EMS PIEZON MASTER 600

K022328 · Electro Medical Systems SA · ELC · Aug 13, 2002 · Dental

Device Facts

• Record ID: K022328
• Device Name: EMS PIEZON MASTER 600
• Applicant: Electro Medical Systems SA
• Product Code: ELC · Dental
• Decision Date: Aug 13, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.4850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EMS Piezon® Master 600 is an ultrasonic scaler intended for use in the following dental and periodontal applications: Removing supra and subgingival calculus deposits and stains from teeth . Periodontal pocket lavage with simultaneous ultrasonic tip movement . Scaling and root planing . Releasing crowns, bridges, inlays, and posts as well as condensing gutta percha . Plugging for amalgam condensation . Amalgam burnishing . Preparing, cleaning and irrigating root canals . Cavity preparation . Cementing inlays and onlays . Retrograde preparation of root canals

Device Story

The EMS Piezon® Master 600 is an ultrasonic scaler used in dental clinics by dental professionals. It functions by delivering ultrasonic vibrations to specialized tips for cleaning, restorative, and endodontic procedures. The device consists of a main unit with a peristaltic pump for irrigation, handpieces, and a foot control. Modifications from the predicate include enhanced ultrasonic performance, improved ergonomics, irrigation flow control on the handpiece hose, and a foot-controlled boost function. It offers three operating modes with selectable power ranges and multiple irrigation sources. The device aids clinicians in performing precise dental procedures, potentially improving procedural efficiency and patient outcomes through versatile application capabilities.

Clinical Evidence

Bench testing only. Verification and validation activities included electrical safety testing, electromagnetic compatibility testing, and Design Control Checklists to ensure design requirements were met.

Technological Characteristics

Ultrasonic scaler; main unit with peristaltic pump, handpieces, and foot control. Features: ultrasonic boost function, three selectable power modes, multiple irrigation sources (bottles/external). Connectivity: foot control interface. Sterilization: not specified. Materials: not specified. Technology: ultrasonic vibration for dental/periodontal applications.

Indications for Use

Indicated for dental and periodontal procedures including calculus/stain removal, periodontal pocket lavage, scaling, root planing, restorative procedures (crown/bridge/inlay/post release, amalgam condensation/burnishing, inlay/onlay cementing), and endodontic procedures (root canal preparation/cleaning/irrigation, retrograde preparation). For use by dental professionals.

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

• Piezon Master 400 (K896749)
• EMS KERMIT® (K992504)

Submission Summary (Full Text)

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AUG 1 3 2002

Ko22328

# Special 510(k): Device Modification 510(k) Summary for Electro Medical Systems SA EMS PIEZON® MASTER 600

#### 1. SPONSOR

ELECTRO MEDICAL SYSTEMS SA Chemin de la Vuarpilliere 31 CH-1260 Nyon Switzerland

Contact Person: Suzanne Fassio Regulatory Manager

Date Prepared: July 17, 2002

#### 2. Device Name

Trade/Proprietary Name: EMS Piezon® Master 600 Common/Usual Name: Ultrasonic Scaler Classification Name: Ultrasonic Scaler

### 3. Predicate Devices

- . Piezon Master 400 (K896749)
- EMS KERMIT® (K992504) ●

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# INTENDED USE 4.

The EMS Piezon® Master 600 is an ultrasonic scaler intended for use in the following dental and periodontal applications:

- Removing supra and subgingival calculus deposits and stains from teeth .
- Periodontal pocket lavage with simultaneous ultrasonic tip movement .
- Scaling and root planing .
- Releasing crowns, bridges, inlays, and posts as well as condensing gutta ● percha
- Plugging for amalgam condensation .
- Amalgam burnishing ●
- Preparing, cleaning and irrigating root canals .
- Cavity preparation .
- . Cementing inlays and onlays
- Retrograde preparation of root canals ●

# ഗ് DEVICE DESCRIPTION

The proposed Piezon® Master 600 is a modification of the Piezon® Master 400. The modified Piezon® Master 600 consists of the main scaler unit (including a peristaltic pump for irrigant delivery), hoses and connectors for two handpieces, a foot control containing a four-position switch, and two bottles for holding irrigation liquids. The Piezon® Master 600 is supplied with one of a number of optional Instrument Systems (containing a Universal handpiece and scaling instruments), a flat key, and a torque tool (CombiTorque) for attaching instruments to the handpiece.

## 6. BASIS FOR SUBSTANTIAL EQUIVALENCE

The modifications made to the parent Piezon® Master 400 to produce the proposed EMS Piezon® Master 600 were implemented to enhance the procedural flexibility and improve the ease of use of the device. These modifications do not alter the general intended use or fundamental scientific technology of the device.

Both the proposed and parent devices are ultrasonic scalers intended for use in dental and periodontal cleaning, preparatory, and restorative procedures. The capability of the Piezon® Master 600 ultrasonic scaler was enhanced to include the cavity preparation, cementation of inlays and onlays, and retrograde preparation of root canals. These applications were cleared for use with the EMS KERMIT®.

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The overall design of the EMS Piezon® Master 600 is identical to the design of the unmodified Piezon® Master 400. The design modifications made to produce the EMS Piezon® Master 600 were implemented to improve the convenience and ease of use of the device and allow use of the Piezon® Master 600 with all instruments available for the EMS ultrasonic scaler product line. These design enhancements include the following:

- . Enhanced ultrasonic performance
- Improved handpiece appearance and ergonomics .
- . Irrigation liquid flow control moved to the handpiece hose
- Selection of dry and wet work functions moved to foot control .
- Addition of ultrasonic boost function to foot control ●
- Addition of three operating modes with different ultrasonic power ranges . selectable from main scaler unit
- Availability of three irrigation sources including two irrigation bottles and . external water supply

### 7. PERFORMANCE TESTING

The appropriate design verification and design validation activities were conducted to address the potential risks identified in the Hazard Analysis. These activities included electrical safety testing, electromagnetic compatibility testing, and the completion of Design Control Checklists to ensure that all design requirements were fulfilled. The results confirm that the modified EMS Piezon® Master 600 is safe and effective for the indicated dental and periodontal cleaning, preparatory, and restorative procedures.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 3 2002

Electro Medical Systems SA C/O Ms. Cynthia J. M. Nolte Medical Device Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760

Re: K022328 Trade/Device Name: EMS Piezon® Master 600 Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: July 17, 2002 Received: July 18, 2002

Dear Ms. Nolte:

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.

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.

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Page 2 - Ms. Nolte

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 proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Patricia Cucinotta/Jr

Timothy A. Ulatowski 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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510(k) Number (if known):

Device Name: EMS Piezon® Master 600

Indications for Use:

The EMS Piezon® Master 600 is an ultrasonic scaler intended for use in the following dental and periodontal applications:

- Removing supra and subgingival calculus deposits and stains from teeth .
- . Periodontal pocket lavage with simultaneous ultrasonic tip movement
- . Scaling and root planing
- . Releasing crowns, bridges, inlays, and posts as well as condensing gutta percha
- . Plugging for amalgam condensation
- . Amalgam burnishing
- Preparing, cleaning and irrigating root canals ●
- Cavity preparation .
- Cementing inlays and onlays ●
- . Retrograde preparation of root canals

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Allie Goehner for MSR

nesthesiology, General Hospital. arting Control Dental I

510(k) Number: K022328

Prescription Use
(Per 21 CFR 801.109)
✓

OR

Over-The-Counter Use

(Optional Format 1-2-96)

July 17, 2002