(98 days)
No
The description focuses on the mechanical operation of the device (generating high-frequency waves for vibration) and standard electrical and software performance testing, with no mention of AI, ML, or related concepts.
Yes
The intended use of the device includes "Periodontal therapy," which is a form of medical treatment aimed at addressing issues related to the gums and supporting structures of the teeth. Therapeutic devices are used to treat medical conditions or diseases.
No
Explanation: The device is an ultrasonic scaler used for scaling and periodontal therapy (treatment), not for diagnosing conditions.
No
The device description explicitly lists hardware components such as the main unit, handpiece, footswitch, removable sheath, and scaler inserts, and describes the physical mechanism of generating high-frequency waves. While software verification is mentioned, the device is clearly a physical medical device with integrated software, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The BioSonic US200 Ultrasonic Scaler is used for scaling and periodontal therapy directly on the patient's teeth and gums (sub-gingival and supra-gingival). It uses ultrasonic vibrations to remove plaque and calculus.
- Lack of Specimen Analysis: The device does not analyze any specimens taken from the body. It is a therapeutic and prophylactic device used for direct treatment.
The description clearly indicates its use in dental procedures performed directly on the patient, not on samples in a laboratory setting.
N/A
Intended Use / Indications for Use
Ultrasonic Applications for:
- All sub-gingival and supra-gingival scaling and routine prophylaxis procedures.
- Periodontal therapy
Product codes
ELC
Device Description
The BioSonic US200 Ultrasonic Scaler is an ultrasonic scaling unit that is used in sub-gingival and supra-gingival scaling and routing prophylaxis procedures, and periodontal therapy. The BioSonic US200 Ultrasonic Scaler includes the main unit, handpiece, footswitch, removable sheath, and a selection of scaler inserts. This device generates high frequency waves that cause the tip of the scaler insert to vibrate at 25kHz or 30kHz depending on the scaler insert used.
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
Not Found
Intended User / Care Setting
Not Found
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
Performance testing was conducted to verify that the proposed BioSonic US200 Ultrasonic Scaler meets the requirements of IEC 60601-1 and IEC 60601-1-2. Software verification of the device were conducted in accordance with the FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" Performance Testing – Bench, of this Premarket Submission, contains detailed information regarding the proposed BioSonic Scaler including testing protocols, test objectives, test articles, test methods and procedures, and acceptance criteria.
Non-clinical tests performed to establish substantial equivalence to the including frequency testing. power testing, tip displacement testing, insert extraction testing and, and materials compatibility testing with cleaning and disinfecting agents.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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July 1, 2024
Dent4You AG Tricia Cregger Global Regulatory Affairs Manager Bahnhofstrasse 2 Heerbrugg, 9435 SWITZERLAND
Re: K240801
Trade/Device Name: BioSonic US200 Ultrasonic Scaler (60034537) Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: Class II Product Code: ELC Dated: March 22, 2024 Received: March 25, 2024
Dear Tricia Cregger:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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Sincerely,
Michael E. Adjodha -S
Michael E. Adjodha, MChE, RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
BioSonic US200 Ultrasonic Scaler (60034537)
Indications for Use (Describe)
Ultrasonic Applications for:
-
All sub-qingival and supra-qingival scaling and routine prophylaxis procedures.
-
Periodontal therapy
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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| 510(k) #: | K240801 | 510(k) Summary | Prepared on: 2024-06-26 |
|---|---|---|---|
| ----------- | --------- | ---------------- | ------------------------- |
| Contact Details | 21 CFR 807.92(a)(1) | ||
|---|---|---|---|
| Applicant Name | Dent4You AG | ||
| Applicant Address | Bahnhofstrasse 2 Heerbrugg 9435 Switzerland | ||
| Applicant Contact Telephone | 330-916-8904 | ||
| Applicant Contact | Dr. Tricia Cregger | ||
| Applicant Contact Email | tricia.cregger@coltene.com | ||
| Device Name | 21 CFR 807.92(a)(2) | ||
| Device Trade Name | BioSonic US200 Ultrasonic Scaler (60034537) | ||
| Common Name | Ultrasonic scaler | ||
| Classification Name | Scaler, Ultrasonic | ||
| Regulation Number | 872.4850 | ||
| Product Code(s) | ELC | ||
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | ||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | |
| K983727 | BioSonic Ultrasonic Scaler System | ELC | |
| Device Description Summary | 21 CFR 807.92(a)(4) | ||
| The BioSonic US200 Ultrasonic Scaler is an ultrasonic scaling unit that is used in sub-gingival and supra-gingival scaling and routing prophylaxis procedures, and periodontal therapy. The BioSonic US200 Ultrasonic Scaler includes the main unit, handpiece, footswitch, removable sheath, and a selection of scaler inserts. This device generates high frequency waves that cause the tip of the scaler insert to vibrate at 25kHz or 30kHz depending on the scaler insert used. | |||
| Intended Use/Indications for Use | 21 CFR 807.92(a)(5) | ||
| Ultrasonic Applications for: |
- All sub-gingival and supra-gingival scaling and routine prophylaxis procedures.
- Periodontal therapy | | | |
| Indications for Use Comparison | | | 21 CFR 807.92(a)(5) |
| The indications for use of the BioSonic US200 Ultrasonic Scaler are identical to the indicatrions for use of the predicate device, the BioSonic Ultrasonic Scaler System. | | | |
| Technological Comparison | | | 21 CFR 807.92(a)(6) |
| The BioSonic US200 Ultrasonic Scaler (subject device) and the BioSonic Ultrasonic Scaler System are both ultrasonic scalers for sub-gingival and supra-gingival scaling and routine prophylaxis procedures and periodontal therapy. The indications for use are identical and the technological characteristics are substantially equivalent with only minor differences, including the mechanism to change from | | | |
and the technological characteristics are substantially equivalent with only minor differences, including the mechanism to change from NORMAL to Turbo Mode, the automatic frequency detection of the scaler insert, and the removable autoclavable sheath. These minor differences do not constitute a new intended use or raise different questions of safety and effectiveness compared with the predicate
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Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Performance testing was conducted to verify that the proposed BioSonic US200 Ultrasonic Scaler meets the requirements of IEC 60601-1 and IEC 60601-1-2. Software verification of the device were conducted in accordance with the FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" Performance Testing – Bench, of this Premarket Submission, contains detailed information regarding the proposed BioSonic Scaler including testing protocols, test objectives, test articles, test methods and procedures, and acceptance criteria.
Non-clinical tests performed to establish substantial equivalence to the including frequency testing. power testing, tip displacement testing, insert extraction testing and, and materials compatibility testing with cleaning and disinfecting agents.
Not Applicable
Based on the non-clinical performance data the proposed BioSonic Scaler is as safe, as effective, and performs as well as or better than the predicate device BioSonic Scaler system (K983727, 21 CFR 872.4850, product code ELC.)