torque | CORDLESS PROSTHODONTIC |
| SCREWDRIVER WITH TORQUE | ||
| CALIBRATION SYSTEM, MODEL | ||
| ISD900 |
5
| Common Name | Handpiece, Direct Drive, AC-
Powered | Handpiece, Direct Drive, AC-
Powered |
|------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | MICRO-NX Co., Ltd | NAKANISHI Co., Ltd. |
| Intended Use | This product is a cordless motor
handpiece system intended for
tightening and loosening an
abutment screw to fix and remove
the abutment on a dental implant in
prosthodontic treatment. | This product is a cordless motor
handpiece system intended for
tightening and loosening an abutment
screw to fix and remove the abutment
on a dental implant in prosthodontic
treatment. |
| Operational modes | Speed control, Torque control,
Rotate both forward/reverse
operation, Calibration | Speed control, Torque control, Rotate
both forward/reverse operation,
Calibration |
| Air/water ports | N/A | N/A |
| Fiberoptics | N/A | N/A |
| Dimensions | 30×28×200(mm)
(Width×Length×Height) | 27×29×207(mm)
(Width×Length×Height) |
| Type of chuck | Push Button Chuck | Push Button Chuck |
| Coupling dimensions | N/A | N/A |
| Chemical
composition of the
waterlines | N/A | N/A |
| The patient-
contacting portions
of the device | The rotary instrument. | The rotary instrument. |
| Light intensity | N/A | N/A |
| Bur extraction force | N/A | N/A |
| Maximum air/water
pressure | N/A | N/A |
| Speed in rpms | 15, 30, 45, 60 rpm | 15, 20, 25rpm |
| Torque | 5,15,20,25,30,35Ncm | 10-40Ncm in 1 or 5 Ncm increments |
| Conformance with
standards for shanks | Screwdriver shank ø2.35mm
ISO1797-1 Type1 | Screwdriver shank ø2.35mm
ISO1797-1 Type1 |
| Coupling dimensions | N/A | N/A |
| Hose connections | N/A | N/A |
10. Conclusion:
Based on the performance testing results, comparison of technology, and the indications for use, contained in the submission, MICRO-NX Co., Ltd. concludes that the MEG-TORQ is substantially equivalent to the predicate device.