(275 days)
Not Found
No
The summary describes a standard dental unit and chair with basic functionalities like power supply, water/air delivery, and electrical safety. There is no mention of AI, ML, image processing, or any data-driven decision-making processes. The software is described as "moderate" level of concern, which is typical for device control and safety features, not complex AI/ML algorithms.
No.
The device description indicates that the K3 is a "Dental Unit and Chair" designed for "dental treatment," and a "3-way syringe" that aids "the dental application in the mouth of the patient by supplying air, water or spray." While it supports dental procedures, it does not directly treat or cure a disease or condition itself. Its primary function is to provide the necessary environment and tools for dental professionals to perform treatments.
No
The device is described as a "dental treatment unit" and is intended to "supply power to and serve as a base for dental devices and accessories," including a dental chair and a dental instrument (3-way syringe) for supplying air, water, or spray for dental application. Its function is to facilitate dental treatment, not to diagnose a condition.
No
The device description explicitly states it is a "Dental Unit and Chair" and includes hardware components like a dental chair and a 3-way syringe. The performance studies also include testing on physical components like upholstery, waterlines, and the syringe, in addition to software verification and validation.
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," including a dental chair. This is a piece of equipment used during a dental procedure, not for testing samples in vitro (outside the body).
- Device Description: The description confirms it's a "dental treatment unit" and a "dental chair." It also mentions a 3-way syringe for supplying air, water, or spray in the mouth. These are all tools used directly on the patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
- Performance Studies: The performance studies focus on things like biocompatibility, cleaning/sterilization, electrical safety, and software validation – all relevant to a medical device used on a patient, but not to the analytical performance of an IVD.
In summary, the device is a piece of dental equipment used for patient treatment, not for diagnostic testing of samples outside the body.
N/A
Intended Use / Indications for Use
K3 is intended to supply power to and serve as a base for dental devices and accessories. This device includes a dental chair and is intended for use in the dental clinic environment and is designed for use by trained dental professionals, dentists and/or dental assistants.
Product codes (comma separated list FDA assigned to the subject device)
EIA
Device Description
A Dental Unit and Chair K3 (ver 1.2) 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. K3 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 dental professionals, 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: Evaluation for K3 components was conducted in accordance with the FDA Guidance Document and International Standard ISO 10993-1. Upholstery and waterlines were tested for cytotoxicity (ISO 10993-5). Components are considered external communicating devices for less than 24 hours.
- Cleaning and Sterilization Validation: Representative sample of 3-Way syringe components tested to validate withstand steam sterilization and acceptable sterility using recommended protocols. Performed according to ISO 17665-1:2006 and ISO 17665-2. Cleaning/disinfection of waterlines validated using ISO 16954:2015, ISO 19458:2006, and ISO/TS 11080:2009. Microbiological simulation test and physical & chemical test performed to ensure effective cleaning of Dental chair waterline.
- Electrical Safety and Electromagnetic compatibility (EMC): Tests performed in accordance with FDA recognized standards. EMC testing per EN/IEC 60601-1-2. Electrical, mechanical, and environmental safety testing per EN/IEC 60601-1. Usability testing per EN/IEC 60601-1-6 and EN/IEC 62366.
- 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.
Clinical Test Data:
No clinical studies are needed to characterize its performance and establish substantial equivalence.
Key results: Based on the non-clinical test data and comparison, the K3 (ver 1.2) is substantially equivalent to the predicate device.
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.
K3 (K152830)
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
§ 872.6640 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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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
September 4, 2019
Osstem Implant Co., Ltd. % Peter Lee Special Projects Manager Hiossen Inc. 85 Ben Fairless Dr Pennsylvania, Pennsylvania 19030
Re: K183347
Trade/Device Name: K3 Regulation Number: 21 CFR 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: Class I Product Code: EIA Dated: June 5, 2019 Received: June 6, 2019
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 (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
1
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 (QS) 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Michael Adjodha Acting Assistant 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) K183347
Device Name K3
Indications for Use (Describe)
K3 is intended to supply power to and serve as a base for dental devices and accessories. This device includes a dental chair and is intended for use in the dental clinic environment and is designed for use by trained dental professionals, 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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Image /page/3/Picture/0 description: The image shows the logo for Osstem Implant. The logo is in orange and consists of 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 to the right of the word "OSSTEM".
510(k) Summary
Date Summary Prepared: September 3, 2019
I. Company Information
| Submitter: | OSSTEM IMPLANT Co., Ltd.
1st floor, B-dong, 135, Gasan digital 2-ro,
Geumcheon-gu, 08504, Seoul, Korea |
|-----------------------|--------------------------------------------------------------------------------------------------------------|
| Contact Person: | Hyeri Han / Regulatory Affairs Team
Tel.: +82 70 4626 0881
Email: hyerihan@osstem.com |
| Correspondent's Name: | HIOSSEN Inc.
85 Ben Fairless Dr. Fairless Hills, PA 19030
Peter Lee
Tel.: 267 7597031 |
II. Device Information
| Trade/Proprietary Name: | K3 |
|---|---|
| Common/Usual Name: | Unit, Operative Dental |
| Classification Name: | Dental Operative Unit and Accessories (per 21 CFR 872.6640) |
| Product Code: | EIA |
| Device Class: | Class I |
III. Predicate Devices
K3 (K152830)
IV. Product Description
A Dental Unit and Chair K3 (ver 1.2) 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. K3 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.
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Image /page/4/Picture/0 description: The image contains the logo for Osstem Implant. The logo is orange and features the word "OSSTEM" in a stylized font. Below the word "OSSTEM" is the word "IMPLANT" in a smaller, gray font. The logo is simple and modern.
(1) Design Feature
K3, dental operative unit, has features of ergonomic and optimal position for treatment. It consists of adjusted touch panel, 3-way syringe, assistant touch panel, eas y opening and closing armrest.
(2) Main Types
There are a couple of types for this device-K3 Mount and K3 Cart which consists of chair, unit, table, seat, stool, 3-way syringe, monitor arms, fool control and console.
(3) Technological Characteristics
K3 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 and a dental light as offering several additional options and electronically-controlled chair movements with software and water unit functions.
V. Indications for Use
K3 is intended to supply power to and serve as a base for dental devices and accessories. This device includes a dental chair and is intended for use in the dental clinic environment and is designed for use by trained dental professionals, dentists and/or dental as sistants.
VI. Summary of Technological Characteristics
The K3 (ver 1.2) functions in a manner similar to and is intended for the same use to the predicate device. Primarily, K3 (ver 1.2) is substantially equivalent to the K3 (K152830) 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 K3 (ver 1.2) demons trate that the devices are deemed to be substantially equivalent as described in a following comparison table:
| Description | Subject Device | Predicate Device |
|---|---|---|
| Indications for Use | K3 is intended to supply power to and | |
| serve as a base for dental devices and | ||
| accessories. This device includes a | ||
| dental chair and is intended for use | ||
| in the dental clinic | ||
| environment and is designed for use by | ||
| trained dental professionals, | ||
| 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 is 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 | K3 | K3 |
| Version | 1.2 | 1.1 |
| 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 |
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Image /page/5/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. The logo is simple and modern.
TEM IMPLANT Co., Ltd.
1st floor, B-dong, 135, Gasan digital 2-ro, Geumcheon-gu, Seoul, Korea www.osstem.com
| Main Components | Chair, Unit, Table, Seat, Stool,
Monitor Arm*, Hanaro
Console* (Note: K3 Cart* model
applied ONLY) | Chair, Unit, Table, Seat, Stool,
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/offand intensity controlled by foot
pedal. | Uses pneumatically controlled vales to
watercontrol the flow of air and water.
On/offand intensity controlled by foot
pedal. |
| Air Pressure | 500kPa(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 | N/A |
| Suction | HVE (High volume evacuator)
Saliva Ejectors | HVE (High volume evacuator)
Saliva Ejectors |
| Patient Load | Max. 135kg | Max. 135kg |
| Chair Height | Max. 795±10mm, Min. 365±10mm | Max. 790±10mm, Min. 450±10mm |
| Back Rest | 0° ±5° to 67° ±5° | 0° to 66° |
| Head Rest | -10° to 45° | -10° to 45° |
| Lift Motor | Hydraulic electromotor | Hydraulic electromotor |
| Electrical Safety | Complied with IEC 60601-1 | Same as |
| Electromagnetic
compatibility | Complied with IEC 60601-1-2 | Same as |
[Table 1] Comparison between K3 and its predicate device
VII. Principle of Operation
Raising and lowering the dental chair
While the Table Panel or Foot Control's 'Raise' S/W is being operated, the hydraulic motor of the chair operates and the 'Raise' solenoid valve opens, driving the Oil Tank to the 'Raise' Cylinder, hydraulically raising the chair. Similarly, while the "Lower" S/W is being operated, the "Lower' solenoid valve opens, and the weight of the chair moves the Oil from the 'Raise' Cylinder to the Oil Tank, lowering the chair.
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 nbber film of the Master Block. Pressing the controller (Foot Control) Pedal at this time opens the supply air valve inside the air of the compressor is supplied to the removed Hand-Piece through the 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
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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, lighter font. The logo is simple and modern.
OSSTEM IMPLANT Co., Ltd. 1st floor, B-dong, 135, Gasan digital 2-ro, Geumcheon-gu, Seoul, Korea www.osstem.com
Solenoid Valve and supplying air to the suction device to enable suction.
3-Way Syringe
It operates by air pres sure or electronic circuit S/W.
Water Supply System
Upon detection of the cupby 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.
VIII. Non-Clinical Test Data
Biocompatibility Testing
The biocompatibility evaluation for K3 components was conducted in accordance with the FDA Guidance Document and Intemational Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The upholstery, waterlines were tested for cytotoxicity (ISO 10993-5). The components of the K3 are considered external communicating device for a duration of less than 24 hours.
Cleaning and Sterilization Validation
A representative sample of the 3-Way s yringe components were tested to validate that the components can withstand the steamsterilization process and that acceptable sterility is achieved using the recommended sterilization protocols. The sterilization testing was conducted according to ISO 17665-1:2006 and ISO 17665-2 and it validated that thereusable K3 components can be sterilized to reach an acceptable sterility assurance level. In addition, cleaning/disinfection vas conducted on the waterlines of the subject device. Validation was conducted using the following standards:
ISO 16954:2015 Dentistry - Test methods for dental unit waterline biofilmtreatment
ISO 19458:2006 Water quality-Sampling for microbiological analysis
ISO/TS 11080:2009 Dentistry - 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.
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 K3 in accordance FDA recognized standards. EMC testing was conducted in accordance with Standard ENVIEC 60601-1-2. Electrical, mechanical, and environmental safety testing according to Standard ENVIEC 60601-1was performed. Usability testing was conducted in accordance with Standard EN/IEC 60601-1-6 and EN/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
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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. The word "IMPLANT" is written in a smaller, gray font below the main logo. The logo is simple and modern.
OSSTEM IMPLANT Co., Ltd. 1st floor, B-dong, 135, Gasan digital 2-ro, Geumcheon-gu, Seoul, Korea www.osstem.com
Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern.
IX. Clinical TestData
No clinical studies are needed to characterize its performance and establish substantial equivalence.
X. Conclusion
Based upon the above mentioned data and comparison table, the K3 (ver 1.2) is substantially equivalent to the predicate device as described herein.