K5 is intended to supply power to and serve as a base for dental devices and accessories. This product is intended for use by dentist and dental assistance to assist dental treatment of patients for adjusting the position of the patient seat, operating the instruments, and supplying water into the oral cavity through a water line in dental clinical environments.

Device Description

The K5 Cart, K5 Mount and K5 Swing are designed for dental treatment and are intended for dental use only and are intended for use by trained medical personnel only.

These devices consist of a foot controller, headrest, backrest, seat, armrest, doctor table, unit, dental light, auxiliary table and doctor stool.

These are 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.

AI/ML Overview

The provided FDA 510(k) clearance letter and summary for the K5 Cart, K5 Mount, K5 Swing devices (K251491) indicate that these devices are Class I Dental Operative Units and Accessories. Class I devices are generally considered to be low-risk and often demonstrate substantial equivalence through non-clinical testing rather than extensive clinical studies.

The document extensively compares the proposed devices to a predicate device (K5, K233805) to establish substantial equivalence. It does not describe specific acceptance criteria in terms of performance metrics with numerical thresholds for the device's function as a whole. Instead, it relies on compliance with recognized consensus standards and a detailed comparison of technological characteristics.

Therefore, many of the requested details about acceptance criteria for device performance (e.g., accuracy, sensitivity, specificity, or improvement over human readers) are not applicable or not explicitly stated in this type of 510(k) submission for a Class I mechanical device. The "acceptance criteria" here are primarily met by demonstrating compliance with safety and performance standards relevant to dental operative units and showing that any differences from the predicate device do not raise new questions of safety or effectiveness.

Here's an analysis based on the provided document, addressing the points where information is available and noting where it's not applicable for this type of device and submission.

Acceptance Criteria and Device Performance

As a Class I dental operative unit, the "acceptance criteria" are primarily established by compliance with recognized electrical safety, electromagnetic compatibility, and performance standards for dental equipment, along with demonstrating that any differences from a predicate device do not introduce new safety or effectiveness concerns. The performance is assessed qualitatively through compliance with these standards and by direct comparison of functionalities and specifications with the predicate device.

Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicit via Standards Compliance)	Reported Device Performance (as demonstrated by compliance/comparison)
Electrical Safety	Compliance with IEC 60601-1	Verified according to IEC 60601-1; electrical safety is equivalent to predicate device.
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2	Verified according to IEC 60601-1-2; EMC is equivalent to predicate device.
Performance (General Dental Unit)	Compliance with ISO 7494-1 (dental units), ISO 7494-2 (dental chairs)	Verified according to ISO 7494-1, ISO 7494-2; performance is equivalent to predicate device.
Software Verification & Validation	Compliance with IEC 62304 and FDA Guidance "Content of Premarket Submissions for Device Software Functions"	Updated software verified according to IEC 62304 and FDA Guidance; deemed substantially equivalent despite different software versions, as major functions are identical.
Air Pressure Parameters	Min/Max Operating Air Pressure Range	Proposed: 550(min), 600kPa(max) (Different from Predicate: 550(min), 750kPa(max). No explicit "acceptance criteria" stated on this difference other than it does not raise new concerns.)
Water Pressure Parameters	Min/Max Operating Water Pressure Range	Proposed: 250(min), 600kPa(max) (Same as Predicate)
Patient Load Capacity	Maximum patient weight	Max. 150kg (Same as Predicate)
Chair Height Adjustment	Min/Max Chair Height	Proposed: Max. 850±30mm, Min. 450±30mm (Different from Predicate: Max. 840±30mm, Min. 440±30mm. No explicit "acceptance criteria" stated.)
Back Rest Angle	Range of backrest articulation	0°±5° to 70°±5° (Same as Predicate)
Head Rest Angle	Range of headrest articulation	Proposed: -90° to 75° (Different from Predicate: -90° to 70°. No explicit "acceptance criteria" stated.)

Study Details

It's important to differentiate that this 510(k) submission is for a mechanical/electrical dental operative unit, not an AI/software as a medical device (SaMD). Therefore, many of the questions related to AI performance metrics, clinical study design for accuracy/sensitivity, expert readers, and ground truth establishment (common for imaging AI) do not apply to this clearance. The "study" here is primarily a series of non-clinical tests and a detailed comparison to a predicate device.

1. Sample sizes used for the test set and the data provenance:

Test Set Sample Size: Not applicable in the context of typical AI/imaging studies. Performance was demonstrated through compliance with recognized standards (IEC 60601-1, IEC 60601-1-2, IEC 80601-2-60, IEC 60601-1-6, ISO 7494-1, ISO 7494-2) and direct engineering measurements and comparisons. This involved testing the physical device(s).
Data Provenance: Not applicable in the sense of patient data. The testing involves engineering and safety evaluations of the manufactured devices.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. The device is a dental operative unit, not an AI diagnostic tool requiring expert-established ground truth from medical images. Compliance with engineering standards and functional specifications constitutes the "ground truth" for this device type.

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

Not applicable. This is not a study involving human reader adjudication of diagnostic outputs.

4. 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 diagnostic or assistive device for human readers.

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

Not applicable, as it's not an algorithm-based device in the diagnostic sense. The device performs its intended functions independently (e.g., moving chair, supplying water/air, powering instruments).

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

For this device, "ground truth" is established by:
- Compliance with recognized consensus standards: e.g., IEC 60601-1 (Electrical Safety), IEC 60601-1-2 (EMC), ISO 7494-1 (Dental Units), ISO 7494-2 (Dental Chairs).
- Engineering specifications and measurements: Verifying that the device meets its design specifications for things like air pressure, water pressure, chair movement ranges, and patient load.

7. The sample size for the training set:

Not applicable. This is not a machine learning/AI device requiring a training set.

8. How the ground truth for the training set was established:

Not applicable. No training set is used.

Summary

FDA 510(k) Clearance Letter - K251491

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.00

July 17, 2025

Osstem Implant Company., Ltd. Chair Business
℅ Leszczak Mateusz
Regulatory Affairs Manager
Hiossen Inc.
85 Ben Fairless Dr.
Fairless Hills, Pennsylvania 19030

Re: K251491
Trade/Device Name: K5 Cart, K5 Mount, K5 Swing
Regulation Number: 21 CFR 872.6640
Regulation Name: Dental Operative Unit And Accessories
Regulatory Class: Class I, reserved
Product Code: EIA, KLC
Dated: June 20, 2025
Received: June 20, 2025

Dear Leszczak Mateusz:

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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K251491 - Leszczak Mateusz
Page 2

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 (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-reporting-combination-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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-

Page 3

K251491 - Leszczak Mateusz
Page 3

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

Page 4

Indications for Use

Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions.	K251491
Please provide the device trade name(s).
K5 Cart, K5 Mount, K5 Swing
Please provide your Indications for Use below.
K5 is intended to supply power to and serve as a base for dental devices and accessories. This product is intended for use by dentist and dental assistance to assist dental treatment of patients for adjusting the position of the patient seat, operating the instruments, and supplying water into the oral cavity through a water line in dental clinical environments.
Please select the types of uses (select one or both, as applicable).	☒ Prescription Use (Part 21 CFR 801 Subpart D)☐ Over-The-Counter Use (21 CFR 801 Subpart C)

K5 Cart
Page 9 of 29

Page 5

Osstem Implant Co., Ltd. Chair Business
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

- 1/5 -

510(k) Summary

K251491

Date: July 16, 2025

1. Company and Correspondent making the submission

Submitter's Name: Osstem Implant Co., Ltd. Chair Business
Address: 192, Haebong-ro, Danwon-gu, Ansan-si, Gyeonggi-do, 15428, Republic of Korea
Contact: Ms. Jimin Hyun
Phone: +82-70-4871-0191
Correspondent's Name: Hiossen Inc.
Address: 85 Ben Fairless Dr. Fairless Hills, PA 19030
Contact: Mr. Mateusz Leszczak
Phone: +1-201-266-0657

2. Proposed Device

Trade or (Proprietary) Name: K5 Cart, K5 Mount, K5 Swing
Classification Name: Dental operative unit and accessories
Regulation Number: 21 CFR 872.6640
Device Classification: Class I
Classification Product Code: EIA, KLC

3. Predicated Device

K5(K233805)

4. Description

The K5 Cart, K5 Mount and K5 Swing are designed for dental treatment and are intended for dental use only and are intended for use by trained medical personnel only.

These devices consist of a foot controller, headrest, backrest, seat, armrest, doctor table, unit, dental light, auxiliary table and doctor stool.

Page 6

Osstem Implant Co., Ltd. Chair Business
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

- 2/5 -

5. Indication for use

K5 is intended to supply power to and serve as a base for dental devices and accessories. This product is intended for use by dentist and dental assistance to assist dental treatment of patients for adjusting the position of the patient seat, operating the instruments, and suppling water into the oral cavity through a water line in dental clinical environments.

6. Comparison of the Indications for Use

Predicated Device: 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.

The intended use of the predicated device and the subject device are the same, but more detailed information has been added on how the subject device is used to assist in dental treatment, so there is no effect on substantial equivalence.

7. Summary of Technological Characteristics with predicated device and proposed device

The K5 Cart, K5 Mount, K5 Swing functions in a manner similar to and is intended for the same use to the predicate device. Primarily, K5 Cart, K5 Mount, K5 Swing are substantially equivalent to the K5 (K233805) marketed by OSSTEM IMPLANT Co., Ltd.Chair Business and 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 Cart, K5 Mount, K5 Swing demonstrate that the devices are deemed to be substantially equivalent as described in a following comparison table:

Description	Proposed Devices	Predicate Device	Remark
Indications for Use	The K5 is intended to supply power to and serve as a base for dental devices and accessories. This product is intended for use by dentist and dental assistance to assist dental treatment of patients for adjusting the position of the patient seat, operating the instruments, and suppling water into the oral cavity through a water line in dental clinical environments.	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.	Different
Product Name	K5 Cart, K5 Mount, K5 Swing	K5	Same
510(k) No.	Proposed	K233805	-
Manufacturer	Osstem Implant Co., Ltd. Chair business	Osstem Implant Co., Ltd. Chair business	Same
Product Code	EIA, KLC	EIA, KLC	Same
Model Type	Mount type, Cart type, Swing type	Mount type, Cart type	Different
Unit Type	Single type	Single type	Same
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	Same

Page 7

Osstem Implant Co., Ltd. Chair Business
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

- 3/5 -

| Doctor Table | - 3-way syringe- Control of water supply,scaler vibration power, table height, patient position,System Power, Film viewer, Patient Chair Positioning, Light On/Off,Handpiece function, Timer, Mode Selection, LED Display | - : 3-way syringe- Control of water supply,scaler vibration power, table height, patient position,System Power, Film viewer, Patient Chair Positioning, Light On/Off,Handpiece function, Timer, Mode Selection, LED Display | Same |
| Assist Table | - 3-way syringe, HVE and SE suction- Patient chair positioning , Dental Light on/off, Control of water | - 3-way syringe, HVE and SE suction- Patient chair positioning , Dental Light on/off, Control of water | Same |
| Main Components | Foot controller, Headrest, Backrest, Seat, Armrest, Doctor Table, Unit, Dental Light, Assistant Table, Doctor Stool, Monitor Arm, Hanaro Console, Joystick Control | Chair, Unit, Table, Seat, Stool, Monitor Arm, Hanaro Console | Same |
| Syringe | 3-way syringe | 3-way syringe | Same |
| 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. | Same |
| Air Pressure | 550(min), 600kPa(max) | 550(min), 750kPa(max) | Different |
| Water Pressure | 250(min), 600kPa(max) | 250(min), 600kPa(max) | Same |
| Water System | City water supply | City water supply | Same |
| Water Sanitation System | Distilled water container added | Distilled water container added | Same |
| Cleaning | Waterline cleaning according to ISO 16954Waterline: Routine(Daily), Biofilm treatment(2 week)Water Flushing (each patient) | Waterline cleaning according to ISO 16954Waterline: Routine(Daily), Biofilm treatment(2 week)Water Flushing (each patient) | Same |
| Warmer | Heating Method : Heating CoilWater Temperature : 25℃~37 ℃Warmer Volume : 360mlWarmer Power : 300WWarmer input voltage : AC48V | Heating Method : Heating CoilWater Temperature : 25℃~37 ℃Warmer Volume : 360mlWarmer Power : 300WWarmer input voltage : AC48V | Same |
| Suction | HVE (High volume evacuator)SE | HVE (High volume evacuator)SE | Same |
| Patient Load | Max. 150kg | Max. 150kg | Same |
| Chair Height | Max. 850±30mm, Min. 450±30mm | Max. 840±30mm, Min. 440±30mm | Different |
| Back Rest | 0°±5° to 70°±5° | 0°±5° to 70°±5° | Same |
| Head Rest | -90° to 75° | -90° to 70° | Different |
| Patient contacting components | Seat: Polyvinyl ChlorideWaterline: Polyurethane resinsAirline: Polyurethane resinsSuction: A160613-way syringe: A16061Warmer: Stainless Steel 304Water block: C3604 | Seat: Polyvinyl ChlorideWaterline: Polyurethane resinsAirline: Polyurethane resinsSuction: A160613-way syringe: A16061Warmer: Stainless Steel 304Water block: C3604 | Same |
| Principle of Operation | The chair is operated, the rising S/W is activated and the chair is electrically operated.The handpiece is operated, pressing the foot control pedal opens the air supply valve to rotate the handpiece turbine.The 3-way syringe is operated by air | The chair is operated, the rising S/W is activated and the chair is electrically operated.The handpiece is operated, pressing the foot control pedal opens the air supply valve to rotate the handpiece turbine.The 3-way syringe is operated by air | Same |

Page 8

Osstem Implant Co., Ltd. Chair Business
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

- 4/5 -

pressure or electronic circuit S/W	pressure or electronic circuit S/W
Lift Motor	Electromotor	Electromotor
Dental Light	Available	Available
Foot Control	StandardWireless	StandardWireless
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 K5 Cart, K5 Mount, K5 Swing and K233805

Page 9

Osstem Implant Co., Ltd. Chair Business
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

- 5/5 -

8. Non-clinical Test Data

Electrical Safety and Electromagnetic compatibility

K5 Cart, K5 Mount, K5 Swing have been verified according to IEC 60601-1, IEC 60601-1-2, IEC 80601-2-60, IEC 60601-1-6 and thus have electrical safety.

Since these standards are verified according to the same standards as the predicated device, their electrical safety is equivalent to that of the predicate device.

Performance test

K5 Cart, K5 Mount, K5 Swing have been verified according to ISO 7494-1, ISO 7494-2, and thus the performance of the product has been demonstrated.

These standards have been verified according to the same standards as predicate devices, so the performance items are equivalent to predicate devices.

Software and System Verification and Validation

The proposed device is identical to the original device in all major software functions, except for the user interface.

The updated software was verified in accordance with IEC 62304 and the FDA Guidance Content of Premarket Submissions for Device Software Functions, so the original device and the submitted device are substantially equivalent, although they have different software versions.

9. Clinical Test Data

Clinical test data is not needed to characterize its performance and establish substantial equivalence.

10. Conclusion

Based upon the above mentioned data and comparison table, the K5 Cart, K5 Mount, K5 Swing are 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.