(35 days)
The Sirona Dental Systems PerioScan Ultrasonic Scaler is an ultrasonic scaler intended for use in the following dental and periodontal applications:
- Removal of supragingival and subgingival calculus .
- Periodontal therapy .
- Preparing proximal cavities (micropreparation) .
- Seating tooth-colored inlays and onlays with highly thixotropic dual . curing cements
- Root canal irrigation .
- Retrograde root canal treatment ●
The Sirona PerioScan Ultrasonic Scaler consists of a table-top unit with two detachable irrigant bottles with lids, a footswitch, an ultrasonic handpiece, hoses and connectors, a variety of optional tips for different dental procedures, and a tool for attaching the tips to the handpiece.
The PerioScan table-top houses the operator input and controls for the supply of irrigant, cooling liquid and light for the handpiece. The device is connected to 115V mains power supply and it may be connected to an external water-supply. The irrigant for the handpiece is drawn from either of the two internal liquid containers or an external water supply. The handpiece is connected to the table-top unit via a hose and can be deposited in the claw. A footswitch with two single switches controls the handpiece. The PerioScan Handpiece is an electrically operated scaler driven by a piezo oscillator. The handpiece includes an illumination LED located in the hose and a spray water controller.
This document is a 510(k) summary for the Sirona Dental Systems PerioScan Ultrasonic Scaler. As such, it does not contain the detailed study results, acceptance criteria, or performance data typically found in a full clinical or engineering report.
The purpose of a 510(k) submission is to demonstrate substantial equivalence to a predicate device, not necessarily to prove efficacy or safety through new clinical studies. Therefore, much of the requested information regarding detailed acceptance criteria and specific study designs is not present in this summary.
However, based on the provided text, I can infer the following:
1. Table of Acceptance Criteria and Reported Device Performance
Strict acceptance criteria and quantified device performance metrics are not explicitly stated in this 510(k) summary. The submission focuses on demonstrating substantial equivalence to a predicate device rather than meeting pre-defined numerical performance targets.
Instead, the "performance" demonstrated is that the Sirona PerioScan is "substantially equivalent" to the EMS Piezon Master 600 (K022328) in terms of:
- Intended Use: Both devices are ultrasonic scalers for similar dental and periodontal applications.
- Technical Features: Both include dental handpieces and ultrasonic generators, control software for ultrasonic power, various tip configurations, adjustable ultrasonic power, and irrigation systems (internal containers and external water sources).
- Principles of Operation: Both operate on the same fundamental principles of ultrasonic scaling.
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable or not specified in the provided 510(k) summary. A 510(k) substantial equivalence submission typically relies on a comparison of device characteristics and intended use, often without requiring new clinical trials or "test sets" in the sense of a new performance study. The data provenance is the device's design specifications and comparison to the predicate.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided and is generally not part of typical 510(k) substantial equivalence submissions for this type of device. There's no mention of a separate "test set" requiring expert ground truth establishment.
4. Adjudication Method
This is not applicable or not specified as there's no mention of a clinical or performance study with a test set requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study is not mentioned in this 510(k) summary. This type of study would typically be used for imaging or diagnostic devices where human reader interpretation is critical, and the AI's impact on that interpretation is being evaluated. An ultrasonic scaler is a therapeutic device where performance is more directly related to its physical capabilities.
6. Standalone (i.e. algorithm only without human-in-the-loop performance) Study
This is not applicable or not specified. While the device contains software, the context is a direct-use medical device (ultrasonic scaler) operated by a human, not an autonomous algorithm. The "software" mentioned controls the delivery of ultrasonic power, not an independent diagnostic or therapeutic function requiring a standalone study.
7. Type of Ground Truth Used
Not explicitly defined in the context of a "ground truth" for a performance study. The "ground truth" for this 510(k) submission is effectively the predicate device's established safety and effectiveness. The Sirona PerioScan demonstrates its "truth" by being sufficiently similar to the already cleared predicate.
8. Sample Size for the Training Set
This is not applicable or not specified. As a substantial equivalence submission for an ultrasonic scaler, the concept of a "training set" for an AI model (in the machine learning sense) is not relevant to the information provided. The device uses software for control, not for learning from data.
9. How the Ground Truth for the Training Set Was Established
This is not applicable or not specified for the same reasons as point 8.
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510(k) Summary for Sirona Dental Systems PerioScan
1. SPONSOR
Sirona Dental Systems GmbH Farbrikstrasse 31 64625 Bensheim Germany
Contact Person: Fritz Kolle Regulatory Manager
Date Prepared: February 11, 2005
2. Device Name
| Proprietary Name: | PerioScan Ultrasonic Scaler |
|---|---|
| Common/Usual Name: | Ultrasonic Scaler |
| Classification Name: | Ultrasonic Scaler |
Predicate Devices ನ್ನೆ
EMS Piezon Master 600 (K022328)
INTENDED USE বা ,
The Sirona PerioScan is an ultrasonic scaler intended for use in the following dental and periodontal applications:
- Removal of supragingival calculus .
- . Removal of subragingival calculus
- . Periodontal therapy
- . Preparing proximal cavities (micropreparation)
- Seating tooth-colored inlays and onlays with highly thixotropic dual . curing cements
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- Root canal irrigation .
- Retrograde root canal treatment .
u DEVICE DESCRIPTION
The Sirona PerioScan Ultrasonic Scaler consists of a table-top unit with two detachable irrigant bottles with lids, a footswitch, an ultrasonic handpiece, hoses and connectors, a variety of optional tips for different dental procedures, and a tool for attaching the tips to the handpiece.
The PerioScan table-top houses the operator input and controls for the supply of irrigant, cooling liquid and light for the handpiece. The device is connected to 115V mains power supply and it may be connected to an external water-supply. The irrigant for the handpiece is drawn from either of the two internal liquid containers or an external water supply. The handpiece is connected to the table-top unit via a hose and can be deposited in the claw. A footswitch with two single switches controls the handpiece. The PerioScan Handpiece is an electrically operated scaler driven by a piezo oscillator. The handpiece includes an illumination LED located in the hose and a spray water controller.
BASIS FOR SUBSTANTIAL EQUIVALENCE 6.
The overall design of the Sirona PerioScan Ultrasonic Scaler 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 on the control unit and delivery of the ultrasonic energy is via a foot control.
The Sirona PerioScan Scaler 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 two internal containers (small and large) or an external water source. Irrigation flow is controlled by handpiece, operator's panel and footswitch for the Sirona PerioScan as well as for the Piezon® Master 600.
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Based on the comparison of intended use and technical features, Sirona Dental Systems believes that the PerioScan is 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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Image /page/3/Picture/2 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the bird symbol.
MAR 2 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Sirona Dental Systems GmbH C/O Ms. Mary McNamara-Cullinane Staff Consultant Medical Devices Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760-4153
Re: K050354
Trade/Device Name: PerioScan Ultrasonic Scaler Regulation Number: 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: February 11, 2005 Received: February 14, 2005
Dear Ms. McNamara-Cullinane:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becatermined 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 Interstate comments or to devices that have been reclassified in accordance with the provisions of Amendinents, or to de reses and Cosmetic Act (Act) that do not require approval of a premarket the Federal I vou, Drag, and Coou may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provided be m 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 (1 Nr.), it may to subject is the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear or roublish further announcements concerning your device in the Eederal Register.
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Page 2 -- Ms. McNamara-Cullinane
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advisou that I Dr. 3 issualled on that your device complies with other requirements mean that I DA nas made a deceminations administered by other Federal agencies. of the Act of ally I edelar statutes and sugments, including, but not limited to: registration You must comply with and the Hotel broq. 21 CFR Part 801); good manufacturing practice and listing (21 CFR Furt 607), laceming (200) regulation (21 CFR Part 820); and if requirents as Sectionic me quality brovisions (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) This letter will anow you to begin mainting of substantial equivalence of your device to a premits that the cation. THE I 27 Pinamages collection 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), IT you desire specific advice for your as 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 may overni other generational and Consumer Assistance at its toll-free Drisker (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Susan Runn
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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510(k) Number (if known):
Koso354
Device Name: PerioScan Ultrasonic Scaler
Indications for Use:
The Sirona Dental Systems PerioScan Ultrasonic Scaler is an ultrasonic scaler intended for use in the following dental and periodontal applications:
- Removal of supragingival and subgingival calculus .
- Periodontal therapy .
- Preparing proximal cavities (micropreparation) .
- Seating tooth-colored inlays and onlays with highly thixotropic dual . curing cements
- Root canal irrigation .
- Retrograde root canal treatment ●
Prescription Use (Part 21 CFR 801 Subpart D) OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Suver Quare
11 300-500 r of Anne Heal logy, General Hospital on Control, Dental Devices
§ 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.