Not Found
No
The summary describes a standard dental unit and chair with basic functionalities and does not mention any AI or ML components.
No
The device is described as a dental treatment unit and chair intended to supply power to and serve as a base for dental devices. While it is used in a clinical setting by trained professionals for dental treatment, its primary function is not to directly diagnose, treat, or prevent disease, but rather to facilitate procedures performed by other dental instruments.
No
The device is described as a "dental treatment unit" that supplies power to and serves as a base for dental devices and accessories, including a dental chair and a 3-way syringe for supplying air, water, or spray. Its function is to aid dental application, not to diagnose.
No
The device description explicitly states it is a "Dental Unit and Chair" and includes a "3way syringe," which are physical hardware components. While software verification and validation are mentioned, the core device is not software-only.
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, for use in a dental clinic environment by trained personnel. This describes a device used in a clinical setting for patient treatment, not a device used to examine specimens in vitro (outside the body).
- Device Description: The description focuses on the physical components and functions related to dental treatment (dental chair, 3-way syringe for air/water/spray in the mouth). It references standards for dental treatment units and instruments.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), reagents, or any other elements typically associated with in vitro diagnostics.
The device is clearly intended for direct use in dental procedures on patients, which falls under the category of medical devices used for treatment or diagnosis in vivo (within the body) or for supporting such procedures.
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 product includes a dental chair. The dental treatment unit is intended for use in the dental clinic environment and is used by trained dentists and/or dental assistants.
Product codes (comma separated list FDA assigned to the subject device)
EIA
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.
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.
K3 Mount and K3 Cart consist of the chair, unit, table, seat, stool, 3-way syringe, monitor arm, foot control and console.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
children and adults
Intended User / Care Setting
trained dentists and/or dental assistants.
dental clinic environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 evaluation for K3 components was conducted in accordance with the FDA Guidance Document and International Standard ISO 10993-1. Upholstery, waterlines, and airlines were tested for cytotoxicity (ISO 10993-5).
A representative sample of the 3-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. Sterilization testing was conducted according to ISO 17665-1:2006 and ISO 17665-2.
Cleaning/disinfection was conducted on the waterlines of the subject device. Validation was conducted using ISO 16954:2015, ISO 19458:2006, and ISO/TS 11080:2009. Microbiological simulation test and physical & chemical test were performed to ensure effective cleaning of the Dental chair waterline.
Comprehensive performance testing, including EMC testing in accordance with EN/IEC 60601-1-2 and electrical, mechanical, and environmental safety testing according to EN/EC 60601-1, was conducted. Usability testing was conducted in accordance with EN/EC 60601-1-6 and EN/IEC 62366.
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 clinical studies are submitted.
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.
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.
0
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
1
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
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use | Form Approved: OMB No. 0910-012
Expiration Date: January 31, 2017
See 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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
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:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
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
3
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
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.
4
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 electronically | |
| controlled dental operative unit with | ||
| accessories that are intended to | ||
| supply power to, and serve as a base | ||
| for dental devices and accessories. | 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. | ||
| Code | EIA | EIA |
| Power and | ||
| Utility supply | 110V/220V AC electrical supply, | |
| compressed air and water | AC 100-120/220-240V, 50/60Hz, compressed | |
| air and water | ||
| Protection Class | Class 1 equipment | Class 1 equipment |
| Applied parts | Type B | Type B |
| Components | Doctors element, assistants element, flex | |
| arm, utility center with optional | ||
| cuspidor, patient chair, treatment light, | Chair, Unit, Table, Seat, Stool, Chair, Unit, | |
| Table, Seat, Stool, Monitor Arm*, Hanaro | ||
| Console* |
Comparison Table
5
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 cart | |
| mounted dentist element Installed by | ||
| trained technicians. | Same as | |
| Syringe | 3-way syringe / | |
| Sprayvit | 3-way syringe | |
| Curing light | Mini LED | N/A |
| Control of Air | ||
| and water | Uses pneumatically controlled vales to | |
| Water control the flow of air and water. | ||
| On/off and intensity controlled by foot | ||
| pedal. | Same as | |
| Air Pressure | 550 kPa/750 kPa (min/max) | 500kPa(min)/750kPa(max) |
| Water | ||
| Pressure | 250 kPa/600 kPa(min/max) | 250kPa(min)/600 kPa(max) |
| Water System | User may select self-Contained water | |
| system or city water supply | City water supply | |
| Suction | ||
| devices | HVE (High volumeevacuator) | |
| Saliva Ejectors | HVE (High volume evacuator) | |
| Saliva Ejectors | ||
| Patient load | Max. 135kg | Same as |
| Chair Height | Max.755mm | |
| Min. 395mm | Max. 790±10mm | |
| Min. 450±10mm | ||
| Back Rest | 0° to 60° | 0° to 66° |
| Head Rest | -10° to 45° | -10° to 45° |
| LiftMotor | Motor SL (electricmotor) | Hydraulic electromotor |
| Electrical | ||
| Safety | Comply with IEC 60601-1 | Same as |
| EMC | Comply with IEC 60601-1-2 | Same as |
| Place of Use | Dental office, hospital | Same as |
| Intended | ||
| Users | Dentists, Dental Hygienists, Dental | |
| Equivalent 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.
6
1st floor, B-dong, 135 Gasan digital 2-ro,Geumcheon-gu, Seoul, Republic of Korea. 153-759
6. Indication for use
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.
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.
7
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 61000-3-2 |
| EN 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 & wastewater | |
| system | ISO 7494-2 | |
| 7 | Dentistry-Patient chair | ISO 6875 |
| 8 | Basic safety & essential performance | |
| of 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
8
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