The purpose of the device is to remove plaque from the surface of the tooth through using ultrasonic vibration generated by the electricity(24 V ~) and water supply received in a dental chair and other dental devices.

The product is provided in the form of parts that can be installed and used inside a dental chair and other dental devices. The control of the water supply is made from the dental chair and other dental devices.

AI/ML Overview

The provided text is a 510(k) summary for a dental ultrasonic scaler, the "Compact S." It focuses on demonstrating substantial equivalence to a predicate device, the "CLEANSE S+," rather than presenting a performance study with acceptance criteria in the manner typically used for new AI/ML-driven medical devices.

Therefore, many of the requested details, such as the sample size for the test set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set details, are not applicable or not present in this document. This document is a regulatory submission for a physical medical device, not a software-based diagnostic AI.

Here's an attempt to extract and describe what's available based on the provided text, and point out what is missing:

Device Name: Compact S, Compact S (LED)
Device Type: Ultrasonic Scaler (Dental)

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a table of specific quantitative acceptance criteria for clinical performance against which the device was tested to demonstrate accuracy. Instead, it relies on demonstrating functional and technological equivalence to a predicate device and compliance with relevant electrical and safety standards.

Acceptance Criteria Category	Reported Device Performance (Summary)
Electrical Safety	Met IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) requirements.
Electromagnetic Compatibility (EMC)	Met IEC 60601-1-2: 2007 (Third Edition) requirements.
Basic & Essential Performance	Met requirements (detailed criteria not specified, but implied to be similar to predicate).
Software Validation	Met requirements (per IEC 62304: 2006).
Sterilization & Cleaning Validation	Met requirements (per ISO 17665-1/2).
Biocompatibility	Met requirements (per ISO 10993-1: 2009).
Functional Equivalence	Demonstrated through comparison to predicate (CLEANSE S+), with differences not affecting safety or performance. Key functional parameters (e.g., frequency range, water supply pressure, handpiece output) were shown to be similar or within acceptable ranges.
Indications for Use	Identical to predicate device.

Study Information Pertaining to Device Performance:

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: Not applicable. This submission relies on bench testing and comparison to a predicate device, not a clinical test set with patient data for diagnostic accuracy.
Data Provenance: Not applicable. (No patient data was used).

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

Not applicable. No ground truth based on patient data with expert consensus was established as this was not a clinical performance study for an AI/ML device.

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

Not applicable. No test set involving human interpretation requiring adjudication was used.

5. 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 physical ultrasonic scaler, not an AI-assisted diagnostic tool for human readers.

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

Not applicable. This is a physical device, not an algorithm. Bench tests were performed on the device itself.

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

For functional and safety testing: Ground truth was based on engineering specifications, regulatory standards (like IEC 60601-1, IEC 60601-1-2, IEC 80601-2-60, ISO 17665-1/2, IEC 62304, ISO 10993-1), and the performance characteristics of the predicate device. For example, "Maximum output power with load" was tested against a specified value (24VA).

8. The sample size for the training set:

Not applicable. This is not an AI/ML device and does not involve a training set.

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

Not applicable.

Summary of Approach:

This 510(k) submission demonstrates substantial equivalence by showing that the "Compact S" device is fundamentally the same as its predicate, "CLEANSE S+," with minor structural modifications (removal of exterior case, keypad) that do not affect safety or performance. The primary method of proving this was through:

Bench Testing: Non-clinical performance testing for electrical safety, EMC, basic/essential performance, software validation, sterilization/cleaning validation, and biocompatibility.
Comparison to Predicate: Demonstrating that the indications for use, core functional characteristics (frequency range, water supply pressure, handpiece output), and main components are either identical or acceptably similar to the predicate device.
No Clinical Testing: The submission explicitly states, "No clinical testing was conducted to support this submission," as substantial equivalence was established through non-clinical data and comparison to the predicate.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name encircling a symbol. The symbol is a stylized representation of three human profiles facing right, stacked on top of each other. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

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

December 27, 2017

DMETEC Co., Ltd. % Yang Dong CEO Onbix Corporation #821 Samil Plaza, 14, Dogok-ro 1-gil Gangnam-gu, Seoul 06253 KR

Re: K170104

Trade/Device Name: Compact S Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: Class II Product Code: ELC Dated: November 22, 2017 Received: November 30, 2017

Dear Yang Dong:

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.

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

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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,

Mary S. Runner -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

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Indications for Use

510(k) Number (if known) K170104

Device Name COMPACT S, COMPACT S(LED)

Indications for Use (Describe)

removing supra and subgingival calculus and stains
periodontal pocket lavage with simultaneous ultrasonic tip movement
scaling and root planning
releasing crowns, bridges, inlays and posts as well as condensing gutta percha
plugging for amalgam condensation
amalgam burnishing
preparing, cleanig, and irrigating root canals
preparing approximal cavites
cementing inlays and onlays
retrograde preparation of root canals

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.

Submitter Information:	DMETEC Co., Ltd.
	402-601,602,603 bucheon techno-park,
	655 pyeongcheon-ro, wonmi-gu
	Bucheon-city gyeonggi-do, KOREA, REPUBLIC OF 420-734

Contact Person: Ho Dong, Yang
Onbix Corporation
#821 Samil Plaza, 14, Dogok-ro 1-gil, Gangnam-gu
Seoul, Korea (06253)
Tel: 82-2-566-3360 / Fax: 82-2-6280-3360
Email: onbix@naver.com

Date Summary Prepared: Dec 27, 2017

Device Information:

Trade Name(s): Classification Name: Panel: Product Code & Requlation: COMPACT S. COMPACT S(LED) SCALER, ULTRASONIC

dental ELC / 872.4850

Predicate Device Information:

K060171 / CLEANSE S+ ULTRASONIC SCALER / DMETEC Co., Ltd.

Device Description:

Indications for Use:

removing supra and subgingival calculus and stains
periodontal pocket lavage with simultaneous ultrasonic tip movement
scaling and root planning
releasing crowns, bridges, inlays and posts as well as condensing gutta percha
plugging for amalgam condensation
amalgam burnishing
preparing, cleanig, and irrigating root canals
preparing approximal cavites
cementing inlays and onlays
retrograde preparation of root canals

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Summary of the technological characteristics compared to the predicate device

The proposed Compact S is virtually identical to the previously approved CLEANSE S + (ULTRASONIC SCALER, K060171).

Compact S is a model of drive module with the exterior case, power control keypad, and control device removed from the body of the previously approved product (CLEANSE S +), and can be installed to the dental chair.

The difference between the input powers of the two devices is that the previously approved product uses an adapter, and the proposed product is in a different form, powered by the dental chair.

The output current is also lowered from 40 VA to 24 VA due to structural changes due to the removal of the control keypad. However, the output of the handpiece is similar for both devices.

The difference between the two devices does not affect their safety or performance.

The device was conducted in compliance with the following Standard

IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) : Medical electrical equipment Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2: 2007 (Third Edition) : Medical Electrical Equipment PART 1-2: General Requirements for Basic Safety and Essential Performance Collateral Standard: Electromagnetic Compatibility
IEC 80601-2-60: 2012 (First Edition) : Medical electrical equipment: Part 2: Particular requirements for basic safety and essential performance of dental equipment

	DMETEC(COMPACT S)	DMETEC(Cleanse S+)
510(k)reference	Proposed	K060171
Indication foruse	- removing supra and subgingivalcalculus and stains- periodontal pocket lavage withsimultaneous ultrasonic tip movement- scaling and root planning- releasing crowns, bridges, inlays andposts as well as condensing guttapercha- plugging for amalgam condensation- amalgam burnishing- preparing, cleanig, and irrigating rootcanals- preparing approximal cavites- cementing inlays and onlays- retrograde preparation of root canals	- removing supra and subgingivalcalculus and stains- periodontal pocket lavage withsimultaneous ultrasonic tipmovement- scaling and root planning- releasing crowns, bridges,inlays and posts as well ascondensing gutta percha- plugging for amalgamcondensation- amalgam burnishing- preparing, cleanig, and irrigatingroot canals- preparing approximal cavites- cementing inlays and onlays- retrograde preparation of rootcanals
Supplyvoltage	AC/DC 24 V, 50/60 Hz	Transformer input : 100-240 VAC , 50/60 HzTransformer output : DC 24V
Water supplypressure	1 to 5 bar (15 to 72 psi)	1 to 5 bar (15 to 72 psi)
Maximumoutput powerwith load	24VA	40VA

Comparison table is as follows

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Frequency range available	24-32 kHz			24-32 kHz
mode	Continuous			Continuous
Connection to second scaler unit	Not allowed			Not allowed
Main component	• Unit Body : 1ea• Hand-piece : 1ea(Normal type or LED type)• Tip(Basic) : 3ea• Tip(option) : 2ea			• Unit Body : 1ea• Hand-piece : 1ea(Normal type)• Tips(Basic) : 3ea• Tip(option) : 2ea
	* Compact S is a model of drive module with the exterior case, power control keypad, and control device removed from the body of the previously approved product (CLEANSE S +), and can be installed to the dental chair.*The COMPACT S and Cleanse S + use the same handpiece made from the same material.
	COMPACT S&COMPACT S LED			Cleanse S+
	1	Vibrator	Titanium+SU S	1	Vibrator	Titanium+SU S
	2	Outsider cap	PPSU/25mm80-170	2	Outsider cap	PPSU/25mm80-170
		Outsider cap(LED Type)	$17.6Φ*23.7m$m
	3	H.P BODY	PPSU/68mm140-170	3	H.P BODY	PPSU/68mm140-170
		H.P BODY(LED Type)	PPSU/70mm$18.5Φ$ - $17.5Φ$
	4	HP Socket(Upper)	PPSU/12.5mm 150	4	HP Socket(Upper)	PPSU/12.5mm 150
	5	HP socket(down)	PPSU/15mm11.50	5	HP socket(down)	PPSU/15mm11.50
	6	Handpiece C	PPSU/19mm8	6	Handpiece C	PPSU/19mm8
	7	O-ring 3 $Φ$1.8T	Rubber/006	7	O-ring 3 $Φ$1.8T	Rubber/006
	8	Vibrator O-ring down	10 $Ø$ *1mm	8	Vibrator O-ring down	10 $Ø$ *1mm
	9	Handpiece socket O-ring Upper	Rubber/S11	9	Handpiece socket O-ring Upper	Rubber/S11
	10	Water pin O-ring1 $Φ$ 1T	Rubber/P2	10	Water pin O-ring1 $Φ$ 1T	Rubber/P2
	11	Terminal pin female	4*21.8mm	11	Terminal pin female	4*21.8mm
	12	Water pin	inside1 $Ø$4*21mm	12	Water pin	inside1 $Ø$ 4*21mm
	13	LED Module(LED Type)	$Ø$ 15.2*18.5mm	-
	*The difference between the two types of handpieces is the presence or absence of LEDs illuminating the mouth.

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Tip material(contact withpatient)	Stainless steel(SUS420J2) ※ The COMPACT S and Cleanse S + use the same shaped tip for the samematerial.	Stainless steel(SUS420J2)
-------------------------------------------	--------------------------------------------------------------------------------------------------------------------------	---------------------------

Summary of Non-Clinical performance testing as basis for substantial equivalence

Non-clinical performance testing demonstrates that all design inputs for the Compact S is satisfied by the design outputs. Testing of the device, when integrated with a dental chair and handpiece was performed. Results of the integration testing showed that the device met electrical safety (IEC 60601-1) and electromagnetic compatibility (IEC 60601-1-2) requirements. Additional integration testing included basic and essential performance as well as validation of the software in its actual use. Results from the functional and performance testing showed that the device met the predetermined acceptance criteria. The similarities in intended use, operational characteristics, and functional technological characteristics between the proposed Compact S and the parent Clenase S+ lead to a conclusion of substantial equivalence between the proposed and predicate device.

The results of this testing confirm that the Compact S is as safe and effective as the predicate device for the intended use.

Summary of clinical test as basis for substantial equivalence.

No clinical testing was conducted to support this submission.

Summary of non-clinical performance testing

all performance bench tests, sterilization and cleaning validations, biocompatibility, electrical and EMC and software.

The device was conducted in compliance with the following Standard

IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) : Medical electrical equipment Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2: 2007 (Third Edition) : Medical Electrical Equipment PART 1-2: General Requirements for Basic Safety and Essential Performance Collateral Standard: Electromagnetic Compatibility
IEC 80601-2-60: 2012 (First Edition) : Medical electrical equipment: Part 2: Particular requirements for basic safety and essential performance of dental equipment
· ISO 17665-1/2 Sterilization of health care products
· IEC 62304: 2006 : Medical device software Software life-cycle processes
ISO 10993-1: 2009 : Biological evaluation of medical devices biocompatibility

Conclusion drawn from non-clinical and clinical tests

The similarities in intended use, operational characteristics, and functional technological characteristics between the proposed COMPACT S and the Cleanse S+ lead to a conclusion of substantial equivalence between the proposed and predicate device

Regulation Number and Section

§ 872.4850 Ultrasonic scaler.

(a)
Identification. An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.(b)
Classification. Class II.