(268 days)
No
The description focuses on the mechanical and electrical functions of a dental chair and does not mention any AI/ML capabilities.
No
The device is described as a dental chair designed to position patients and supply power to dental devices, not to treat any medical condition directly.
No
The device description clearly states its purpose is to "supply power to and serve as a base for dental devices and accessories" and to "provide seating for patients during dental procedures" to "position the patient during treatment." It does not mention any function for diagnosing conditions.
No
The device description explicitly states it includes a physical dental chair with adjustable components, tools, and attachments, indicating it is a hardware device.
Based on the provided information, the Luvis Chair is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the Luvis Chair is for positioning patients during dental procedures and supplying power to dental devices. It does not mention any use for examining specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description focuses on the physical components of a dental chair and its function in supporting dental procedures. There is no mention of any components or functions related to analyzing biological samples.
- Lack of IVD-related information: The document does not contain any information typically associated with IVD devices, such as:
- Mentions of image processing, AI, DNN, or ML in the context of analyzing biological data.
- Input imaging modality related to biological samples.
- Anatomical site in the context of sample collection or analysis.
- Descriptions of training or test sets for algorithms that analyze biological data.
- Performance metrics like sensitivity, specificity, PPV, or NPV, which are relevant to diagnostic accuracy.
In summary, the Luvis Chair is a piece of dental equipment used for patient positioning and power supply, not for the in vitro examination of biological specimens.
N/A
Intended Use / Indications for Use
Luvis Chair is intended to supply power to and serve as a base for dental devices and accessories. This Device includes a dental chair and is intended for use in the dental clinic environment and is designed for use by trained dental professionals, dentists and/or dental assistants.
Product codes (comma separated list FDA assigned to the subject device)
KLC, EIA
Device Description
The Luvis Chair (LC700C) includes a chair used by dentists to provide seating for patients during dental procedures. It is designed to position the patient during treatment. The chair consists of a seat, backrest, and armrests that can be adjusted to accommodate the patient's position. Additionally, it may feature a headrest to offer additional support.
Dental unit chairs come equipped with various tools and attachments, including dental lights, suction devices, and air- water syringes. The chair's controls are usually located within reach of the dentist, allowing for quick adjustments during the procedure. The Luvis Chair is intended to supply power to and serve as a base for dental devices and accessories.
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
Not Found
Intended User / Care Setting
trained dental professionals, dentists and/or dental assistants. / dental clinic environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Luvis Chair (LC700C) is verified and validated according to the FDA design control requirements, 21 CFR 820. The subject device had been subjected to the applicable safety and performance testing before release to ensure the device meets all its specifications. The quality assurance measures applied to the design and development of the subject device include, but not limited to risk analysis, verification and validation, product specifications and design reviews.
Thermal, electrical, mechanical safety & Electromagnetic Compatibility
The Luvis Chair (LC700C) complies with the electrical safety and electromagnetic compatibility requirements established by the standards below:
- ANSI AAMI ES60601-1 General requirements for basic safety and essential performance
- IEC 60601-1-2 General requirements for basic safety and essential performance -Collateral Standard: Electromagnetic disturbances
- IEC 80601-2-60 Particular requirements for the basic safety and essential performance of dental equipment
Software Validations
The Luvis Chair (LC700C) utilizes original software. The Luvis Chair (LC700C) contains Basic documentation level, and MODERATE level of concern software. Software was designed and developed according to a software development process and was verified and validated.
Biocompatibility
The biocompatibility evaluation for the Luvis Chair (LC700C) was conducted in accordance with FDA guidance:
- "Guidance for the Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, issued on September 8, 2023"
- ISO 7405 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
The biocompatibility testing included the following tests: - In vitro cytotoxicity test
- Oral mucosa Irritation test
- Skin sensitization test
- In vitro cytotoxicity test Agar diffusion method
- In vitro cytotoxicity test Filter diffusion method
Performance Test
The performance test for Luvis Chair (LC700C) was conducted in accordance with the standards below:
- IEC 80601-2-60 Particular requirements for the basic safety and essential performance of dental equipment
- ISO 7494-1 Dentistry - Stationary dental units and dental patient chairs - Part 1: General requirements
- ISO 7494-2 Dentistry - Dental units - Part 2: Air, water, suction and waste water systems
Cleaning and Sterilization Validation
Reprocessing validation testing has conducted in accordance with FDA guidance:
"Guidance for Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued on March 17, 2015"
The cleaning and sterilization was conducted in accordance with the standards below:
- ISO 17665-1 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
- ISO TS 17665-2 Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1
Dental unit waterline biofilm treatment testing has conducted in accordance with the standards below: - ISO 16954 Dentistry - Test methods for dental unit waterline biofilm treatment
- ISO 19458 Water quality - Sampling for microbiological analysis
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.
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
§ 872.6250 Dental chair and accessories.
(a)
Identification. A dental chair and accessories is a device, usually AC-powered, in which a patient sits. The device is intended to properly position a patient to perform dental procedures. A dental operative unit may be attached.(b)
Classification. Class I. The dental chair without the operative unit device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 6, 2024
DENTIS CO., LTD. Kaon Kim Junior Manager 99, Seongseoseo-Ro, Dalseo-Gu Daegu. 42718 SOUTH KOREA
Re: K233921
Trade/Device Name: Luvis Chair (LC700C) Regulation Number: 21 CFR 872.6250 Regulation Name: Dental Chair and Accessories Regulatory Class: Class I, reserved Product Code: KLC, EIA Dated: August 12, 2024 Received: August 12, 2024
Dear Kaon 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 (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.
1
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 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-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 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-device-advicecomprehensive-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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-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-regulatory
2
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
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Luvis Chair (LC700C)
Indications for Use (Describe)
Luvis Chair is intended to supply power to and serve as a base for dental devices and accessories. This Device includes a dental chair and is intended for use in the dental clinic environment and is designed for use by trained dental professionals, dentists and/or dental assistants.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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 PRAStaff(@fda.hhs.gov
"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."
4
Image /page/4/Picture/0 description: The image shows the word "DENTIS" in bold, black letters. To the left of the word is an orange, curved graphic. The graphic is a stylized representation of a dental tool or a tooth.
510(k) Summary - K233921
[As required by 21 CFR 807.92]
1. Date Prepared [21 CFR 807.92(a)(1)]
September 5th, 2024.
2. Submitter's Information [21 CFR 807.92(a)(1)]
- Name of Applicant: DENTIS CO., LTD. 99, Seongseoseo-Ro, Dalseo-Gu, Daegu, - Address: 42718, Korea, South - Name of Manufacturer: DENTIS MEDICAL DIVISION - Address: 6, Yuram-ro, Dong-gu, Daegu, 41065, Korea, South - Contact Person: Kaon Kim / Junior Manager - Telephone No.: +82-53-583-2804 - Fax No.: +82-53-583-2806 - Email Address: kaonkim@dentis.co.kr - Registration No.: 3010373494
3. Trade Name, Regulation Name, Classification [21 CFR 807.92(a)(2)]
| Device Name | Luvis Chair (LC700C) |
|---|---|
| Regulation Number | 21 CFR 872.6640 |
| Common/Usual Name | Dental Unit Chair |
| Regulatory Class | Class I |
| Product Code | EIA |
| Classification Name | unit, operative dental |
| Panel | Dental |
5
Image /page/5/Picture/0 description: The image shows the word "DENTIS" in bold, black letters. To the left of the word is an orange, abstract symbol that resembles a flame or a stylized letter 'O'. The overall design is simple and clean, suggesting a professional or corporate identity.
4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)]
The identified predicate and reference devices within this submission are shown as follow;
Predicate device
- 510(k) Number: K183347
- Applicant: Osstem Implant Co., Ltd.
- Device Name: K3
- Regulation Number: 21 CFR 872.6640
- Regulation Name: Dental Operative Unit and Accessories
- Regulatory Class: Class I
- Product Code: EIA
- Classification Name: unit, operative dental
Reference device
- K211556 - 510(k) Number: - Applicant: MeqaGen Implant Co., Ltd. - Device Name: N2 - Regulation Number: 21 CFR 872.6640 - Regulation Name: Dental Operative Unit and Accessories - Requlatory Class: Class I - Product Code: EIA
- Classification Name: unit, operative dental
The Luvis Chair (LC700C) is substantially equivalent to the predicate devices with respect to intended use, principles of operation, and technological characteristics. The subject device has the same Indications for Use and similar technological characterizes as compared to the predicate and reference devices. Therefore, the Luvis Chair (LC700C) is considered substantially equivalent to the predicate and reference devices.
5. Description of the Device [21 CFR 807.92(a)(4)]
The Luvis Chair (LC700C) includes a chair used by dentists to provide seating for patients during dental procedures. It is designed to position the patient during treatment. The chair consists of a seat, backrest, and armrests that can be adjusted to accommodate the patient's position. Additionally, it may feature a headrest to offer additional support.
Dental unit chairs come equipped with various tools and attachments, including dental lights, suction devices, and air- water syringes. The chair's controls are usually located within reach of the dentist, allowing for quick adjustments during the procedure. The Luvis Chair is intended to supply power to and serve as a base for dental devices and accessories.
6
Image /page/6/Picture/0 description: The image contains the logo for DENTIS. The logo consists of an orange swirl shape on the left, followed by the word "DENTIS" in black, bold, sans-serif font. The swirl is a stylized representation of a tooth or dental element.
[Note] The handpieces and scalers are not included within the scope of this submission. Furthermore, HVE and Saliva Ejector Tips are not included within the scope of the submission.
1) The Luvis Chair (LC700C) is classified as shown below:
LC700C consists of the following:
| Model
Number | Chair Part | Unit Part | Dr. Table | Assist
Table | Foot
Controller | Note |
|-----------------|------------|----------------------------|--------------------|-----------------|--------------------|------|
| LC700C | • | •
Dental Light:
C700 | •
Mount
Type | • | • | |
- Description of main components and specifications
The components of the Luvis Chair (LC700C) consist of following items:
| Model
| Number | Parts | Description | Note |
|---|---|---|---|
| LC700C | Chair Part | Chair Part | |
| Unit Part | Dental Light | C700 | |
| Instrument 1 | 3-Way Syringe | ||
| Dr. Table | Instrument 2,3 | ||
| (Air High) | 1. Air High Handpiece (Not | ||
| included in the submission) | |||
| Instrument 4 | |||
| (Air Low / Elec. | |||
| Low) | 1. Air Low Handpiece (Not | ||
| included in the submission) |
- Elec. Low Handpiece (Not
included in the submission) |
| | | Instrument 5
(Scaler) | 1. Scaler (Not included in the
submission) |
| | Assist Table | Instrument 1 | Dry Air Syringe |
| | | Instrument 2 | 3-Way Syringe |
| | | Instrument 3 | HVE |
| | | Instrument 4 | Saliva Ejector |
| | Foot
Controller | Foot Controller | |
6. Indications for Use [21 CFR 807.92(a)(5)]
Luvis Chair 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.
7
Image /page/7/Picture/0 description: The image shows the word "DENTIS" in bold, black letters. To the left of the word is an orange, curved shape that resembles a flame or a stylized letter 'D'. The logo appears to be for a dental-related company or product, given the association with teeth.
7. Comparison of Technological Characteristics with the Predicate Device
Summary of technological characteristics of the device compared to the predicate device. [21 CFR 807.92(a)(6)]
| Applicant | DENTIS CO., LTD. | Osstem Implant Co., Ltd. | MegaGen Implant Co.,
Ltd. | SE Note |
|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Device Name | Luvis Chair (LC700C) | K3 | N2 | - |
| | Subject Device | Predicate Device | Reference Device | - |
| 510(k)
Number | K233921 | K183347 | K211556 | - |
| Common/Usu
al Name | Dental Unit Chair | Unit, Operative Dental | Unit, Operative Dental | - |
| Regulation
Number | 21 CFR 872.6640 | 21 CFR 872.6640 | 21 CFR 872.6640 | - |
| Product Code | EIA | EIA | EIA | - |
| Class | Class I | Class I | Class I | - |
| Model
Number | LC700C | K3 | N2 | - |
| Indications
for Use | Luvis Chair is intended to
supply power to and serve
as a base for dental
devices and accessories.
This device includes a
dental chair and is
intended for use in the
dental clinic environment
and is designed for use by
trained dental
professionals, dentists
and/or dental assistants. | K3 is intended to supply
power to and serve as a
base for dental devices
and accessories. This
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. | N2 is intended to supply
power to and serve as a
base for dental devices
and accessories. This
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. | Similar |
| Dentist
Element Type
(Dr. Table
Type) | Mount Type | Mount Type, Cart Type | Mount Type, Cart Type | Similar |
| Unit Type | Single Type | Single Type | A Type, B Type | Same |
| Supply Mains | 100-120/220-240 Va.c.,
50/60 Hz | 100-120/220-240 Va.c.,
50/60 Hz | 100-120/220-240 Va.c.,
50/60 Hz | Same |
| Utility Supply | Compressed air, and
Water | Compressed air, and
Water | Compressed air, and
Water | Same |
| Main
Components | Chair Part, Unit Part,
Table(Dr. Table, Assist
Table), Chair Seat, Stool,
Monitor Arm, Compact
Console | Chair, Unit, Table, Seat,
Stool, Monitor Arm*,
Hanaro Console* (Note: K3
Cart* model applied ONLY) | Chair, Unit, Table, Seat,
Stool, Monitor Arm,
Operation Table | Similar |
| Dentist
Element
(Dr. Table) | 1) Accessories: 3-Way
Syringe
2) Control of Water Supply,
Scaler Vibration Power,
Table Height, Patient Chair
Positioning, Light On/Off,
Handpiece Function,
Timer, Mode Selection,
LED Display | 1) Accessories: 3-Way
Syringe
2) 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 | 1) Accessories: 3-Way
Syringe
2) Control of Water Supply,
Scaler Vibration Power,
Table Height, Patient Chair
Positioning, Handpiece
Function, Timer, LED
Display | Similar |
| Assist
Element
(Assist Table) | 1) Accessories: Suction
(Saliva Ejector, HVE), Dry
Air Syringe, 3-Way Syringe
2) Light On/Off,
Cup/Spittoon Water
Dispenser, Changing the
Settings, Position
Memories, 1 Person
Helper System | 1) Accessories: Saliva
Ejector (Small, Large), 3-
Way Syringe
2) Light On/Off,
Cup/Spittoon Water
Dispenser, Changing the
Settings, Position
Memories | 1) Accessories: Saliva
Ejector, HVE (Small,
Large), 3-Way Syringe
2) Second Assi Power
Switch, Waterline Power
Switch, Control of Water,
Light On/Off, Position
Memories, Spittoon Wash | Similar |
| Syringe | Dry Air Syringe, 3-Way
Syringe | 3-Way Syringe | 3-Way Syringe | Similar |
| Control of
Water and Air | Uses pneumatically
controlled valves to water
control the flow of air and
water.
On/Off and intensity
controlled by foot pedal | Uses pneumatically
controlled valves to water
control the flow of air and
water.
On/Off and intensity
controlled by foot pedal | Uses pneumatically
controlled valves to water
control the flow of air and
water.
On/Off and intensity
controlled by foot pedal | Same |
| Water System | City Water Supply | City Water Supply | City Water Supply | Same |
| Cleaning | Cleaning method provided
for Chair Upholstery, Tray
Table, Assist Table, Dr. Table,
Spittoon, Suction Filter,
Suction(Saliva Ejector,
HVE), Dry Air Syringe, 3-
Way Syringe, and
Waterline | - | Waterline cleaning
according to ISO 16954
- Waterline: Routine (Daily)
- Shock Treatment
(2weeks)
Water Flushing (each
patient) | - |
| Warmer | Heating Method: Heating
Coil
Storage Container
Temperature: Max. 40°C
Water Temperature: Avg.
33 ~ 35°C
Temperature Sensor: Bi-
metallic Thermostats | - | Heating Method: Heating
Coil
Storage Container
Temperature: Max. 40°C
Water Temperature: Avg.
33 ~ 35°C
Temperature Sensor: Bi-
metallic Thermostats | - |
| Water
Sanitation
System | Distilled water container | Distilled water container | Distilled water container | Same |
| Suction | 1) HVE (High Volume
Evacuator)
- Saliva Ejector
- 1 Person Helper System | 1) HVE (High Volume
Evacuator) - Saliva Ejector | 1) HVE (High Volume
Evacuator) - Saliva Ejector
- Second Assi | Same |
| Air Pressure | 500kPa(Min) /
750kPa(Max) | 500kPa(Min) /
750kPa(Max) | 500kPa(Min) /
750kPa(Max) | Same |
| Water
Pressure | 215kPa(Min) /
275kPa(Max)
(2.5 ± 0.3 kgf/cm2) | 250kPa(Min) /
600kPa(Max) | 245 kPa(Max) | Similar |
| Patient Load | Max. 150 kg | Max. 135 kg | Max. 150 kg | Similar |
| Chair Height | Max. 770±50mm,
Min. 480±50mm | Max. 795±10mm,
Min. 365±10mm | Max. 700±10mm,
Min. 400±10mm | Similar |
| Back Rest | 0°±5° to 65°±5° | 0°±5° to 67°±5° | 0°±3° to 68°±3° | Similar |
| Head Rest | Double-articulating
headrest
First joint: -
$-150°+150°(±5°)$+174°(±5°)$ | -10 °to 45° | -50° to 14°±2° | Similar |
Second joint: -
$162°
| Lift Motor | Hydraulic Electromotor | Hydraulic Electromotor | Hydraulic Electromotor | Same |
| Dental Light | Available | Available | Available | Same |
| Foot Control | Available | Available | Available | Same |
| Electrical
Safety | Complied with IEC 60601-
1 | Complied with IEC 60601-
1 | Complied with IEC 60601-
1 | Same |
| Electromagne
tic
Compatibility | Complied with IEC 60601-
1-2 | Complied with IEC 60601-
1-2 | Complied with IEC 60601-
1-2 | Same |
| Patient
Contacting
Components | Seat: Polyvinyl Chloride,
Polyester
Waterline: Polyurethane,
Polyamide 66+ GF25%,
Stainless Steel (Chromium
plated), C3604 (Chromium
plated)
Airline: Polyurethane,
Polyamide 66+ GF25%,
C3604 (Chromium plated),
Aluminum Alloy
HVE: Aluminum Alloy
3-Way Syringe: C3604
(Chromium plated)
Dry Air Syringe: C3604
(Chromium plated)
Saliva Ejector: Aluminum
Alloy
Warmer: Stainless Steel
(Chromium Plated) | - | Seat: Polyvinyl Chloride,
Polyester
Waterline: Polyurethane
resin, Polyamide 66+
GF25%, Stainless Steel,
C3604, Silicon
Airline: Polyurethane,
Polyamide 66+ GF25%,
Aluminum Alloy
HVE: Aluminum Alloy
3-Way Syringe: C3604
(Chromium Plated),
Aluminum Alloy
Saliva Ejector: Aluminum
Alloy
Warmer: Stainless Steel
304 (Chromium Plated)
Water Block: C3604
(Chromium Plated) | Similar |
| Principle of
Operation | The chair is operated, the
rising S/W is activated and
the chair is hydraulically
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 pressure or
electronic circuit S/W | The chair is operated, the
rising S/W is activated and
the chair is hydraulically
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 pressure or
electronic circuit S/W | The chair is operated, the
rising S/W is activated and
the chair is hydraulically
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 pressure or
electronic circuit S/W | Similar |
8
Image /page/8/Picture/0 description: The image contains the word "DENTIS" in bold, black letters. To the left of the word is an orange, spiral-like graphic. The graphic appears to be a stylized representation of a tooth or a dental instrument. The overall design is clean and modern.
9
Image /page/9/Picture/0 description: The image shows the word "DENTIS" in bold, black letters. To the left of the word is an orange, curved shape that resembles a flame or a stylized letter "D". The logo appears to be for a dental-related company or product, given the association with the word "dentis".
b) Substantial Equivalence Discussion
The Luvis Chair (LC700C) is substantially equivalent to the predicate and reference devices identified above with respect to intended use, principles of operation, and technological characteristics. The subject device has the same Indications for Use and similar technological characterizes as compared to the predicate and reference devices. Therefore, the Luvis Chair (LC700C) is considered substantially equivalent to the predicate devices.
10
Image /page/10/Picture/0 description: The image contains the logo for DENTIS. The logo consists of an orange abstract shape on the left, resembling a stylized flame or a curved, layered design. To the right of the shape is the word "DENTIS" in bold, black capital letters.
8. Non-Clinical Test Summary
The Luvis Chair (LC700C) is verified and validated according to the FDA design control requirements, 21 CFR 820. The subject device had been subjected to the applicable safety and performance testing before release to ensure the device meets all its specifications. The quality assurance measures applied to the design and development of the subject device include, but not limited to risk analysis, verification and validation, product specifications and design reviews.
1) Thermal, electrical, mechanical safety & Electromagnetic Compatibility
The Luvis Chair (LC700C) complies with the electrical safety and electromagnetic compatibility requirements established by the standards below:
-
ANSI AAMI ES60601-1 General requirements for basic safety and essential performance - IEC 60601-1-2 General requirements for basic safety and essential performance -Collateral Standard: Electromagnetic disturbances
-
IEC 80601-2-60 Particular requirements for the basic safety and essential performance of dental equipment
2) Software Validations
The Luvis Chair (LC700C) utilizes original software. The Luvis Chair (LC700C) contains Basic documentation level, and MODERATE level of concern software. Software was designed and developed according to a software development process and was verified and validated.
Software information is provided in accordance with FDA guidance: "Guidance for the Content of Premarket Submissions for Software Functions, issued on June 14, 2023."
3) Biocompatibility
The biocompatibility evaluation for the Luvis Chair (LC700C) was conducted in accordance with FDA guidance:
-
"Guidance for the Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, issued on September 8, 2023"
-
ISO 7405 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
The biocompatibility testing included the following tests:
- In vitro cytotoxicity test
- Oral mucosa Irritation test
- Skin sensitization test
- In vitro cytotoxicity test Agar diffusion method
- In vitro cytotoxicity test Filter diffusion method
11
Image /page/11/Picture/0 description: The image contains the word "DENTIS" in bold, black letters. To the left of the word is an orange, curved graphic. The graphic is a stylized representation of a flame or a curved shape.
4) Performance Test
The performance test for Luvis Chair (LC700C) was conducted in accordance with the standards below:
-
IEC 80601-2-60 Particular requirements for the basic safety and essential performance of dental equipment
-
ISO 7494-1 Dentistry - Stationary dental units and dental patient chairs - Part 1: General requirements
-
ISO 7494-2 Dentistry - Dental units - Part 2: Air, water, suction and waste water systems
5) Cleaning and Sterilization Validation
Reprocessing validation testing has conducted in accordance with FDA guidance:
"Guidance for Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued on March 17, 2015"
The cleaning and sterilization was conducted in accordance with the standards below:
-
ISO 17665-1 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
-
ISO TS 17665-2 Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1
Dental unit waterline biofilm treatment testing has conducted in accordance with the standards below:
-
ISO 16954 Dentistry - Test methods for dental unit waterline biofilm treatment
-
ISO 19458 Water quality - Sampling for microbiological analysis
9. Conclusions [21 CFR 807.92(b)(3)]
In conclusion, the conducted tests, as well as all verification and validation activities, demonstrate that the design specifications and technological characteristics of the Luvis Chair (LC700C) meet applicable requirements and standards. The testing and validation activities conducted demonstrate that any differences between the subject device and the predicate devices do not raise new questions of safety and effectiveness compared to the predicate and reference devices. Therefore, the Luvis Chair (LC700C) is substantially equivalent to the predicate and reference devices.