(22 days)
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No
The document describes a standard ultrasonic scaler with a piezo oscillator and control unit. There is no mention of AI, ML, image processing, or data-driven algorithms.
Yes
The device is described as an ultrasonic scaler for dental and periodontal applications, including calculus removal and endodontics, which are therapeutic procedures.
No.
The device is an ultrasonic scaler used for various dental and periodontal treatments, not for diagnosing conditions.
No
The device description explicitly states that the device consists of hardware components including an ultrasonic handpiece, instrument tips, and a control unit, which are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "dental and periodontal applications" such as calculus removal, root treatment, endodontics, etc. These are all procedures performed directly on the patient's body or teeth.
- Device Description: The description details an ultrasonic scaler that operates mechanically to remove material from teeth. It does not involve the analysis of biological samples (blood, urine, tissue, etc.) outside of the body, which is the defining characteristic of an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for 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
Product codes (comma separated list FDA assigned to the subject device)
ELC
Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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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
1
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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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