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.

Device Description

K3, Dental Unit and Chair, is designed for dental treatment of children and adults. It is a dental treatment unit in accordance with ISO 7494-1, ISO 7494-2 and ISO 6875. The 3way 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 devices.

AI/ML Overview

This FDA 510(k) summary describes the K3 dental unit, which is a dental operative unit and accessories, including a dental chair. The submission aims to establish substantial equivalence to a predicate device, the Sirona C8 (K983242).

Here's the breakdown of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy) that the device must meet for a particular clinical task. Instead, it focuses on demonstrating substantial equivalence to a predicate device by comparing technical specifications, safety standards, and intended use. The "reported device performance" is largely framed within compliance with various international standards and the comparison table.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):

Acceptance Criteria (Inferred)	Reported Device Performance
1. Intended Use Equivalence	K3 is intended to supply power to and serve as a base for dental devices and accessories, including a dental chair, for use in a dental clinic by trained dentists and/or dental assistants. This is compared directly to the predicate device's intended use.
2. Technical Characteristics Equivalence	Power and Utility Supply: AC 100-120/220-240V, 50/60Hz, compressed air and water (Predicate: 110V/220V AC, compressed air and water). Protection Class: Class 1 equipment (Same as predicate). Applied parts: Type B (Same as predicate). Air Pressure: 500kPa(min)/750kPa(max) (Predicate: 550 kPa/750 kPa). Water Pressure: 250kPa(min)/600 kPa(max) (Same as predicate). Water System: City water supply (Predicate: User may select self-contained or city water supply). Patient load: Max. 135kg (Same as predicate). Chair Height: Max. 790±10mm, Min. 450±10mm (Predicate: Max.755mm, Min. 395mm). Back Rest: 0° to 66° (Predicate: 0° to 60°). Head Rest: -10° to 45° (Same as predicate).
3. Electrical Safety Compliance	Complies with IEC 60601-1 (Same as predicate).
4. EMC Compliance	Complies with IEC 60601-1-2, EN55011, EN 61000-3-2, EN 61000-3-3 (Same as predicate on IEC 60601-1-2).
5. Biocompatibility (for contacting components)	Components (upholstery, waterlines, airlines) tested for cytotoxicity (ISO 10993-5) and found acceptable. Considered external communicating device for <24 hours.
6. Cleaning and Sterilization Validation (for relevant parts)	3-Way syringe components tested to validate steam sterilization process and acceptable sterility (ISO 17665-1:2006, ISO 17665-2). Waterlines cleaning/disinfection validated (ISO 16954:2015, ISO 19458:2006, ISO/TS 11080:2009 for microbiological simulation and physical/chemical tests).
7. Software Verification and Validation	Conducted in accordance with FDA guidance for "moderate" level of concern software (ISO 14971, IEC 62304, IEC 60601-1).
8. Usability Engineering	Conducted in accordance with EN/IEC 60601-1-6 and EN/IEC 62366.
9. Mechanical Safety and Performance	Complies with IEC 60601-1, ISO 7494-1, ISO 7494-2, ISO 6875, IEC 80601-2-60. Hydraulic motor durability test to ISO 13485.

Study Details:

This document is a 510(k) summary for a Class I medical device (Dental Operative Unit and Accessories). For such devices, clinical studies and elaborate performance evaluations focusing on diagnostic accuracy (like those for AI/ML devices) are typically not required. The primary mechanism for clearance is demonstrating substantial equivalence to a legally marketed predicate device through non-clinical performance testing and comparison of technical specifications and intended use.

Therefore, many of the requested details about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML device (e.g., sample sizes for test sets, ground truth establishment, MRMC studies) are not applicable to this submission.

Here are the answers based on the provided text, indicating "Not Applicable" where appropriate for this type of device submission:

A table of acceptance criteria and the reported device performance: See the table above based on inferred criteria and the comparison tables in the document.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: Not applicable. The document describes non-clinical engineering and safety compliance testing (e.g., electrical safety, EMC, biocompatibility, sterilization, cleaning validation) rather than testing on a "test set" of patient data as would be used for an AI/ML diagnostic device. These tests are performed on either components or the assembled device.
- Data Provenance: Not applicable. The tests are laboratory-based and standard compliance tests. The manufacturer is Osstem Implant Co. Ltd. from Seoul, Republic of Korea.
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):
- Number of Experts: Not applicable. Ground truth as typically defined for diagnostic performance is not relevant here. Compliance with standards and technical specifications is verified by testing facilities and potentially by internal engineering teams.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication method: Not applicable.
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:
- MRMC Study: No. This is a physical dental unit, not an AI/ML diagnostic or assistive device that would involve human readers.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Standalone Performance: No. This is not an algorithm; it's a dental chair and associated components.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: Not applicable. The "ground truth" here is compliance with established international standards (e.g., IEC, ISO, EN) for safety, electrical characteristics, biocompatibility, cleaning, and sterilization.
The sample size for the training set:
- Sample Size for Training Set: Not applicable. This device does not involve a training set as it is not an AI/ML algorithm.
How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 20, 2017

Osstem Implant Co. Ltd. c/o Mr. David Kim Hiossen Inc. QA/RA Manager 85 Ben Fairless Dr. Fairless Hills, PA 19030

Re: K152830

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: March 7, 2017 Received: March 21, 2017

Dear Mr. David Kim:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Isting 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 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug AdministrationIndications for Use	Form Approved: OMB No. 0910-012Expiration Date: January 31, 2017See PRA Statement below.
510(k) Number (if known)	K152830
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 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:

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information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14)

Page 1 of 1

PSC Publishing Services (301) 443-6740 EF

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st floor, B-dong, 135 Gasan digital 2-ro,Geumcheon-gu, Seoul, Republic of Korea. 153-759

510(k) Summary

Date: April 20, 2017

1. Company and Correspondent making the submission:

Submitter's Name:
Address
Contact :
Phone:
Correspondent's Name:
Address:
Contact:
Phone:

2. Device:

Trade or (Proprietary) Name : Common or usual name : Classification Name : Regulation Number : Device Classification: Subsequent Product Code:

Osstem Implant Co., Ltd. 1st floor, B-dong, 135 Gasan digital 2-ro, Geumcheon-gu, Seoul, Republic of Korea. 153-759 Mr. Kim, Byunghoon +82-70-4394-5157

HIOSSEN Inc. 85 Ben Fairless Dr. Fairless Hills, PA 19030 DAVID KIM 267 759 7031

K3

Dental Unit and Chair Dental operative unit and accessories 21CFR872.6640 Class I EIA

3. Predicate Device:

Sirona C8 (K983242)

4. Description

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Image /page/4/Picture/0 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is in orange, with a small orange circle to the right of the word. Below "OSSTEM" is the word "IMPLANT" in gray. The logo is simple and modern.

1st floor, B-dong, 135 Gasan digital 2-ro,Geumcheon-gu, Seoul, Republic of Korea. 153-759

(1) Design Feature

K3 dental operative unit has features of ergonomic, optimal position for treatment. Adjusted touch panel, 3way syringe and assistant touch panel, easy opening and closing arm rest.

(2) Main component of K3
K3 Mount and K3 Cart consist of the chair, unit, table, seat, stool, 3-way syringe, monitor arm, foot control and console.
(3) Technological Characteristics
K3 is AC powered dental operative units with accessories that are intended to supply power to, and serve as a base for dental device and accessories. Including a treatment chair, the dentist's element, the assistant's element and a dental light, offer several additional options and electronically control chair movements with software and water unit functions.

5. Substantial Equivalence Discussion

The K3 is substantial equivalent to the predicate device (K983242). The following comparison table is presented to demonstrate substantial equivalence.

	Predicate Device	Subject Device
Product Name	Sirona C8	K3
510(k)	K983242	N/A
Manufacturer	Sirona Dental Systems GmbH	OSSTEM IMPLANT Co., Ltd.
Intended use	The Sirona C8 is an electronicallycontrolled dental operative unit withaccessories that are intended tosupply power to, and serve as a basefor dental devices and accessories.	K3 is intended to supply power to andserve as a base for dental devices andaccessories. This product includes a dentalchair. The dental treatment unit is intendedfor use in the dental clinic environmentand is used by trained dentists and/ordental assistants.
Code	EIA	EIA
Power andUtility supply	110V/220V AC electrical supply,compressed air and water	AC 100-120/220-240V, 50/60Hz, compressedair and water
Protection Class	Class 1 equipment	Class 1 equipment
Applied parts	Type B	Type B
Components	Doctors element, assistants element, flexarm, utility center with optionalcuspidor, patient chair, treatment light,	Chair, Unit, Table, Seat, Stool, Chair, Unit,Table, Seat, Stool, Monitor Arm, HanaroConsole

Comparison Table

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Image /page/5/Picture/0 description: The image contains the logo for Osstem Implant. The word "OSSTEM" is in orange, and the word "IMPLANT" is in gray. The logo is simple and modern, and it is likely used to promote the company's dental implant products.

1st floor, B-dong, 135 Gasan digital 2-ro,Geumcheon-gu, Seoul, Republic of Korea. 153-759

	floor box.	(*K3 Cart model applied)
Installation	Available with chair mounted and cartmounted dentist element Installed bytrained technicians.	Same as
Syringe	3-way syringe /Sprayvit	3-way syringe
Curing light	Mini LED	N/A
Control of Airand water	Uses pneumatically controlled vales toWater control the flow of air and water.On/off and intensity controlled by footpedal.	Same as
Air Pressure	550 kPa/750 kPa (min/max)	500kPa(min)/750kPa(max)
WaterPressure	250 kPa/600 kPa(min/max)	250kPa(min)/600 kPa(max)
Water System	User may select self-Contained watersystem or city water supply	City water supply
Suctiondevices	HVE (High volumeevacuator)Saliva Ejectors	HVE (High volume evacuator)Saliva Ejectors
Patient load	Max. 135kg	Same as
Chair Height	Max.755mmMin. 395mm	Max. 790±10mmMin. 450±10mm
Back Rest	0° to 60°	0° to 66°
Head Rest	-10° to 45°	-10° to 45°
LiftMotor	Motor SL (electricmotor)	Hydraulic electromotor
ElectricalSafety	Comply with IEC 60601-1	Same as
EMC	Comply with IEC 60601-1-2	Same as
Place of Use	Dental office, hospital	Same as
IntendedUsers	Dentists, Dental Hygienists, DentalEquivalent Assistants	Same as

As shown in the comparison chart for K3 of OSSTEM IMPLANT Co., Ltd., predicate device, they are substantially equivalent in terms of indication for use, technology and performance specifications. The external design of the subject device might be slightly different from the subject devices, however, the performance testing results provided in this submission supports that the subject device performs as well as the predicate devices for its intended use.

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1st floor, B-dong, 135 Gasan digital 2-ro,Geumcheon-gu, Seoul, Republic of Korea. 153-759

6. Indication for use

7. Summary of Non-Clinical Performance Testing

The K3 has been subjected to extensive safety, performance, and product validations prior to release. Tests including EMC have been performed to ensure the devices comply with the US regulations.

Biocompatibility Testing

The biocompatibility evaluation for K3 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 upholstery, waterlines, and airlines 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 the3-Way syringe components were tested to validate that the components can withstand the steam sterilization 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 the reusable K3 components can be sterilized to reach an acceptable sterility assurance level.

In addition, cleaning/disinfection was 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 biofilm treatment
· 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)

Comprehensive performance testing has been conducted on the K3 in accordance FDA recognized standards. EMC testing was conducted in accordance with Standard EN/IEC 60601-1-2. Electrical, mechanical, and environmental safety testing according to Standard EN/EC 60601-1 was performed. Usability testing was conducted in accordance with Standard EN/EC 60601-1-6 and EN/IEC 62366.

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Image /page/7/Picture/0 description: The image shows the logo and address of OSSTEM Implant Co., Ltd. The logo features the word "OSSTEM" in orange, with the word "IMPLANT" in gray below it. The address is listed as 1st floor, B-dong, 135 Gasan digital 2-ro, Geumcheon-gu, Seoul, Republic of Korea. The postal code is 153-759.

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.

No.	Test Item	Standard
1	Cytotoxicity	ISO 10993-5
2	EMC Test	EN 60601-1-2 , EN55011 , EN 61000-3-2EN 61000-3-3
3	Software Validation	ISO 14971 , IEC62304 , IEC60601-1
4	Basic safety & essential performance	IEC 60601-1
5	General requirement & test method	ISO 7494-1
6	Air, Water, suction & wastewatersystem	ISO 7494-2
7	Dentistry-Patient chair	ISO 6875
8	Basic safety & essential performanceof dental equipment	IEC 80 601-2-60
9	Collateral Standard : Usability	IEC 60601-1
10	Usability engineering	IEC 62366
11	Hydraulic motor durability test	ISO 13485
12	Dental Hand piece	ISO 15606
13	Cleaning Validation	ISO 16954 , ISO 19458 , ISO/TS 11080 ,ASTM E2871*12
14	Sterilization Validation	ISO 17665-1, ISO/TS 17665-2

8. Summary of clinical testing

No clinical studies are submitted

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Image /page/8/Picture/0 description: The image shows the logo for OSSTEM IMPLANT. The word "OSSTEM" is in orange, and the word "IMPLANT" is in gray. The logo is simple and modern.

1st floor, B-dong, 135 Gasan digital 2-ro,Geumcheon-gu, Seoul, Republic of Korea. 153-759

9. Review

The K3 has the similar device characteristics as the predicate device ; intended use, Power and Utility supply, Syringe, design and use concept are similar. The K3 has a slight difference in components of unit except for curing light. The K3 has been subjected to extensive safety, performance, and product validations prior to release. Safety tests including EMC have been performed to ensure the devices comply with the US regulations. Based on the comparison of intended use and technical features, the K3 is substantial equivalent to the predicate devices.

9. Conclusions

In accordance with the above data and based on the information provided in this premarket notification OSSTEM IMPLANT Co., Ltd. concludes that the K3 is substantially equivalent to predicate devices as described herein.

END

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.