K3(K183347)
Not Found
No
The description focuses on the mechanical and electrical functions of a dental chair and unit, with no mention of AI/ML terms or capabilities.
No
The device is a dental unit and chair used to supply power and as a base for dental devices, but it does not directly perform any therapeutic action on the patient.
No
The device is a dental treatment unit and chair used to supply power and serve as a base for dental devices. Its function is to facilitate dental applications (supplying air, water, or spray), not to diagnose conditions.
No
The device description explicitly states it is a "Dental Unit and Chair K5" and includes a "3-way syringe," which are physical hardware components. The summary also mentions electrical safety and EMC testing, further indicating a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "supply power to and serve as a base for dental devices and accessories" and includes a "dental chair." This describes a piece of equipment used during a dental procedure, not a device used to examine specimens in vitro (outside the body) to diagnose a condition.
- Device Description: The description focuses on the physical components and function of a dental treatment unit and chair, including a 3-way syringe for delivering air, water, or spray into the mouth. This is consistent with a device used for direct patient treatment.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process that would be performed in vitro for diagnostic purposes.
- Clinical Setting: The device is intended for use in a "dental clinic environment" by "trained dentists and/or dental assistants," which aligns with a device used for direct patient care.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
K5 is intended to supply power to and serve as a base for dental devices and accessories. This product includes a dental chair. The dental treatment unit is intended for use in the dental clinic environment and is used by trained dentists and/or dental assistants.
Product codes
EIA, KLC
Device Description
A Dental Unit and Chair K5 is designed for dental treatment of children and adults. It is a dental treatment unit in accordance with IEC 80601-2-60. The 3-way syringe is a dental instrument in accordance with EN 1639. It aids the dental application in the mouth of the patient by supplying air, water or spray. This product is designed for use in dentistry only and may only be used by trained medical personnel. K5 is similar to other commercially available products based on the intended use, the technology used, the claims, the electrical power and performance characteristics. It is substantially equivalent in design, function and intended use to the predicate device.
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
children and adults
Intended User / Care Setting
trained dentists and/or dental assistants / dental clinic environment
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)
Non-clinical Test Data:
- Biocompatibility Testing: Conducted in accordance with the FDA Guidance Document and International Standard ISO 10993-1. Waterlines and airlines tested for cytotoxicity (ISO 10993-5).
- Cleaning Validation: Conducted on waterlines using standards O 16954:2015 Dentistry - Test methods for dental unit waterline biofilm treatment - Sampling for microbiological analysis. Reprocessing validation conducted per FDA Guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling".
- Electrical Safety and Electromagnetic compatibility (EMC): Performed in accordance with IEC 60601-1-2 (EMC), IEC 60601-1 (Electrical, mechanical, environmental safety), IEC 60601-1-6 and IEC 62366 (Usability testing).
- Software and System Verification and Validation: Conducted as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Software considered a "moderate" level of concern.
No clinical studies are submitted. No clinical studies are needed to characterize its performance and establish substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K3(K183347)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.6640 Dental operative unit and accessories.
(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.
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September 3, 2024
OSSTEM Implant Co., Ltd. Chair Business % Peter Lee Sr. Manager QA/RA Production HIOSSEN Inc. 85 Ben Fairless Dr. Fairless Hills, Pennsylvania 19030
Re: K233805
Trade/Device Name: K5 Regulation Number: 21 CFR 872.6640 Regulation Name: Dental Operative Unit And Accessories Regulatory Class: Class I, reserved Product Code: EIA, KLC Dated: August 14, 2024 Received: August 14, 2024
Dear Peter 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-regulatory
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assistance/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 -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
Submission Number (if known)
| Submission Number (if known) | K233805 |
|---|---|
| Device Name | K5 |
| Indications for Use (Describe) | K5 is intended to supply power to and serve as a base for dental devices and accessories. This product includes a dental chair. The dental treatment unit is intended for use in the dental clinic environment and is used by trained dentists and/or dental assistants. |
| 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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192, Haebong-ro, Danwon-gu, Ansan-si, Gyeonggi-do, 15428, Republic of Korea Tel: +82 2 2016 7000 Fax: +82 2 2016 7001 www.osstem.com
510(k) Summary K233805
Date: September 2, 2024
1. Company and Correspondent making the submission
| - Submitter's Name | : Osstem Implant Co., Ltd. Chiar Business |
|---|---|
| - Address | : 192, Haebong-ro, Danwon-gu, Ansan-si, Gyeonggi-do |
| 15428, Republic of Korea | |
| - Contact | : Mr. Sangyong Lee |
| - Phone | : +82-70-4626-0881 |
| - Correspondent's Name | : Hiossen Inc. |
| - Address | : 85 Ben Fairless Dr. Fairless Hills, PA 19030 |
| - Contact | : Mr. Peter Lee |
| - Phone | : +1-267-759-7031 |
2. Proposed Device
| - Trade or (Proprietary) Name | : K5 |
|---|---|
| - Classification Name | : Dental operative unit and accessories |
| - Regulation Number | : 21 CFR872.6640 |
| - Devce Classification | : Class I |
| - Classification Product Code | : EIA |
3. Predicated Device
- K3(K183347) -
4. Description
- A Dental Unit and Chair K5 is designed for dental treatment of children and adults. It is a dental treatment unit in accordance with IEC 80601-2-60. The 3-way syringe is a dental instrument in accordance with EN 1639. It aids the dental application in the mouth of the patient by supplying air, water or spray. This product is designed for use in dentistry only and may only be used by trained medical personnel. K5 is similar to other commercially available products based on the intended use, the technology used, the claims, the electrical power and performance characteristics. It is substantially equivalent in design, function and intended use to the predicate device.
(1) Design Feature
K5, dental operative unit, has features of ergonomic and optimal position for treatment. It consists of adjusted touch panel, 3-way syringe, assistant touch panel, easy opening
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192, Haebong-ro, Danwon-gu, Ansan-si, Gyeonggi-do, 15428, Republic of Korea Tel: +82 2 2016 7000 Fax: +82 2 2016 7001 www.osstem.com
and closing arm rest.
(2) Main Types
There are a couple of types for this device –K5 Mount and K5 Cart which consists of chair, unit, table, seat, stool, 3-way syringe, monitor arms, fool control and console.
(3) Technological Characteristics
K5 is an AC-powered dental operative unit with accessories, intended to supply power to and serve as a base for other dental devices. It includes a treatment chair, dentist element, assistant element and a dental light as offering several additional options and electronically-controlled chair movements with software and water unit functions.
5. Indication for use
K.5 is intended to supply power to and serve as a base for dental devices and accessories. This product includes a dental chair. The dental treatment unit is intended for use in the dental clinic environment and is used by trained dentists and/or dental assistants.
6. Summary of Technological Characteristics
The K5 functions in a manner similar to and is intended for the same use to the predicate device. Primarily, K5 is substantially equivalent to the K3 (K183347) marketed by OSSTEM IMPLANT Co., Ltd and does have some different technological characteristics and slightly different external design. However, these differences do not raise new concerns of substantial equivalence as the performance data and testing of the K5 demonstrate that the devices are deemed to be substantially equivalent as described in a following comparison table:
| Description | Subject Device | Predicate Device |
|---|---|---|
| Indications for Use | K5 is intended to supply power to | |
| and serve as a base for dental | ||
| devices and accessories. This | ||
| product includes a dental chair. | ||
| The dental treatment unit is | ||
| intended for use in the dental | ||
| clinic environment and is used by | ||
| trained dentists and/or dental | ||
| assistants. | K3 is intended to supply power to | |
| and serve as a base for dental | ||
| devices and accessories. This | ||
| product includes a dental chair. | ||
| The dental treatment unit is | ||
| intended for use in the dental | ||
| clinic environment and is used by | ||
| trained dentists and/or dental | ||
| assistants. | ||
| Product Name | K5 | K3 |
| Code | EIA | EIA |
| Power & Utility | ||
| Supply | AC 100-120/220-240V, | |
| 50/60Hz, compressed air and | ||
| water | AC 100-120/220-240V, | |
| 50/60Hz, compressed air and | ||
| water | ||
| Main Components | Chair, Unit, Table, Seat, Stool, | Chair, Unit, Table, Seat, Stool, |
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Image /page/6/Picture/0 description: The image shows the logo for Osstem Implant. The logo is orange and features the word "OSSTEM" in a bold, sans-serif font. Below the word "OSSTEM" is the word "IMPLANT" in a smaller, italicized font. The logo is simple and modern, and the orange color is eye-catching.
92, Haebong-ro, Danwon-gu, Ansan-si, Gyeonggi-do, 15428, Republic of Korea el: +82 2 2016 7000 Fax: +82 2 2016 7001 www.osstem.com
| Monitor Arm, Hanaro Console | Monitor Arm*, Hanaro Console* (Note: K3 Cart* model applied ONLY) | |
|---|---|---|
| Syringe | 3-way syringe | 3-way syringe |
| Control of water and air | Uses pneumatically controlled vales to water control the flow of air and water. On/off and intensity controlled by foot pedal. | Uses pneumatically controlled vales to water control the flow of air and water. On/off and intensity controlled by foot pedal. |
| Air Pressure | 550kPa(min)/750kPa(max) | 500kPa(min)/750kPa(max) |
| Water Pressure | 250kPa(min)/600 kPa(max) | 250kPa(min)/600 kPa(max) |
| Water System | City water supply | City water supply |
| Water Sanitation System | Distilled water container added | Distilled water container added |
| Suction | HVE (High volume evacuator) Saliva Ejectors | HVE (High volume evacuator) Saliva Ejectors |
| Patient Load | Max. 150kg | Max. 135kg |
| Chair Height | Max. 840±30mm, Min. 440±30mm | Max. 795±10mm, Min. 365±10mm |
| Back Rest | $0°±5°$ to $70°±5°$ | $0°±5°$ to $67°±5°$ |
| Head Rest | -90° to 70° | -10° to 45° |
| Lift Motor | Electromotor | Hydraulic electromotor |
| Electrical Safety | Complied with IEC 60601-1 | Complied with IEC 60601-1 |
| Electromagnetic compatibility | Complied with IEC 60601-1-2 | Complied with IEC 60601-1-2 |
[Table 1] Comparison between K3 and its predicate device
7. Principle of Operation
Raising and lowering the dental chair
The K5 is an electronically controlled, electrically powered chair. The footswitch is used to position the chair and program auto-positioning functions into the chair. The chair hydraulic system is controlled by the electronics using electronic switching components and electrically powered solenoid valves.
Automatic positioning
Operating the 'Automatic' S/W on the Table Panel commands the chair's control device to automatically move and position the chair and seat to a predetermined position.
Hand-Piece Operation Circuit
Micro S/W, closing the supply air valve and opening the rubber film of the Master Block. Pressing the controller (Foot Control) Pedal at this time opens the supply air valve inside the Table, and the air of the compressor is supplied to the removed Hand-Piece through the
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Image /page/7/Picture/0 description: The image shows the logo for Osstem Implant. The logo is orange and features the word "OSSTEM" in a bold, sans-serif font. Below the word "OSSTEM" is the word "IMPLANT" in a smaller, lighter font. There is a small circle in the upper right corner of the logo.
192, Haebong-ro, Danwon-gu, Ansan-si, Gyeonggi-do, 15428, Republic of Korea Tel: +82 2 2016 7000 Fax: +82 2 2016 7001 www.osstem.com
distribution block, thereby rotating the Hand-Piece Turbine. The air used to rotate the Hand-Piece Turbine is discharged to the atmosphere through the exhaust pipe.
Vacuum Operation
Removing the Suction from the Holder activates the Sensor mounted inside the Holder, opening the Air Solenoid Valve and supplying air to the suction device to enable suction.
3-Way Syringe
Pressing the button on the 3-way syringe , water or air is discharged.
Water Supply System
Upon detection of the cup by the Water Supply Port Sensor, PCB's Volume controls water volume.
Water Tube Cleaning
Pressing the Water Supply Button and Film Viewer Button together after supplying 1.2 L of cleaning solution (2~5% of hydrogen peroxide) to the Water Tube Cleaning/Distilled Water Container activates the Water Tube Cleaning System.
8. Non-clinical Test Data
Biocompatibility Testing
The biocompatibility evaluation for K5 components was conducted in accordance with the FDA Guidance Document and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The waterlines and airlines were tested for cytotoxicity (ISO 10993-5). The components of the K5 are considered external communicating device for a duration of less than 24 hours.
Cleaning Validation
Cleaning/disinfection validation was conducted on the waterlines of the subject device. Validation was conducted using the following standards:
O 16954:2015 Dentistry - Test methods for dental unit waterline biofilm treatment -Sampling for microbiological analysis
- Essential characteristics of test methods for the evaluation of treatment methods intended to improve or maintain the microbiological quality of dental unit procedural water. The microbiological simulation test and physical & chemical test are performed to ensure that the Dental chair waterline is effectively cleaned.
Reprocessing validation was conducted per FDA Guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling - Guidance for Industry and Food and Drug Administration Staff (fda.gov)" including cleaning, disinfection, and sterilization validation for the components of the K5 device.
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OSSTEM
IMPLANT
192, Haebong-ro, Danwon-gu, Ansan-si, Gyeonggi-do, 15428, Republic of Korea Tel: +82 2 2016 7000 Fax: +82 2 2016 7001 www.osstem.com
Electrical Safety and Electromagnetic compatibility(EMC)
The Electrical Safety and Electromagnetic compatibility tests were performed in accordance with the following standards. Comprehensive performance testing has been conducted on the K5 in accordance FDA recognized standards. EMC testing was conducted in accordance with Standard IEC 60601-1-2. Electrical, mechanical, and environmental safety testing according to Standard IEC 60601-1was performed. Usability testing was conducted in accordance with Standard IEC 60601-1-6 and IEC 62366.
Software and System Verification and Validation
Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern.
9. Clinical Test Data
No clinical studies are submitted.
No clinical studies are needed to characterize its performance and establish substantial equivalence.
10. Conclusion
Based upon the above mentioned data and comparison table, the K5 is substantially
equivalent to the predicate device as described herein.