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 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.

Device Description

TAURAUS C1 is a dental chair and units to be used to take for diagnosis and therapy of patients. It consists of the main unit and accessories.

The dental chair is used for patient to sit during the dental diagnosis, treatment and /or operation. The dental unit consists of patient chair, dentist table with instrument holders, assistant table, water unit, arm system, cuspidor (spittoon) and dental light. The dental unit system is used by trained dentists and /or dental assistants to supply air, water, vacuum and electrical power to dental devices and accessories to allow the dental practitioner an intuitive control center for all common and normal patient treatment procedures performed in the dental operatory.

AI/ML Overview

The provided text is a 510(k) summary for the TAURUS C1 Dental System. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving stand-alone clinical accuracy or comparative effectiveness with human readers through typical acceptance criteria studies.

Therefore, the document does not contain the information requested regarding acceptance criteria related to device performance in terms of diagnostic accuracy, sensitivity, specificity, or other performance metrics commonly associated with AI/algorithm-driven devices. It also does not include information on sample sizes for test sets, data provenance, expert ground truth adjudication, MRMC studies, or training set details.

The "performance data" section (Section VII) focuses on non-clinical testing to ensure safety and compliance with relevant standards, rather than clinical performance metrics.

Here's a breakdown of why the requested information is not present based on the provided text:

A table of acceptance criteria and the reported device performance: Not applicable in this context. The "acceptance criteria" here are compliance with international safety and performance standards (e.g., IEC, ISO). The "reported device performance" refers to the successful completion of these non-clinical tests.

Acceptance Criterion (Standard Compliance)	Reported Device Performance
IEC 60601-1 (Basic safety & essential performance)	Fulfilled
IEC 60601-1-2 (EMC)	Fulfilled
ISO 7494-1 (Dental units - General req.)	Pass
ISO 7494-2 (Dental units - Water & air supply)	Pass
ISO 6875 (Dental patient chair req.)	Pass
Biocompatibility	Materials already cleared for patient contact, similar to predicate device

Sample size used for the test set and the data provenance: Not applicable. There is no "test set" in the sense of clinical data or images for performance evaluation. The testing involved physical device compliance with standards.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no ground truth established by experts for performance evaluation. The "ground truth" relates to the technical specifications and safety requirements of the device.
Adjudication method for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a dental operative unit, not an AI-driven diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm-only device.
The type of ground truth used: For the purposes of this submission, the "ground truth" is compliance with the technical specifications and safety standards (e.g., a chair must articulate in a certain way, the electrical system must meet specific safety ratings).
The sample size for the training set: Not applicable. There is no "training set" as this is not an AI/machine learning device.
How the ground truth for the training set was established: Not applicable.

In summary, the provided document details a 510(k) submission for a physical dental operative unit. The "performance data" section refers to engineering and safety compliance testing against recognized international standards, not clinical performance or artificial intelligence algorithm evaluation.

Summary

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

January 22, 2016

Shinhung Company, Ltd. c/o Mr. Dave Kim Medical Device Regulatory Affairs Mtech Group 8310 Buffalo Speedway Houston, Texas 77025

Re: K151996

Trade/Device Name: Taurus C1 Regulation Number: 21 CFR 872.6640 Regulation Name: Operative Dental Unit and Accessories Regulatory Class: I Product Code: EIA Dated: December 9, 2015 Received: December 15, 2015

Dear Mr. 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, 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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Page 2 - Mr. Dave Kim

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 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 vours.

Tina Kiang -

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K151996

Device Name

TAURUS C1

Indications for Use (Describe)

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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Traditional 510(k) Summary

This 510(k) summary is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date 510k summary prepared: December 10, 2015

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)6366-2124
Contact person:	Sky Shin( sky@shinhung.co.kr) / Manager
Official Correspondent:(U.S. Designated agent)	Dave Kim (davekim@mtech-inc.net)
Address:	8310 Buffalo Speedway, Houston, TX 77025
Telephone:	+713-467-2607
Fax:	+713-583-8988

II. DEVICE

Trade/proprietary name	:	TAURUS C1
Common or Usual Name	:	Dental Chair and Units
Regulation Name	:	Dental Operative Unit and Accessories
Regulation Number	:	21 CFR 872.6640 (Product Code: EIA)
Regulatory Class	:	I Class
Prescription Use.

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III. PREDICATE DEVICE

Primary Manufacturer	:	A-DEC, INC
Device Name	:	A-DEC 200 DENTAL SYSTEM
510(k) Number	:	K102234 (Decision Date – Jan. 13, 2012)
Regulation Name	:	Dental Operative Unit and Accessories
Regulation Number	:	21 CFR 872.6640 (Product Code: EIA)
Regulatory Class	:	I Class

Prescription Use

This predicate has not been subject to a design-related recall.

No reference devices were used in this submission.

DEVICE DESCRIPTION IV.

TAURAUS C1 is a dental chair and units to be used to take for diagnosis and therapy of patients. It consists of the main unit and accessories.

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INDICATIONS FOR USE: V.

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 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.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE VI. DEVICE

	Model	A-dec 200 (K102234)	TAURUS C1 for 510K
	Indications for Use	The A-dec 200 DentalSystem and accessories areintended for use in generaldental applications byproviding the dentalpractitioner a user interfaceto control operation of thedental chair and attacheddental devices. The systemdelivers air, water, vacuumand electricity to allow thedental practitioner anintuitive control center forall common and normalpatient treatment proceduresperformed in the dentaloperatory	The TAURUS C1 DentalSystem and accessories areintended for use in generaldental applications byproviding the dentalpractitioner a user interfaceto control operation of thedental chair and attacheddental devices. The systemdelivers air, water, vacuumand electricity to allow thedental practitioner anintuitive control center forall common and normalpatient treatment proceduresperformed in the dentaloperatory.
	Construction	CHAIR / UNIT / DOCTORTABLE /ASSISTANTTABLE / OPERATINGLIGHT / FOOTCONTROLLER / STOOL	CHAIR / UNIT/ DOCTORTABLE /ASSISTANTTABLE / OPERATINGLIGHT / FOOTCONTROLLER / STOOL
	Power Supply /Frequency	AC100V/110V/120V,AC210/220/230V , 50/60Hz	AC100V/110V/115V,AC210/220/230V, 50/60Hz
	PowerShockProtection	Class 1	Class 1
	Electric Protection	B Type	B Type
		EN 60601-1-2	EN 60601-1-2
	EMC Standard	IEC 61000-3-2	IEC 61000-3-2
		IEC 61000-3-3	IEC 61000-3-3
	DentalunitsStandard	ISO 7494-1ISO 7494-2	ISO 7494-1ISO 7494-2
	Dental Patientchair Standard	ISO 6875	ISO 6875
	Safety Standard	EN 60601-1	EN 60601-1
	Chair Operatingsystem	Hydraulic system	Hydraulic system
Description(Comparativetestingconfirmedequivalenceto the notedpredicate)	UNIT/CHAIRform type	Over-arm Contour type	Over-arm Contour type
	Vacuum system	Central Vacuum system	Central Vacuum system orAir Vacuum system
	3-Way Syringe	Adjusting the Water / Air /Spray function is used in thesyringe button.	Adjusting the Water / Air /Spray function is used in thesyringe button.
	Cuspidor(Spittoon)	Spittoon bowl / Rinsing pipe/ Tumbler filler	Spittoon bowl / Rinsing pipe/ Tumbler filler
	Water System	City Water / Distilled Water	City Water / Distilled Water
		Comparative testingconfirmed equivalence tothe noted predicate
	Light headstructure	3-axis head adjustmentmethod	3-axis head adjustmentmethod
OperatingLight	ON/OFF control	Auto and manual ON/OFF	Auto and manual ON/OFF
	Headrest	Double-articulatingheadrest	Double-articulatingheadrest
	Safety switchfunction	Chair lift arm and auxiliaryarm, 2 safety switches	Chair lift arm and auxiliaryarm, 2 safety switches
		The safety switch stops thechair operation.	The safety switch stops thechair operation.
			chair	chair
	Programmablechair position	Programmableposition:Total 4 positions	Programmableposition:Total 5 positions
Deliverysystem	Handpiece holder	5 angle adjustable holders	6 integrated rotation typeholder
		Handl e	Adjustable handle	Fixed handle
		Touchpad	Membrane panel	Membrane Panel
		Handpiece waterand air cooling	Manually adjustablehandpiece water / air cooling	Manually adjustablehandpiece water / air cooling
		Flexarm tension	Control the tension to adjustthe shift of flexarm rotationflow.	Control the tention to adjustthe shift of TABLE ARMrotation.
Accessoriestools	Accessories holder	HVE, SE, 3-WAY syringeattached	HVE, SE, 3-WAYsyringeattached
		Holder structure	Rotation and individualholder	Fixed, one-piece holder
Supportcenter	Cuspidor	Self-contained 2 liter waterbottle system	Attach/detachable GLASS,disassemble for cleaning
		Sol i ds c ol lec tor	Equipped	Equipped
		Distilled waterreservoir	Equipped	Equipped
		Cup water system	Manual water systemPress the cupfill button for atimed operation. Press andhold the cupfill button formanual operation.	Automatic and manual watersystem.Place the cup at the specifiedlocation for a timedoperation.
Accessoriesattached tothe device:	handpiece / Low speed handpiece / Scaler / Curing light / Dental Chair / 3-waysyringe
OperationMethod	Control panel / Assistant control panel / Foot controller

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VII. PERFORMANCE DATA

The following performance data was provided in support of the substantial equivalence determination.

Biocompatibility testing:

TAURUS C1 dental operative unit and accessories use the materials already cleared for patient contact components such as patient chair seat, arm rest, 3 way syringe,

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vacuum syringe, and saliva ejector which are similar to the predicate device.

Non Clinical testing:

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. 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 ISo6875 test was performed for general, electrical, and mechanical requirements: Pass

VIII. CONCLUSIONS

There are no significant differences between the TAURUS C1 and the predicate device.

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification Shinhung Co, Ltd. concludes that TAURUS C1 is substantially equivalent in comparison with Adec-200, 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.