(35 days)
Not Found
No
The device description details a standard ultrasonic scaler with mechanical and electrical components, and there is no mention of AI or ML in the intended use, device description, or the "Mentions AI, DNN, or ML" section.
Yes
The 'Intended Use / Indications for Use' section explicitly mentions 'Periodontal therapy' as an intended application, which is a therapeutic treatment.
No.
The device is described as an ultrasonic scaler used for dental and periodontal applications such as calculus removal and root canal irrigation, not for diagnosing conditions.
No
The device description clearly outlines multiple hardware components including a table-top unit, handpiece, footswitch, bottles, hoses, and tips. It is an ultrasonic scaler, which is a physical device.
Based on the provided information, the Sirona Dental Systems PerioScan Ultrasonic Scaler is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The intended uses listed for the PerioScan are all procedures performed directly on the patient's teeth and gums (removal of calculus, periodontal therapy, preparing cavities, seating inlays/onlays, root canal irrigation/treatment).
- The device description focuses on mechanical and electrical components for generating ultrasonic vibrations and delivering irrigant, not on analyzing biological samples.
- There is no mention of analyzing blood, urine, tissue, or any other bodily fluid or sample.
Therefore, the Sirona PerioScan Ultrasonic Scaler is a dental device used for therapeutic and procedural purposes, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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
- Root canal irrigation .
- Retrograde root canal treatment .
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 .
- Retrocanal treatment ●
Product codes (comma separated list FDA assigned to the subject device)
ELC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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).
Not Found
§ 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.
0
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
1
- 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.
2
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.
3
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.
4
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