iCTmotor (WL-1)

K193341 · Dentium Co., Ltd. · EBW · Sep 4, 2020 · Dental

Device Facts

• Record ID: K193341
• Device Name: iCTmotor (WL-1)
• Applicant: Dentium Co., Ltd.
• Product Code: EBW · Dental
• Decision Date: Sep 4, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

iCTmotor (WL-1) is intended for use in dental surgery and implantology. The main control unit is designed to operate a specific dental micro motor that drives dental handpieces to cut hard and soft tissues in the mouth and screw dental implants. iCTmotor (WL-1) is compatible with a handpiece equipped with connection according to ISO 3964.

Device Story

iCTmotor (WL-1) is a software-driven dental micromotor control system for implantology and surgery. Input: user-programmed parameters via wireless foot pedal. Transformation: main control unit regulates speed and torque of a micromotor to drive ISO 3964-compliant handpieces. Output: mechanical rotation for cutting tissue and implant placement. Used in dental clinics by dental professionals. Benefits: provides controlled, programmable motor operation for surgical procedures. Healthcare providers use the system to manage surgical parameters, directly affecting the precision of tissue cutting and implant insertion.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via non-clinical bench testing, including electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), software validation, reprocessing validation, and performance testing (ISO 14457:2012) for speed, torque, and irrigation.

Technological Characteristics

Main control unit with wireless foot pedal, micromotor, and cable. Materials: Stainless Steel (SUS 304). Power: 100-240V. Motor: Surgical collector type, 36 VDC, 400-40,000 rpm. Connectivity: Wireless foot pedal (2.405-2.480 GHz). Sterilization: Sterilizable components. Software: Embedded control logic.

Indications for Use

Indicated for use in dental surgery and implantology for cutting hard and soft oral tissues and screwing dental implants. Compatible with ISO 3964-compliant handpieces.

Regulatory Classification

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.

Predicate Devices

• MASTERsurg / EXPERTsurg (K140308)

Submission Summary (Full Text)

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September 4, 2020

Dentium Co., Ltd % Dave Kim Medical Device Regulatory Affairs Mtech Group 7707 Fannin St. Ste 200, V111 Houston, Texas 77054

Re: K193341

Trade/Device Name: iCTmotor (WL-1) Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I. reserved Product Code: EBW Dated: September 3, 2020 Received: September 3, 2020

Dear Dave Kim:

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.

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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 (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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

For Srinivas "Nandu" Nandkumar 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

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# Indications for Use

510(k) Number (if known) K193341

Device Name iCTmotor (WL-1)

### Indications for Use (Describe)

iCTmotor (WL-1) is intended for use in dental surgery and implantology. The main control unit is designed to operate a specific dental micro motor that drives dental handpieces to cut hard and soft tissues in the mouth and screw dental implants. iCTmotor (WL-1) is compatible with a handpiece equipped with connection according to ISO 3964.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

| <div><span style="font-size: 10pt;"> <input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</span></div> |
|-------------------------------------------------------------------------------------------------------------------------|
| <div><span style="font-size: 10pt;"><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</span></div> |

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# 510(k) Summary K193341

This summary of 510(k) information is being submitted in accordance with requirements of 21 CFR Part 807.92.

#### Date 510k summary prepared: September 2, 2020

#### I. SUBMITTER

| Submitter's Name | Dentium Co., Ltd (ICT Branch) |
|------------------------|---------------------------------------------------------------------------------------------|
| Submitter's Address | 76, Changnyong-daero 256beon-gil, Yeongtong-gu<br>Suwon-si, Gyeonggi-do, Korea (Zip. 16229) |
| Submitter's Telephone | [phone] |
| Contact person | Sangwoo Lee / RA Manager<br>[e-mail] |
| Official Correspondent | Dave Kim ([e-mail]) |
| Address | Mtech Group<br>7707 Fannin St. Ste 200-V111<br>Houston, TX 77054 |
| Telephone | [phone] |

#### II. DEVICE

| Trade/proprietary Name | iCTmotor (WL-1) |
|------------------------|---------------------------------------|
| Common Name | Controller, Foot, Handpieces and Cord |
| Regulation Name | Dental Handpieces and Accessories |
| Regulation Number | 21 CFR 872.4200 |
| Product Code | EBW |
| Regulatory Class | Class I |

#### PRIMARY PREDICATE DEVICE (K140308) III.

| Primary Manufacturer | Kaltenbach & Voigt GmbH |
|----------------------|---------------------------------------|
| Device Name | MASTERsurg / EXPERTsurg |
| Common Name | Controller, Foot, Handpieces and Cord |
| Regulation Name | Dental Handpieces and Accessories |
| Regulation Number | 21 CFR 872.4200 |
| Product Code | EBW, EGS |
| Regulatory Class | Class I |

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#### IV. DEVICE DESCRIPTION

iCTmotor (WL-1) is a software based driving engine that controls the speed of a specific dental micromotor. This device is optimized for dental implant procedures and user programmable parameters operate and control a dental handpiece for dental implant surgery. iCTmotor (WL-1) consists of a main controller unit, a charger, a foot controller, micro motor, cable, a water holder, tube holder, and micro motor holder. The main control unit operates the speed and torque of a dental micromotor that drives dental handpiece to cut tissues in the mouth and to screw dental implants. The main control unit is operated via a wireless foot pedal. The holders are used for placement of a water bag, a micro motor and a handpiece. The power cord delivers electric power to the main control unit.

#### V. INDICATIONS FOR USE:

iCTmotor (WL-1) is intended for use in dental surgery and implantology. The main control unit is designed to operate a specific dental micro motor that drives dental handpieces to cut hard and soft tissues and screw dental implants. iCTmotor (WL-1) is compatible with a handpiece equipped with connection according to ISO 3964.

| Device name | iCTmotor (WL-1) | EXPERTsurg + INTRA LUXS600 LED | Remarks |
|-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| 510K Number | K193341 | K140308 | |
| Main body image | Image: iCTmotor (WL-1) | Image: EXPERTsurg + INTRA LUXS600 LED | |
| | | | |
| Foot switch image | Image: Foot switch | Image: Wireless type | Wireless<br>type (same) |
| Micromotor | Image: Micromotor | Image: Micromotor | Similar |
| Indication for use | iCTmotor (WL-1) is intended<br>for use in dental surgery and<br>implantology. The main control<br>unit is designed to operate a<br>specific dental micro motor that<br>drives dental handpieces to cut<br>hard and soft tissues in the<br>mouth and screw dental<br>implants. iCTmotor (WL-1) is<br>compatible with a handpiece<br>equipped with connection<br>according to ISO 3964. | Unit: This KaVo product is intended<br>for surgery to expose and dissect oral<br>tissue structures or endodontic<br>treatments (e.g. periodontal gap,<br>gingiva, bone, aw, extractions and<br>implantations). Motor: The medical<br>device is intended to drive / operate<br>a dental handpiece / contra-angle<br>handpiece equipped with a<br>handpiece connection according to<br>ISO 3964. This medical device is an<br>electrical low-voltage motor for<br>dental purposes according to ISO<br>11498 type 2 and classified as a type<br>B application part. | Similar |
| Compliance to<br>Standards | Handpiece in compliance with<br>ISO 3964 | Handpiece in compliance with ISO | Same |
| Dimensions | 278 x 175 x 134 (mm) | 265 x 255 x 100 mm | Similar |
| Electrical<br>Specification | 100 – 240 V | 100 – 240 V | Same |
| Main Weight | 3kg | 2.0kg | Similar |
| Foot Weight | 0.7kg | 1.1kg | Similar |
| Motor | 135g | 125g | Similar |
| Max output power | Max 70W | Max 150W | Different |
| Motor Type | Surgical Motor (Collector) | Surgical Motor (Collector) | Same |
| Handpiece<br>Connection | INTRAmatic Coupling System<br>(ISO 3964) | INTRAmatic Coupling System<br>(ISO 3964) | Same |
| Electrical<br>Specification<br>Motor (Voltage) | 36 VDC | 22 V AC | Different |
| Electrical<br>Specification<br>Motor (20:1<br>Torque) | 70Ncm | 55 Ncm | Different |
| Electrical<br>Specification<br>Motor (Torque) | 2.3mNm | 5.5Ncm | Different |
| Micro motor LED<br>Input Voltage | DC 3.3V | DC 3.0-3.6V | Similar |
| Micro motor LED<br>Input<br>Current(Max) | 150mA | 150mA | Same |
| Electrical<br>Specification<br>Motor (Rotation) | Clockwise, Counter Clockwise | Clockwise, Counter Clockwise | Same |
| Electrical<br>Specification<br>Motor (Speed) | 400- 40,000rpm | 300 - 40,000 rpm | Similar |
| Pump Delivery<br>rate | 40-60ml/min | 30-110ml/min | Different |
| Handpiece<br>rotational speed<br>(20:1 ratio) | 20 ~ 2,000 rpm | 15 ~ 2,000 rpm | Similar |
| Wireless foot<br>Emitted power | Max 8.6dBm(e.i.r.p.) | Max 3dBm(e.i.r.p.) | Different |
| Wireless foot<br>Frequency bend | 2.405~2.480GHZ | 2.4GHZ | Similar |
| Length of motor<br>cable | 2m | 2m | Same |
| Operating mode | 3min ON/10min OFF | 30sec. of operation/9min.pause | Different |
| Handpiece gearing 20:1<br>ratio | 20:1 | | Same |
| Sterilization | Sterilizable | Sterilizable | Same |
| Storage<br>Ambient<br>temperature | 0°C-+60°C | -20°C-+50°C | Different |
| Operating<br>Ambient<br>temperature | 10°C-+35°C | 10°C-+35°C | Same |
| Storage<br>Relative humidity | Max 90% | 5%-95% | Similar |
| Operating<br>Relative humidity | Max 80% | 15%-80% | Similar |
| Atmospheric<br>pressure Range | 700hPa-1,060hpa | 700hPa-1,060hpa | Same |
| Foot switch<br>control | - Speed key<br>- Program key<br>- Motor | - Direction of motor rotation key<br>- Speed key<br>- Program key<br>- Pump key | Similar |
| Electrical<br>Specification<br>Motor (Speed) | Up to 40,000rpm | Up to 40,000 rpm | Same |
| Handpiece<br>rotational speed | 20 ~ 2,000 rpm | 15 ~ 2,000 rpm | Similar |
| Handpiece gearing | 20:1 | 20:1 | Same |
| Sterilization | Sterilizable | Sterilizable | Same |

#### VI. PREDICATE COMPARISON

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K193341

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### K193341

The proposed iCTmotor (WL-1) is similar in the indications for use, overall design and function to the EXPERTsurg + INTRA LUXS600 LED (K140308). Both the proposed subject device and the primary predicate device consist of a control unit with a micromotor, connecting cable and a wireless foot pedal.

The subject device does not include a straight or contra angle handpiece. An irrigation tube is not included neither.

ICTmotor(WL-1) motor is compatible with any contra-angle handpiece in compliance with EN ISO 3964:2016 and ICTmotor (WL-1) motor is also compatible with irrigation tubes in compliance with EN ISO 7405

The differences do not render the device NSE because the performance tests demonstrate that the differences in technological characteristics do not raise new safety concerns.

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#### VII. SUMMARY OF NON-CLINICAL TESTS

iCTmotor (WL-1) complies with voluntary standards for electrical safety, EMC testing, and use in the dental clinic. The following data were provided to support the substantial equivalence determination:

Electrical Safety:

Testing was conducted in accordance with IEC 60601-1:2012 Medical electrical equipment, Part 1: General requirements for basic safety and essential performance

Electromagnetic Compatibility:

Testing was conducted in accordance with IEC 60601-1-2:2015 Medical Electrical Equipment -Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests

### Software:

Software verification and validation testing as recommended in FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." (May 11, 2005)

### Reprocessing:

Cleaning and sterilization validation test report subject to "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" (March 17, 2015) are provided.

### Biocompatibility:

The subject device is not in direct contact with a patient's skin. The user is instructed to wear gloves while operating the iCTmotor (WL-1). Therefore, biocompatibility test is not considered.

The manufacturer also provided a material/chemical composition and manufacturing based rationale as to how your final finished device is substantially equivalent to the identified primary predicate device:

"The [Stainless Steel: SUS 304] of iCTmotor (K193341) in its final finished form is identical to the [Stainless Steel: SUS 304] of other micro motor manufactured by Maxon motor ag and marketed in the US in formulation, processing, sterilization, and geometry, and no other chemicals have been added (e.g., plasticizers, fillers, additives, cleaning agents, mold release agents)."

" iCTmotor micro motor in its final finished form is identical to other micro motor manufactured by Maxon motor ag and marketed in the US as private labels in formulation, processing, sterilization, and geometry and no other chemicals have been added (e.g., plasticizers, fillers, additives, cleaning agents, mold release agents)."

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### K193341

Performance testing was conducted cording to ISO 14457:2012 to show that the device meets its design requirements and performs as intended. The specifications were met for:

- Rotating speed of micromotor
- . Torque of micromotor
- Stop of micromotor
- . Rotating direction of micro motor
- Irrigation amount

## VIII. SUMMARY OF CLINICAL TESTS

Clinical testing was not required to demonstrate the substantial equivalence of iCTmotor (WL-1) to its predicate device.

#### CONCLUSIONS IX.

Based on the information above, iCTmotor (WL-1) is substantially equivalent to the predicate device. Based on the performance testing results including the nonclinical tests, the subject device is as safe, as effective, and performs as well as or better than the legally marketed device predicate (21 CFR 807.92(b)(3))