SIROSON L AND SIROSONIC L ULTRASONIC SCALERS

K033640 · Sirona Dental Systems GmbH · ELC · Dec 12, 2003 · Dental

Device Facts

• Record ID: K033640
• Device Name: SIROSON L AND SIROSONIC L ULTRASONIC SCALERS
• Applicant: Sirona Dental Systems GmbH
• Product Code: ELC · Dental
• Decision Date: Dec 12, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Sirona Sirosonic L and Siroson L are an ultrasonic scalers intended for use in the following dental and periodontal applications: . Calculus removal (supragingival and subgingival) . . Retrograde root treatment . . Endodontics . . Insertion of inlays . . Micropreparation-(cavity preparation) . . Periodontology

Device Story

Ultrasonic scalers for dental/periodontal procedures; consist of handpiece, instrument tips, and control unit integrated into Sirona C8+ Dental Operative Unit. Piezo oscillator in handpiece generates 25-32 kHz ultrasonic vibrations. Operator adjusts power via rotary knob on control unit; activates energy delivery via foot control. Includes integrated lamp and spray water controller for irrigation. Used by dental professionals in clinical settings. Output consists of mechanical ultrasonic energy for tissue/calculus removal and cavity preparation. Irrigation flow managed via handpiece control ring or C8+ unit knob. Benefits include precise calculus removal and preparation capabilities.

Clinical Evidence

Bench testing only. Verification and validation activities included electrical safety testing and electromagnetic compatibility testing to address identified hazards.

Technological Characteristics

Piezoelectric ultrasonic scaler; 25-32 kHz operating frequency. Integrated into C8+ Dental Operative Unit. Features include handpiece, interchangeable tips, foot control, and irrigation system. Electrical energy source. Software-controlled power delivery.

Indications for Use

Indicated for dental and periodontal applications including calculus removal (supragingival and subgingival), retrograde root treatment, endodontics, insertion of inlays, micropreparation (cavity preparation), and periodontology.

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

• EMS Piezon Master 600 (K022328)

Submission Summary (Full Text)

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K033640

DEC 1 2 2003

# 510(k): Device Modification 510(k) Summary

## for

### Siroson L and Sirosonic L Ultrasonic Scalers

#### SPONSOR 1.

Sirona Dental Systems GmbH Farbrikstrasse 31 64625 Bensheim Germany

Contact Person: Fritz Kolle Regulatory Manager

Date Prepared: November 18, 2003

#### 2. Device Name

| Proprietary Name: | Siroson and Sirosonic L Ultrasonic Scalers |
|----------------------|--------------------------------------------|
| Common/Usual Name: | Ultrasonic Scaler |
| Classification Name: | Ultrasonic Scaler |

#### 3. Predicate Devices

EMS Piezon Master 600 (K022328)

#### 4. INTENDED USE

The Sirona Sirosonic L and Siroson L are an ultrasonic scalers intended for use in the following dental and periodontal applications:

- . Calculus removal (supragingival and subgingival)
- . Retrograde root treatment
- . Endodontics
- . Insertion of inlays
- . Micropreparation-(cavity preparation)
- . Periodontology

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#### DEVICE DESCRIPTION ನ.

The proposed Sirona ultrasonic scalers consist of the ultrasonic handpiece, instrument tips, and control unit, which is part of the Sirona C8+ Dental Operative Unit. The Ultrasonic Scalers are electrically operated scalers driven by a piezo oscillator at 25 to 32 kHz. The piezo oscillator is located in the handpiece and the control/generator unit is located in the C8+ Dental Operative Unit. Both devices include a lamp located in the hose and a spray water controller. A number of optional tips are supplied with the Sirona ultrasonic scalers.

#### BASIS FOR SUBSTANTIAL EQUIVALENCE 6.

The overall design of the Sirona Ultrasonic Scalers is similar to the design of the Piezon® Master 600. Both these devices include a dental handpiece and ultrasonic generator. They all contain software, which controls delivery of the ultrasonic power, and include various tip configurations for the differing dental procedures.

On both the proposed and predicate Piezon 600 scaler units, the ultrasonic power can be adjusted via a rotary knob on the control unit and delivery of the ultrasonic energy is via a foot control.

The Sirona Scalers and the Piezon® Master 600 allow the operator to select among different operating modes. These modes have different ultrasonic power ranges to assist the operator in maintaining the ultrasonic power within an appropriate range for specific applications.

Both systems allow for irrigation using a bottled water source or an external water source. Irrigation is controlled from the handpiece using a control ring for the Sirona Scalers and a flow regulator for the Piezon® Master 600. Irrigation flow for the Sirona Scalers can also be controlled using a rotary knob on the C8+ dentist's element.

Based on the comparison of intended use and technical features, Sirona Dental Systems believes that the Siroson L and the Sirosonic L are substantially equivalent to the Piezon® Master 600. The proposed and predicate devices have the same general intended use and principles of operation. The overall design of the proposed and predicate devices is similar.

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#### 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 and electromagnetic compatibility testing. The results confirm that the Siroson L and the Sirosonic L are safe and effective for their intended uses.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure with outstretched wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 2 2003

Sirona Dental Systems GmbH C/O Ms. Mary McNamara-Cullinane, RAC Staff Consultant Medical Device Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760

Re: K033640

Trade/Device Name: Siroson L and Sirosonic L Ultrasonic Scalers Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: November 18, 2003 Received: November 20, 2003

Dear Ms. McNamara-Cullinane:

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 ndicetions 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, certo 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. Trounday, controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulterstion.

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 yan 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. Mary McNamara-Cullinane

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 proceed 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]. 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) you may obtain. 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,

CluLs

Chiu S. Lin, PhD 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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K033640 510(k) Number (if known):

Siroson L and the Sirosonic L Ultrasonic Scalers Device Name:

Indications for Use:

The Sirona Dental Systems Siroson L and the Sirosonic L are ultrasonic scalers intended for use in the following dental and periodontal applications:

- Calculus removal (subgingival and supragingival) .
- Retrograde root treatment .
- . Endodontics
- Insertion of inlays .
- Micropreparation (cavity preparation) .
- . Periodontology

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Swser Rurr

ision Sign-C ign-Off)
Anesthesiology, General Hospital, on Control, Dental

510(k) Number

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use ___________

(Optional Format 1-2-96)

November 18, 2003