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.

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a dental operative unit and accessories (device K3, version 1.2). The submission aims to establish substantial equivalence to a predicate device (K3, version 1.1).

It is important to note that this document does not describe acceptance criteria or a study proving the device meets those criteria in the typical sense of a diagnostic or AI-powered medical device. The K3 is a physical dental unit, not an AI or diagnostic device that would have performance metrics like sensitivity, specificity, or image analysis accuracy.

Instead, the document details non-clinical tests performed to demonstrate that K3 (ver 1.2) is safe and effective and substantially equivalent to its predicate. These tests focus on aspects like biocompatibility, cleaning/sterilization validation, electrical safety, electromagnetic compatibility, and software verification/validation.

Therefore, many of the requested points regarding acceptance criteria and studies (especially those related to AI, ground truth, expert readers, and sample sizes for diagnostic performance) are not applicable to this type of device submission.

Here's a breakdown of the relevant information from the document:

1. A table of acceptance criteria and the reported device performance

Since this is a physical dental operative unit, the "acceptance criteria" are compliance with various safety and performance standards rather than diagnostic accuracy metrics. The "reported device performance" is the conclusion that the device complies with these standards.

Acceptance Criterion (Standard Compliance)	Reported Device Performance (Conclusion of Compliance)
Biocompatibility (ISO 10993-1, ISO 10993-5)	Components (upholstery, waterlines) tested for cytotoxicity and deemed compliant.
Cleaning and Sterilization (ISO 17665-1:2006, ISO 17665-2, ISO 16954:2015, ISO 19458:2006, ISO/TS 11080:2009)	3-Way syringe components can withstand steam sterilization and achieve acceptable sterility. Waterlines validated for effective cleaning via microbiological simulation and physical & chemical tests.
Electrical Safety (EN/IEC 60601-1)	Complied with the standard.
Electromagnetic Compatibility (EMC) (EN/IEC 60601-1-2)	Complied with the standard.
Usability (EN/IEC 60601-1-6, EN/IEC 62366)	Usability testing was conducted in accordance with the standards.
Software Verification and Validation (FDA Guidance for Software in Medical Devices)	Software verification and validation testing were conducted; considered "moderate" level of concern.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified for each test, but general statements like "Components of the K3" and "A representative sample of the 3-Way syringe components" are used. For standards compliance, the "sample" is typically the device itself or representative parts/units of the device.
Data Provenance: The tests would have been performed by the manufacturer (OSSTEM IMPLANT Co., Ltd. located in Seoul, Korea) or accredited testing facilities on behalf of the manufacturer. The data is prospective in the sense that these tests were conducted specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. This is a physical dental unit, not a diagnostic device requiring expert interpretation of results to establish ground truth. Compliance with engineering, safety, and sterilization standards is assessed by qualified engineers and microbiologists, not medical experts establishing a "ground truth" for a medical condition.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. As there's no ground truth established by human experts in the context of diagnostic performance, no adjudication method is relevant. Compliance with standards is typically a pass/fail determination based on objective measurements and testing protocols.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This is not an AI-powered or diagnostic device. No such study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is a physical dental operative unit. It does not have a standalone algorithm for diagnostic performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not Applicable in the traditional diagnostic sense. The "ground truth" for this device is the established safety and performance requirements codified in the cited international and national standards (e.g., IEC 60601-1, ISO 10993-1). The tests aim to demonstrate that the device's characteristics (e.g., electrical leakage, sterilization efficacy, material cytotoxicity) meet the predefined "truth" of these standards.

8. The sample size for the training set

Not Applicable. This is not a machine learning or AI device that requires a "training set."

9. How the ground truth for the training set was established

Not Applicable. As there is no training set.

Summary

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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

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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)

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 TeamTel.: +82 70 4626 0881Email: hyerihan@osstem.com
Correspondent's Name:	HIOSSEN Inc.85 Ben Fairless Dr. Fairless Hills, PA 19030Peter LeeTel.: 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

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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

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 andserve as a base for dental devices andaccessories. This device includes adental chair and is intended for usein the dental clinicenvironment and is designed for use bytrained dental professionals,dentists and/or dental assistants.	K3 is intended to supply power to andserve as a base for dental devices andaccessories. This product includes adental chair is the dental treatment unitis intended for use in the dental clinicenvironment and isused by traineddentists and/or dentalassistants.
Product Name	K3	K3
Version	1.2	1.1
Code	EIA	EIA
Power & Utility Supply	AC 100-120/220-240V,50/60Hz, compressedair and water	AC 100-120/220-240V,50/60Hz, compressedair 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, HanaroConsole (Note: K3 Cart* modelapplied ONLY)	Chair, Unit, Table, Seat, Stool,Monitor Arm, HanaroConsole (Note: K3 Cart* modelapplied ONLY)
Syringe	3-way syringe	3-way syringe
Control of water and air	Uses pneumatically controlled vales towater control the flow of air and water.On/offand intensity controlled by footpedal.	Uses pneumatically controlled vales towatercontrol the flow of air and water.On/offand intensity controlled by footpedal.
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 SanitationSystem	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
Electromagneticcompatibility	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.

Regulation Number and Section

§ 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.