CLEANSE S+ ULTRASONIC SCALER

K060171 · Dmetec.Co., Ltd. · ELC · Mar 29, 2006 · Dental

Device Facts

• Record ID: K060171
• Device Name: CLEANSE S+ ULTRASONIC SCALER
• Applicant: Dmetec.Co., Ltd.
• Product Code: ELC · Dental
• Decision Date: Mar 29, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4850
• Device Class: Class 2
• Attributes: Therapeutic

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

Device Story

Cleanse S+ is an ultrasonic scaler for dental procedures. System includes main chassis with power supply, water flow/intensity controls, and ultrasonic generator; handpiece with stainless steel tips; footswitch for on/off control. Device connects to external water supply for irrigation. Operator (dentist/hygienist) selects intensity/flow settings; ultrasonic energy drives tip vibration to perform scaling, root planing, endodontic irrigation, or restorative tasks. Output is mechanical vibration of tip. Benefits include efficient removal of calculus/stains and precise dental preparation. Used in clinical dental settings.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing in accordance with IEC 60601-1 and EN 60601-1-2 standards.

Technological Characteristics

Ultrasonic scaler; 24V DC power; 24-32 kHz frequency range; 8W max output power. Components: main chassis, handpiece, stainless steel tips, footswitch. Water supply pressure 1-5 bar. Sterilization: autoclavable handpiece and tips. Standards: IEC 60601-1:88+A1:91+A2:95, EN 60601-1:90+A1/A12:93+A2/A13:96, EN 55011:98+A1:99, EN 60601-1-2:2001.

Indications for Use

Indicated for dental procedures including calculus/stain removal, periodontal lavage, scaling, root planing, endodontic preparation/irrigation, and restorative procedures (crown/bridge release, amalgam condensation, inlay/onlay cementing). No specific patient population age or gender restrictions provided.

Regulatory Classification

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.

Predicate Devices

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

Submission Summary (Full Text)

{0}------------------------------------------------

## 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: [phone] 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:

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.

{1}------------------------------------------------

#### 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 |

{2}------------------------------------------------

| HANDPIECE AND TIPS | Reusable -- Autoclavable<br>F ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>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 <br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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.

{3}------------------------------------------------

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.

{4}------------------------------------------------

### 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 [phone]. 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 [phone] or [phone] 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

{5}------------------------------------------------

## 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