(703 days)
Not Found
No
The description focuses on mechanical measurement and acceleration sensing, with no mention of AI or ML terms, image processing, or data training/testing.
No
The device is used for measuring the stability of implants, which is a diagnostic or monitoring function, not a therapeutic intervention.
Yes
The device measures the stability of implants, which is a form of diagnosis to assess the condition of the implant.
No
The device description explicitly mentions "mechanically striking the implanted abutment" and using an "acceleration sensor mounted on the Attack Pole," indicating the presence of physical hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Trust device measures the mechanical stability of implants by physically interacting with the implant and bone. It does not analyze biological samples taken from the patient.
- Intended Use: The intended use is to measure the stability of implants, which is a mechanical assessment, not a diagnostic test performed on a biological sample.
Therefore, the Trust device falls outside the scope of In Vitro Diagnostics. It is a medical device used for a mechanical assessment of implant stability.
N/A
Intended Use / Indications for Use
The Trust is indicated for use in measuring the stability of implants in the oral cavity and maxillofacial region. The Trust is restricted to usage with Dentium implant system, and the angle of the abutment must be maintained at 90° when in use.
Product codes
EKX
Device Description
This equipment measures the time between the healing abutment and the striking rod by mechanically striking the implanted abutment and quantifies the fluctuation between the implant abutment and the alveolar bone. It is a principle to measure the contact time according to the acceleration change at the moment of being hit by using the acceleration sensor mounted on the Attack Pole. The higher the number, the better the fixation between the implant fixture and the bone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Implant or Abutment
Root canal, Softened dentin
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)
All test results show that the materials, manufacturing processes and design used in The Trust met established specifications required for consistent performance for the intended use. Additionally, performance comparison tests with already licensed products confirm that the two products have similar performance (refer to 002 Equivalence test to AnyCheck). Therefore, there is no effect on the safety or effectiveness of this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Error of measurement value: +/-3 ISV
Tapping Strength, Times: Under 3N, 7 times, 0.3 sec / 1 time
Predicate Device(s)
Reference Device(s)
Not Found
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
August 9, 2024
Genoss Co., Ltd Jiyeon Lee RA staff 1F, Gyeonggi R&DB Center, 105 Gwanggyo-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do SOUTH KOREA
Re: K222688
Trade/Device Name: The Trust Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I, reserved Product Code: EKX Dated: July 16, 2024 Received: July 16, 2024
Dear Jiyeon Lee:
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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
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Sincerely,
Michael E. Adjodha -S
Michael E. Adjodha, MChE, RAC, CQIA 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) K222688
Device Name The Trust
Indications for Use (Describe)
The Trust is indicated for use in measuring the stability of implants in the oral cavity and maxillofacial region. The Trust is restricted to usage with Dentium implant system, and the angle of the abutment must be maintained at 90° when in use.
| Type of Use (Select one or both, as applicable) | |
|---|---|
X Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/0 description: The image shows the word "GENOSS" in a stylized font. The letters "GEN" are in a dark green color, while the letters "OSS" are in a lighter green color. The font is bold and sans-serif, with the "O" in "OSS" having a unique design where the top part of the "O" is open and connects to the "S".
510(k) Summary
1. Company
| Submitter | |
|---|---|
| Name | GENOSS Co., Ltd. |
| Address | Head Office: 1F, Gyeonggi R&DB Center, 105 Gwanggyo-ro, Yeongtong-gu, |
| Suwon-si, Gyeonggi-do, Korea | |
| Manufacturing site: D-Factory, 56, Changnyong-daero 256 beon-gil, | |
| Yeongtong-gu, Suwon-si, Gyeonggi-do, Korea | |
| Phone/Fax | +82-70-7098-7573 |
| Contact person | Jiyeon Lee / RA |
| jylee3@genoss.com | |
| Summary Date | 8/6/24 |
2. Device Name
| Proprietary name: | The Trust |
|---|---|
| Regulation description: | Dental Implant stability measuring device |
| Classification name: | Handpiece, Direct Drive, AC-Power |
3. Predicate Device
| K180953 | AnyCheck IMT-100 |
|---|---|
| --------- | ------------------ |
4. Description
This equipment measures the time between the healing abutment and the striking rod by mechanically striking the implanted abutment and quantifies the fluctuation between the implant abutment and the alveolar bone. It is a principle to measure the contact time according to the acceleration change at the moment of being hit by using the acceleration sensor mounted on the Attack Pole. The higher the number, the better the fixation between the implant fixture and the bone.
5. Indication for use
The Trust is indicated for use in measuring the stability of implants in the oral cavity and maxillofacial region. The Trust is restricted to usage with Dentium implant system, and the angle of the Attack Pole to the abutment must be maintained at 90° when in use.
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Image /page/5/Picture/0 description: The image shows the word "GENOSS" in a stylized font. The first three letters, "GEN", are in a dark green color, while the last three letters, "OSS", are in a lighter, lime green color. The font is bold and sans-serif, with a slightly rounded appearance. The letters are closely spaced, giving the word a compact and unified look.
6. Comparison Technological Characteristics with the Predicate Devices
The Trust was compared to the predicate device, Anycheck IMT-100, from a technical, and biological perspective. The comparison of the predicate device to the subject device does not raise any new questions of safety and effectiveness. The reasons for this are shown in the table below.
| Device name | The Trust | AnyCheck IMT-100 | |
|---|---|---|---|
| Manufacture | Genoss Co., Ltd. | DMS Co., Ltd. | |
| 510(K) Number | New device | K180953 | |
| Classification | Class I | Class I | |
| Regulation | |||
| Number | 21 CFR 872.4200 | 21 CFR 872.4200 | |
| Classification | |||
| Product Code | EKX | EKX | |
| Clinical | Target population | Human Tooth | Human Tooth |
| Indication for use | The Trust is restricted to usage with | ||
| Dentium implant system, and the angle of | |||
| the Attack Pole to the abutment must be | |||
| maintained at 90° when in use. | The AnyCheck IMT-100 is | ||
| indicated for use in measuring the | |||
| stability of implants in the oral | |||
| cavity and maxillofacial region | |||
| Performance Property | The Trust measures the time when | ||
| the rod hits the installed implant | |||
| base by mechanically vibration, | |||
| and quantifies the stability of the | |||
| implant. The contact time is the | |||
| principle of measuring the contact | |||
| time according to the change in the | |||
| acceleration of the moment struck | |||
| using the accelerometer mounted | |||
| on the strike rod. The higher the | |||
| number, the implant stability is | |||
| more rigid. | AnyCheck measures the time when | ||
| the rod hits the installed implant | |||
| base by mechanically vibration, | |||
| and quantifies the stability of the | |||
| implant. The contact time is the | |||
| principle of measuring the contact | |||
| time according to the change in the | |||
| acceleration of the moment struck | |||
| using the accelerometer mounted | |||
| on the strike rod. The higher the | |||
| number, the implant stability is | |||
| more rigid. | |||
| Anatomical Location of | |||
| Use | Implant or Abutment | Implant or Abutment | |
| Anatomical Sites | Root canal, Softened dentin | Root canal, Softened dentin | |
| Technical | Error of measurement | ||
| value | ±3 ISV | ±3 IST | |
| Angle deviation | Alarm sounds when out of angle of | ||
| use | |||
| (Setting angle 0~90°) | Alarm sounds when out of angle of | ||
| use | |||
| (Setting angle 0~30°) | |||
| Size and Weight | Instrument size: | ||
| 220 x 25 x 27.5 mm | |||
| Instrument weight: 80g | Instrument size: | ||
| 195 x 31.8 mm | |||
| Instrument weight: 100g | |||
| Electrical Rated | |||
| Voltage/ | |||
| Current | DC 3.7V / 0.5A | DC 5V / 1A | |
| Auto Power off | 120sec (±10%) | 60sec | |
| Tapping Strength, Times | Under 3N | ||
| 7 times | |||
| 0.3 sec / 1 time | Less than 1.3N | ||
| 6 times | |||
| 0.5 sec / 1 time |
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Image /page/6/Picture/0 description: The image shows the word "GENOSS" in a stylized font. The "GEN" part of the word is in a dark green color, while the "OSS" part is in a lighter green color. The letters are bold and slightly rounded, giving the word a modern and professional look. The overall design is clean and simple, making it easily recognizable.
| Biological | Components | Front Housing
Attack Pole
Body – Power and operation
button, LCD window
USB Connector
USB C-type Cable | AnyCheck Main Body
Tapping Rod
Tapping Rod Front Guide
ON/OFF Switch
LCD Display
Target Bar
Tapping Rod Allen Wrench
USB C Type Cable |
|------------|----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Rated Voltage | DV 5V (USB C-Type) | DV 5V (USB C-Type) |
| | Operation Mode | Continuous Operation | Continuous Operation |
| | Display | Power ON display
Operation display
Start Charging display
ISV scale display (199)99),
Operating Error display
Charging error display | ON/OFF display
Operation display
Charging display
IST scale display (0
Error display (Error) |
| | Commands/
Function | Power ON
Measurement
Power OFF | Power ON
Action
Power OFF |
| | Mechanical/ | The Trust is designed and | AnyCheck is designed and |
| | Electrical safety/ | manufactured with applicable | manufactured with applicable |
| | Standards | standards: IEC 60601-1 | standards: IEC 60601-1 |
| | Chemical Safety | Biocompatible | Biocompatible |
| | Cytotoxicity/
Oral mucosa irritation/
Skin sensitization | According to ISO 10993-5
ISO 10993-10
ISO 10993-12 | According to ISO 10993-5
ISO 10993-10
ISO 10993-12 |
| | Sterilization | User sterilization and disinfection | User sterilization and disinfection |
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Image /page/7/Picture/0 description: The image shows the word "GENOSS" in a stylized font. The letters "GENO" are in a dark green color, while the letters "SS" are in a lighter, lime green color. The font is bold and slightly italicized, giving the word a dynamic and modern appearance.
6.1 Gap Analysis
Gap (1): Accessories for measurement of stability
There are differences in the components of the subject device and the predicate device, but those differences do not affect the safety and effectiveness of this product.
-Tapping Rod: The tapping rod of the predicate device is a component that plays the same role as the attack pole of the subject device, and is a component that measures the stability of the implant by tapping the healing abutment.
-Front Guide Tapping Rod: The Front Guide Tapping Rod in the predicate device is a component that guides the movement of the tapping rod to measure implant stability, and the Front Housing in the subject device performs the same role. Therefore, there are no issues with the safety and effectiveness of the product.
Gap (2): Discussion of the similarities
-Technical: Both the predicate and subject devices are utilized on the implant abutment to measure contact duration by striking it, expressing implant stability numerically. These products are deemed equivalent as they operate on the same principle at the same site.
-Biological: Both the predicate and subject devices are medical devices with components that contact the body. Biological evaluation requirements for both products adhere to the FDArecognized ISO 10993 consensus standard, "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing." There are no concerns regarding the safety and effectiveness of the product.
Gap (3): Discussion of the difference
Predicate device has a component called a target bar to ensure the accuracy of measurements. Subject device does not include this component. Instead, we included a calibrator within the subject device. Subject device derives measurement values by calculating the contact time between the abutment and the Attack Pole, but when operating in the air, its movement is stopped by a component called a Collar spacer. Because the attack pole does not touch the object, contact time cannot be calculated. Therefore, the measurement will be 0 and the user can assume that the machine is operating normally. Therefore, if the measured value is displayed as 0 when operating in the air, it is operating normally. In conclusion, a calibrator like the Target Bar on the predicate device is built into the subject device.
In the case of predicate device, the tapping rod and the main body are connected by screwing, so an Allen wrench is used to ensure a firm connection. However, in the case of subject, the Attack Pole and the body are connected by magnets, so there is no need for separate connection parts. This difference in parts does not affect the effectiveness or safety of the product.
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Image /page/8/Picture/0 description: The image shows the word "GENOSS" in a stylized font. The "GEN" part of the word is in dark green, while the "OSS" part is in a lighter, lime green color. The font is bold and slightly italicized, giving the word a dynamic and modern appearance. The overall design is clean and simple, with a focus on the typography.
7. Biocompatibility Data
Biocompatibility testing on the proposed The Trust has been completed. Requirements for biological evaluation of the proposed device were based on FDA recognized concensus standard of ISO 10993, "Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing." The biocompatibility test results show that the materials used in the design and manufacture of the components of the proposed device are non-toxic and non-sensitizing to biological bone and tissues with its intended use.
8. Performance Data
All test results show that the materials, manufacturing processes and design used in The Trust met established specifications required for consistent performance for the intended use. Additionally, performance comparison tests with already licensed products confirm that the two products have similar performance (refer to 002 Equivalence test to AnyCheck). Therefore, there is no effect on the safety or effectiveness of this device.
9. Conclusion
Based on the information provided in this premarket notification of GENOSS Co., Ltd. concluded that comparing the two devices does not raise new questions about safety and effectiveness.