(489 days)
No
The description focuses on the mechanical and control aspects of a dental chair and associated equipment, with no mention of AI or ML capabilities.
No
The device is described as a system that provides a user interface to control dental chair operations and deliver air, water, vacuum, and electricity for normal patient treatment procedures. It facilitates dental procedures but does not inherently provide therapy itself.
No
The device is described as a dental chair with an operative unit that controls other attached dental devices, and delivers air, water, vacuum, and electricity for patient treatment procedures. There is no indication that it is used to diagnose a medical condition.
No
The device description clearly outlines a physical dental chair with attached hardware components (operative unit, tables, water unit, arm system, cuspidor, dental light, foot control, syringe, saliva ejector). While there is a user interface mentioned, the core of the device is hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is for "general dental applications by providing the dental practitioner a user interface to control operation of the dental chair and attached dental devices." It facilitates patient treatment procedures performed in the dental operatory.
- Device Description: The description details a dental chair, operative unit, and various components used for patient positioning and delivering air, water, vacuum, and electricity during dental procedures.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of biological specimens.
The G7 Dental System is a piece of dental equipment used to support and facilitate dental procedures performed directly on the patient, not for in vitro testing of samples.
N/A
Intended Use / Indications for Use
The G7 Dental System and accessories are intended for use in general dental applications by providing the dental practitioner a user interface to control operation of the dental chair and attached dental devices. The system delivers air, water, vacuum and electricity to allow the dental practitioner an intuitive control center for all common and normal patient treatment procedures performed in the dental operatory.
Product codes (comma separated list FDA assigned to the subject device)
EIA
Device Description
The G7 dental chair with operative unit is a dental chair with an operative unit attached for patient to sit during the dental diagnosis, treatment and /or operation. The dental chair has adjustable headrest, backrest, seat height and armrests. The proposed device also consists of dentist table with instrument holders, assistant table, water unit, arm system, cuspidor (spittoon), dental light and foot control. The instrument holder includes a 3-way syringe and salvia ejector supplied by DCI which are cleared by FDA (K151987).
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
dental practitioner / dental operatory
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)
Non Clinical testing:
ISO 10993-1:209/(R) 2013 Biological evaluation of medical devices-Part1: Evaluation and testing within a risk management process.
IEC 60601-1 Test for Medical Electrical Equipment was performed for General Requirements for basic safety and essential performance. The requirements of specified standards were fulfilled.
IEC 60601-1-2 Test for Medical Electrical Equipment was performed for General Requirements for basic safety and essential performance (collateral standards: electromagnetic compatibility. The requirements of specified standards were fulfilled.
IEC 80601-2-60 Test for Particular requirements for the basic safety and essential performance of dental equipment. The requirements of specified standards were fulfilled.
ISO 7494-1 Test was performed for general requirements and test methods: Pass
ISO 7494-2 Test was performed for general requirements for water and air supply: Pass
Software Verification and Validation Testing:
Firmware for G7 includes PCB Foot Blu Slave MPU and Master MPU board to receive and transmit wireless foot controller signals. Software verification and validation testing were conducted and documented 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, since a failure or latent flaw in the software would not directly result in serious injury or death to the patient or operator.
All test results were satisfactory.
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
§ 872.6640 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/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 3, 2023
Shinhung Company Ltd % Dave Kim Medical Device Regulatory Affairs Mtech Group 7505 Fannin St. Suite 610 Houston, Texas 77054
Re: K213749
Trade/Device Name: G7, Dental Operative Unit and Accessories Regulation Number: 21 CFR 872.6640 Regulation Name: Dental Operative Unit And Accessories Regulatory Class: Class I, reserved Product Code: EIA Dated: March 6, 2023 Received: March 6, 2023
Dear Dave 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Michael E. Adjodha -S
Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K213749
Device Name G7 Dental System
Indications for Use (Describe)
The G7 Dental System and accessories are intended for use in general dental applications by providing the dental practitioner a user interface to control operation of the dental chair and attached dental devices. The system delivers air, water, vacuum and electricity to allow the dental practitioner an intuitive control center for all common and normal patient treatment procedures performed in the dental operatory.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ----------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------- |
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3
510(k) Summary K213749
510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
| Date 510k summary prepared: | 3/17/2022 |
|---|---|
| I. | |
| Submitter | |
| Submitter's Name : | Shinhung Co., Ltd. |
| Submitter's HQ Address: | Shinhung Bldg, 450, Cheongpa-ro, Jung-gu, |
| Seoul, 100-858, Korea | |
| Factory Address: | 42-25, 27beon-gil, Dongsan-ro, Danwon-gu, Ansan-si |
| Gyeonggi-Do, 425-852 Korea | |
| Submitter's Telephone: | +82 (2) 6366-2175 |
| Contact person: | Mr. Sam Su Kyong / |
| RA Manager | |
| Official Correspondent: | Dave Kim (davekim@mtech-inc.net) |
| (U.S. Designated agent) | Mtech Group |
| Address: | 7505 Fannin St. Ste 610, Houston, TX 77054 |
| Telephone: | +713-467-2607 |
II. Subject Device
| Trade/proprietary name | : G7 |
|---|---|
| Regulation Name | : Dental Operative Unit and Accessories |
| Regulation Number | : 21 CFR 872.6640 |
| Product Code | : EIA |
| Regulatory Class | : Class I |
4
Prescription Use.
III. Predicate Device
| 510(k) Number | K151996 (Jan. 22, 2016) |
|---|---|
| Primary Manufacturer | SHINHUNG. CO,.LTD |
| Device Name | TAURUS C1 |
| Regulation Name | Dental Operative Unit and Accessories |
| Regulation Number | 21 CFR 872.6640 |
| Product Code | EIA |
| Regulatory Class | Class I |
| Prescription Use |
This predicate has not been subject to a design-related recall.
Reference Device IV.
| 510(k) Number | K032756 (Dec. 04, 2003) |
|---|---|
| Primary Manufacturer | A-DEC, Inc |
| Device Name | A-DEC 532/533 |
| Regulation Name | Dental Operative Unit and Accessories |
| Regulation Number | 21 CFR 872.6640 |
| Product Code | EIA |
| Regulatory Class | Class I |
Prescription Use
V. Device Description
The G7 dental chair with operative unit is a dental chair with an operative unit attached for patient
5
to sit during the dental diagnosis, treatment and /or operation. The dental chair has adjustable headrest, backrest, seat height and armrests. The proposed device also consists of dentist table with instrument holders, assistant table, water unit, arm system, cuspidor (spittoon), dental light and foot control. The instrument holder includes a 3-way syringe and salvia ejector supplied by DCI which are cleared by FDA (K151987).
Indications for Use VI.
The G7 dental chair with operative unit is intended for use in general dental applications by providing the dental practitioner a user interface to control operation of the dental chair and attached dental devices. The system delivers air, water, vacuum and electricity to allow the dental practitioner an intuitive control center for all common and normal patient treatment procedures performed in the dental operatory.
| Model | TAURUS C1 (K151996) | G7 (K213749) | |
|---|---|---|---|
| Indications for | |||
| Use | The TAURUS C1 Dental | ||
| System and accessories are | |||
| intended for use in general | |||
| dental applications by | |||
| providing the dental | |||
| practitioner a user interface to | |||
| control operation of the dental | |||
| chair and attached dental | |||
| devices. The system delivers | |||
| air, water, vacuum and | |||
| electricity to allow the dental | |||
| practitioner an intuitive | |||
| control center for all common | |||
| and normal patient treatment | |||
| procedures performed in the | |||
| dental operatory. | The G7 dental chair with | ||
| operative unit is intended for | |||
| use in general dental | |||
| applications by providing the | |||
| dental practitioner a user | |||
| interface to control operation of | |||
| the dental chair and attached | |||
| dental devices. The system | |||
| delivers air, water, vacuum and | |||
| electricity to allow the dental | |||
| practitioner an intuitive control | |||
| center for all common and | |||
| normal patient treatment | |||
| procedures performed in the | |||
| dental operatory. | |||
| Construction | CHAIR / UNIT / DOCTOR | ||
| TABLE /ASSISTANT | |||
| TABLE / OPERATING | |||
| LIGHT / FOOT CONTROL / | |||
| STOOL | CHAIR /UNIT/ DOCTOR | ||
| TABLE /ASSISTANT | |||
| TABLE / OPERATING | |||
| LIGHT / FOOT CONTROL / | |||
| STOOL | |||
| Power Supply | AC110V/115V, 50/60Hz | AC110V/115V,50/60Hz | |
| Description | Power Shock | ||
| Protection | Class 1 | Class 1 | |
| Electric | |||
| Protection | B Type | B Type | |
| EMC Standard | EN 60601-1-2 | ||
| IEC 61000-3-2 | |||
| IEC 61000-3-3 | EN 60601-1-2 | ||
| IEC 61000-3-2 | |||
| IEC 61000-3-3 | |||
| Dental units | |||
| Standard | ISO 7494-1 | ||
| ISO 7494-2 | ISO 7494-1 | ||
| ISO 7494-2 | |||
| Dental unit& | |||
| chair particular | |||
| standard | - | IEC 80601-2-60 | |
| Safety Standard | IEC 60601-1 | IEC 60601-1 | |
| Chair Operating | |||
| system | Hydraulic system | Hydraulic system | |
| UNIT/CHAIR | |||
| form type | Over-arm Contour type | Over-arm Contour type | |
| Inlet Air | |||
| Pressure (Mpa) | 0.6 ~ 0.78MPa | 0.6 ~ 0.78MPa | |
| Inlet Water | |||
| Pressure (Mpa) | 0.2 ~ 0.59MPa | 0.2 ~ 0.59MPa | |
| Allowable | |||
| Patient Load | 150 Kgf | 150Kgf | |
| Vacuum system | Central Vacuum system or | ||
| Air Vacuum system | DCI vacuum system with HVE | ||
| and saliva ejectors (K151987) | |||
| Flushing system | N/A | Included | |
| Water treatment | |||
| with ICX tablet | N/A | Included | |
| 3-Way Syringe | Adjusting the Water / Air / | ||
| Spray function in the syringe | Adjusting the Water / Air / | ||
| Spray function in the syringe | |||
| with DCI tip (K151987) | |||
| Vacuum syringe | |||
| tip | Disposable tip | Not provided | |
| Vacuum syringe | POLY AMID, Durr | Aluminum, DCI | |
| Saliva-ejector | POLY AMID, Durr | Aluminum, DCI | |
| Low-speed / | |||
| High-speed | |||
| handpiece | Not provided | Not provided | |
| Scaler | Piezon kit, EMS | Piezon kit, EMS | |
| Cuspidor | Spittoon bowl / Rinsing pipe / | ||
| Tumbler filler | Spittoon bowl / Rinsing pipe / | ||
| Tumbler filler | |||
| Water System | City Water / Distilled Water | City Water / Distilled Water | |
| Operating | |||
| Light | Type | Halogen (Shin Hung) | EDI LED |
| Light head | |||
| structure | 3-axis head adjustment | ||
| method | 3-axis head adjustment | ||
| method | |||
| ON/OFF Control | Auto and manual ON/OFF | Auto and manual ON/OFF | |
| Brightness | |||
| control | 2 stage control | Continuous control | |
| Light pattern | 130mmX70mm @ 700mm | 130mmX70mm @ 700mm | |
| Loading | |||
| Capacity | 150kgf | 150kgf | |
| Dental | |||
| Chair | Movement | ||
| Range (Chair) | 530 ~825mm(± 20 mm) | 400~760mm(± 20 mm) | |
| Movement | |||
| Range (Backrest) | $0° ~ 63° (± 3°)$ | $0° ~ 70° (± 3°)$ | |
| Headrest | Double-articulating headrest | Double-articulating headrest | |
| Table arm | Manual system | Air brake system | |
| Safety switch | |||
| function | BACKREST and auxiliary | ||
| arm, 2 safety switches | Rink cover and swing cover | ||
| safety switch, emergency stop | |||
| button located on the back of | |||
| the chair seat, 3 safety | |||
| switches. | |||
| The safety switch stops the | |||
| chair operation. | The safety switch stops the | ||
| chair operation. | |||
| Programmable | |||
| chair position | Programmable chair position: | ||
| Total 5 positions | Programmable chair position: | ||
| Total 5 positions | |||
| Delivery | |||
| system | Handpiece | ||
| holder | 6 integrated rotation type | ||
| holder | 6 integrated rotation type | ||
| holder | |||
| Handle | Fixed handle | Fixed handle | |
| Touchpad | Membrane panel | Membrane Panel | |
| Handpiece water | Manually adjustable | Manually adjustable handpiece | |
| water / air cooling. | |||
| Flexarm tension | Control the tension to adjust | ||
| the shift of TABLE ARM | |||
| rotation. | Control the tension to adjust | ||
| the shift of TABLE ARM | |||
| rotation. | |||
| Accessories | Instrument | ||
| holders | HVE, SE, 3-WAYsyringe | ||
| attached | HVE, SE, 3-WAYsyringe | ||
| attached | |||
| Foot control | Standard, all-in-one | Standard, all-in-one, | |
| Cuspidor | Attach/detachable GLASS | ||
| disassemble for cleaning. | Magnetic cuspidor disassemble | ||
| for cleaning | |||
| Solids collector | Equipped | Equipped | |
| Support | |||
| center | Distilled water | ||
| reservoir | Equipped | Equipped | |
| Cup water | |||
| system | Automatic and manual water | ||
| supply system. | Automatic and manual water | ||
| supply system. | |||
| Watering time can be set by | |||
| the user. | Watering time can be set by | ||
| the user. | |||
| Operation | |||
| Method | Control panel / Assistant control panel / Foot controller |
VII. Comparison of Technological Characteristics with the Predicate Device
6
7
8
VIII. Comparison of Technological Characteristics with the Reference Device
| Model | A-DEC 532/533 (K032756) | G7 (K213749) | |
|---|---|---|---|
| Indications for | |||
| Use | The A-dec 532/533 Delivery | ||
| System Dental Unit and | |||
| accessories are intended for | |||
| use in general dental | |||
| applications by providing the | |||
| dental practitioner a user | |||
| interface to control operation | |||
| of the dental chair and | |||
| attached dental devices. The | |||
| system delivers air, water, | |||
| vacuum and electricity to | |||
| allow the dental practitioner | |||
| an intuitive control center for | |||
| all common and normal | |||
| patient treatment procedures | |||
| performed in the dental | |||
| operatory. | The G7 dental chair with | ||
| operative unit is intended for | |||
| use in general dental | |||
| applications by providing the | |||
| dental practitioner a user | |||
| interface to control operation of | |||
| the dental chair and attached | |||
| dental devices. The system | |||
| delivers air, water, vacuum and | |||
| electricity to allow the dental | |||
| practitioner an intuitive control | |||
| center for all common and | |||
| normal patient treatment | |||
| procedures performed in the | |||
| dental operatory. |
9
| | Construction | CHAIR / UNIT / DOCTOR
TABLE / ASSISTANT
TABLE / OPERATING
LIGHT / FOOT CONTROL /
STOOL | CHAIR /UNIT/ DOCTOR
TABLE / ASSISTANT
TABLE / OPERATING
LIGHT / FOOT CONTROL /
STOOL |
|--|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Vacuum syringe | Aluminum, DCI | Aluminum, DCI |
| | Saliva-ejector | Aluminum, DCI | Aluminum, DCI |
| | Flushing system | After each patient treatment,
discharge water from the
tubes of all handpieces for 20
to 30 seconds by using the
flushing system. The flush
switch is located at the bottom
left of the doctor's table. Pull
the flush switch and hold it
until the waste is completely
drained from the tubing.
When only air comes out,
release the flush switch. | After each patient treatment,
discharge water from the tubes
of all handpieces for 20 to 30
seconds by using the flushing
system. The flush switch is
located at the bottom left of the
doctor's table. Pull the flush
switch and hold it until the
waste is completely drained
from the tubing. When only
air comes out, release the flush
switch. |
| | Water treatment
with ICX tablet | A-dec ICX tablets are
specially formulated to
maintain dental unit
waterlines and prevent
accumulation of odor and foul
taste bacteria. Maintains
dental unit waterline effluent