The Cleanse S+ is an ultrasonic scaler consisting of a main chassis containing an external electric power supply, controls for water flow and ultrasonic intensity, displays, and ultrasonic generator. The device is connected directly to a water supply for irrigation during use. A footswitch used for on/off control is connected to the main chassis by a footswitch cord. A handpiece is connected to the main chassis by a handpiece cord. Instruments (stainless steel tips) designed for specific dental procedure are attached to the distal end of the handpiece.

AI/ML Overview

This submission pertains to the Cleanse S+ Ultrasonic Scaler.

1. A table of acceptance criteria and the reported device performance

The provided text does not contain explicit "acceptance criteria" for performance metrics in the traditional sense, nor does it report specific quantitative performance outcomes that would be measured against such criteria. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through comparisons of design, intended use, and non-clinical testing for safety standards.

The closest to a "performance" comparison is the table detailing "OUTPUT CHARACTERISTICS" between the Cleanse S+ and the predicate EMS miniPiezon.

Characteristic	Acceptance Criteria (Predicate EMS miniPiezon)	Reported Device Performance (Cleanse S+)
Maximum output power with load	8W	8W
Frequency range available	25-32 kHz	24-32 kHz

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not applicable. No clinical or performance testing involving a "test set" of patient data was conducted or described.
Data Provenance: Not applicable. The submission states, "No clinical testing was conducted." The non-clinical tests relate to electrical safety and electromagnetic compatibility standards (IEC 60601-1, EN 55011, EN 60601-1-2).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No clinical testing was performed, and therefore no "ground truth" was established by experts for a test set.

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

Not applicable. No clinical testing was performed requiring adjudication.

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 an ultrasonic scaler, not an AI-assisted diagnostic tool.

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

Not applicable. This device is an ultrasonic scaler, not an algorithm.

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

Not applicable. No clinical testing was performed. The "ground truth" for demonstrating safety and effectiveness was based on adherence to recognized electrical and electromagnetic compatibility standards and comparison to a legally marketed predicate device.

8. The sample size for the training set

Not applicable. This device is an ultrasonic scaler. No training set for an algorithm was used.

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

Not applicable. No training set for an algorithm was used.

Summary

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SECTION 5 MAR 2 9 2006

510(K) SUMMARY

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(K) number is:_ KOGOI 71.

Submitter's Identification: 1.
DMETEC CO.,LTD. #402-803 Techno-Park, 193 Yakdae-Dong, Wonmi-Ku, Bucheon, Korea Tel: +82-32-234-0011 Date Summary Prepared: January 20, 2006:

Name of the Device: 2.

Cleanse S+ Ultrasonic Scaler Proprietary Name: Classification Name: Scaler, Ultrasonic, product code ELC Classification: Class II, 21 CFR 872.4850

4. Predicate Device Information:

America Green Dent Cleanse S	K033044
EMS Mini Master	K953026
EMS Piezon Master 600	K022328
EMS miniPiezon	K953026

ડ. Device Description:

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Intended Use: 6.

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, cleaning, and irrigating root canals
preparing approximal cavities
Cementing inlays and onlays
Retrograde preparation of root canals

Comparison to Predicate Devices 7.

Cleanse S Ultrasonic Scaler - identical in component materials, including the handpiece, the scaler tips, and the sterilization box. Differs from the predicate in that the Cleanse S+ is a different unit design with different control functions (analog vs.digital), indicator lamps, and footswitch lock

EMS MiniMaster, (K050710), and EM.5 Piezon Master 600 (K022328): Same indications for use.

EMS miniPiezon legally marketed by under K953026: The Cleanse St Ultrasonic cleaner is similar in design, operation, and performance:

	DMETEC(Cleanse S+)	EMS(miniPiezon)
UNIT
Supply voltage	24V DC	24V AC
Supply frequency	-	50/60 Hz
Power consumption(max)	22W max	25W
Water supply pressure	1 to 5 bar(15 to 72 psi)	1 to 5 bar(15 to 72 psi)
OUTPUT CHARACTERISTICS
Maximum output power with load	8W	8W
Frequency range available	24-32 kHz	25-32 kHz
TRANSFORMER
Input	110-240 VAC, 50-60Hz	100/220 VAC/50-60Hz

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HANDPIECE AND TIPS	Reusable -- AutoclavableF ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------Comments of A + 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1	Reusable-Autoclavable ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Output	24V DC/ 1.7A	24V AC/ 1.25A

Discussion of Non-Clinical Tests Performed for Determination of Substantial 8. Equivalence are as follows:

Testing was conducted in accordance with: IEC 60601-1:88+A1:91+A2:95 used in conjunction with EN 60601-1:90+A1/A12:93+A2/A13:96, and EN 55011:98+A1:99 and EN 60601-1-2:2001

Discussion of Clinical Tests Performed: 9.

No clinical testing was conducted.

Conclusions: 10.

The Cleanse S-- ultrasonic scaler is substantially similar to the predicates in intended use, operation, safety and function, and is effective for its' intended use.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is surrounded by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" in a circular arrangement. The logo is black and white.

Public Health Service

MAR 2 9 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DMETEC Company Limited C/O Ms. Carolann Kotula Official Correspondent MDI Consultants, Incorporated 55 Northern Boulevard, Suite 200 Great Neck, New York 11021

Re: K060171

Trade/Device Name: Cleanse S+ Ultrasonic Scaler Regulation Number: 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: January 20, 2006 Received: January 24, 2006

Dear Ms. Kotula:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 - Ms. Kotula

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to procced to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincercly vours.

Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 4

Indications for Use

510(k) Number (if known): 长060171

Device Name: Cleanse S+ Ultrasonic Scaler

Indications For Use: Intended for use during dental procedures to:

-Remove supra and subgingival calculus and stains

Remove ouple and Subge 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, cleaning, and irrigating root canals
Preparing approximal cavities
Cementing inlays and onlays
Retrograde preparation of root canals

Prescription Use __ × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use __ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE:-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page of

Susan Pusone

infony, General Hostilla

Page Number K860171

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.