(276 days)
No
The summary describes a mechanical device using a piezoceramic oscillating system and standard electronic controls. There is no mention of AI, ML, image processing, or data analysis that would indicate the use of such technologies.
Yes.
The device is used for removal of calculus, subgingival concretions, endodontic applications, and preparation of tooth enamel, all of which are therapeutic dental procedures.
C_DISPOSITIF_DIAGNOSTIQUE
No
The provided text describes a drive unit for dental procedures that removes calculus, concretions, and prepares tooth enamel. Its function is interventional/therapeutic, not diagnostic.
No
The device description explicitly lists multiple hardware components including a control unit, handpiece, foot control, and power supply, indicating it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for dental procedures performed directly on the patient (removal of calculus, endodontic application, preparation of tooth enamel). This is a therapeutic and procedural use, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a drive unit, handpieces, foot control, and tips used for mechanical action on teeth and surrounding tissues. It does not describe any components or processes for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on laboratory testing.
The device is clearly intended for use in a clinical setting for direct patient treatment, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Drive unit with a piezoceramic oscillating system, which moves the tip in a linear oscillation.
The drive unit is used for the removal of supragival calculus and subgingival concretions and for endodontic application and preparation of tooth enamel.
Product codes (comma separated list FDA assigned to the subject device)
ELC
Device Description
The Proxeo ULTRA is a drive unit including handpieces with a piezoceramic oscillating system, which moves the tip in a linear oscillation.
The drive unit is used for the removal of supragingival calculus and subgingival concretions and for endodontic application and preparation of tooth enamel.
The medical device consists of the following components that are also included in the scope of delivery:
- Control unit (PB-510, PB-520, and PB-530)
- Handpiece (PB-5 L, PB-5 L, S, and PB-5 L Q)
- Foot control (wired, wireless)
- A Power supply, instruction for use and other accessories
The scaler tips are moved with a piezo-scaler handpiece by converting electrical energy into mechanical vibration. The coolant (water) is directed to the treatment site via a solenoid valve and a control unit via the tip. The scaler tips are re-usable [diamond-coated tips are single use only] and delivered non-sterile. Tips for use with Piezo Scaler for the following dental applications:
- Scaling-tips
- Periodontic-tips
- Implant-cleaning-tips
- Endodontic-tips
- Tips for restoration and prosthetics
With the foot control, corresponding device functions can be operated with the foot. These functions include, for example, program selection (button), operation of coolant function (button), motor direction of rotation selection (button), motor speed level (variable with pedal), power piezo handpiece (variable with pedal).
Bluetooth Low Energy technology is used in the wireless foot controls (C-NW) to make this possible wirelessly as well. The foot controls are powered internally by a rechargeable battery (C-NW) or an external power source (C-NF).
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
dentist or dental hygienist
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)
Non-clinical testing has been performed showing that the device performs as intended and are substantially equivalent to the predicate device (K140965) and the reference device (K132445).
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.
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the FDA acronym with the full name of the agency on the right. The FDA part is in blue, with the acronym in a solid blue square and the full name written in a smaller font next to it.
July 14, 2023
W&H Dentalwerk Buermoss GmbH Gerhard Weidler Regulatory Affairs Manager Ignaz-Glaser-Strasse 53 Buermoos, Salzburg 5111 AUSTRIA
Re: K223173
Trade/Device Name: Proxeo ULTRA (PB-510, PB-520 and PB-530) Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: Class II Product Code: ELC Dated: June 21, 2023 Received: June 23, 2023
Dear Gerhard Weidler:
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 (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 located 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.
1
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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-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).
Sincerely.
Michael E. Adjodha -S
Michael E. Adjodha, M.ChE. 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
2
Indications for Use
510(k) Number (if known) K223173
Device Name Proxeo ULTRA (PB-510, PB-520 and PB-530)
Indications for Use (Describe)
Drive unit with a piezoceramic oscillating system, which moves the tip in a linear oscillation.
The drive unit is used for the removal of supragival calculus and subgingival concretions and for endodontic application and preparation of tooth enamel.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 201 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 201 Subpart C) |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary K223173
Image /page/3/Picture/2 description: The image shows the W&H logo, which is a stylized "W&H" inside a rounded, elongated hexagon. To the right of the logo is a green arrow shape containing the text "People have Priority" in white. The text is stacked vertically, with "People" at the top, "have" in the middle, and "Priority" at the bottom.
| DATE PREPARED | July 13, 2023 |
|---|---|
| APPLICANT | W&H Dentalwerk Buermoos GmbH |
| Ignaz-Glaser-Straße 53 | |
| 5111 Bürmoos | |
| Austria | |
| 0043 - 6274/6236-0 | |
| 0043 - 6274/6236-55 | |
| CONTACT PERSON | Mag. Dr. Gerhard Weidler |
| Regulatory Affairs Manager | |
| 0043 - 6274/6236-9339 | |
| gerhard.weidler@wh.com |
1 Device Name:
| Trade Name: | Proxeo ULTRA (PB-510, PB-520 and PB-530) |
|---|---|
| Common Name: | Proxeo ULTRA |
| Device Classification Name: | Ultrasonic scaler |
Classification / Product Code: വ
The Proxeo ULTRA can be classified according to following device name and product code:
| Device | Regulation
Description | Regulation
Medical
Specialty | Review
Panel | Product
Code | Regulation
Number | Device
Classification |
|-----------------------|---------------------------|------------------------------------|-----------------|-----------------|----------------------|--------------------------|
| Scaler,
Ultrasonic | Ultrasonic
scaler | Dental | Dental | ELC | 872.4850 | 2 |
4
Predicate Device / Reference Device: 3
| Device | Predicate
Device | Reference
Device | 510(k)
Number | 510(k) Holder |
|-----------------------|---------------------|---------------------|------------------|-------------------------------------------|
| Scaler,
Ultrasonic | Multipiezo Pro | -------- | K140965 | Mectron Spa |
| | -------- | Piezon 250 | K132445 | E.M.S. ELECTRO
MEDICAL SYSTEMS
S.A. |
4 Device Description:
The Proxeo ULTRA is a drive unit including handpieces with a piezoceramic oscillating system, which moves the tip in a linear oscillation.
The drive unit is used for the removal of supragingival calculus and subgingival concretions and for endodontic application and preparation of tooth enamel.
The medical device consists of the following components that are also included in the scope of delivery:
-
Control unit (PB-510, PB-520, and PB-530)
- Handpiece (PB-5 L, PB-5 L, S, and PB-5 L Q) >
-
Foot control (wired, wireless)
- A Power supply, instruction for use and other accessories
The scaler tips are moved with a piezo-scaler handpiece by converting electrical energy into mechanical vibration. The coolant (water) is directed to the treatment site via a solenoid valve and a control unit via the tip. The scaler tips are re-usable [diamond-coated tips are single use only] and delivered non-sterile. Tips for use with Piezo Scaler for the following dental applications:
- V Scaling-tips
-
Periodontic-tips
- V Implant-cleaning-tips
-
Endodontic-tips
-
Tips for restoration and prosthetics
With the foot control, corresponding device functions can be operated with the foot. These functions include, for example, program selection (button), operation of coolant function (button), motor direction of rotation selection (button), motor speed level (variable with pedal), power piezo handpiece (variable with pedal).
Bluetooth Low Energy technology is used in the wireless foot controls (C-NW) to make this possible wirelessly as well. The foot controls are powered internally by a rechargeable battery (C-NW) or an external power source (C-NF).
5
Indications for Use ട്
Drive unit with a piezoceramic oscillating system, which moves the tip in a linear oscillation.
The drive unit is used for the removal of supragingival calculus and subgingival concretions and for endodontics application and preparation of tooth enamel.
Technological Characteristics 6
The technological characteristics of Proxeo Ultra are the technological characteristics of the predicate device.
| | W&H Dentalwerk
Bürmoos GmbH –
Proxeo Ultra
(New Device) | Mectron Spa–
Multipiezo Pro
(Predicate Device) | EMS Electro Medical
Systems SA –
Piezon 250
(Reference Device) | Result |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Device
Name | Proxeo Ultra | Multipiezo Pro | Piezon 250 | --- |
| Regulation
Number | 872.4850 | 872.4850 | 872.4850 | Identical |
| Class | II | II | II | Identical |
| Product
Code | ELC | ELC | ELC | Identical |
| Regulation
Generic
Name | Ultrasonic scaler | Ultrasonic scaler | Ultrasonic scaler | Identical |
| Indications
for Use | Drive unit with a
piezoceramic
oscillating system,
which moves the tip
in a linear oscillation.
The drive unit is used
for the removal of
supragingival
calculus and
subgingival
concretions and for
endodontic
application and
preparation of tooth
enamel. | The Multipiezo Pro and
Multipiezo are
piezoelectric ultrasonic
dental scalers intended
for use, with the
appropriate associated
tip inserts, in the
following dental
applications:
Scaling: All general
procedures for
removal of
supragingival/subgi
ngival and
interdental
calculus/ plaque
deposits | The Piezon 250 is a
device for delivering
ultrasonic movement
and irrigant to a
stainless-steel tip
which is used by a
dentist or dental
hygienist. The
indications for use
are:
Periodontal
pocket lavage
with
simultaneous
ultrasonic tip
movement | Equivalent |
| | W&H Dentalwerk
Bürmoos GmbH –
Proxeo Ultra
(New Device) | Mectron Spa–
Multipiezo Pro
(Predicate Device) | EMS Electro Medical
Systems SA –
Piezon 250
(Reference Device) | Result |
| | | > Periodontology:
Periodontal
therapy and
debridement for all
types of
periodontal
diseases, including
periodontal pocket
irrigation and
cleaning
Endodontics: All
treatments for root
canal reaming,
irrigation, revision,
filling, gutta-percha
condensation and
retrograde
preparation
Restorative and
Prosthetics: All general
restorative procedures
including cavity
preparation, removal of
prostheses, amalgam
condensation, finishing
of crown preparations,
inlay/onlay
condensation,
implants/restorations
cleaning. | > Scaling and root
planning
Removal of supra
and subgingival
calculus and stains
from teeth | |
| Functions | The basic function is
the conversion of
electrical energy into
mechanical energy
(linear oscillation). | The Multipiezo Pro
device is dental
piezoelectric ultrasonic
device that use
ultrasonic energy to
generate mechanical
micro-vibration of the
inserts to perform the
dental procedures
defined in their
intended use. | Ultrasonic scaling | Identical |
| Sterility | Provided non-sterile | Provided non-sterile | Provided non-sterile | Identical |
| | W&H Dentalwerk
Bürmoos GmbH –
Proxeo Ultra
(New Device) | Mectron Spa–
Multipiezo Pro
(Predicate Device) | EMS Electro Medical
Systems SA –
Piezon 250
(Reference Device) | Result |
| Electric
power
supply | 100-230 V ± 10%
50-60 Hz | 100-240 VAC
50-60 Hz | 100-240 VAC
50-60 Hz | Equivalent |
| Operating
Mode | Continuous
Operation | Continuous Operation | Continuous Operation | Identical |
| Electric
classification | B | B | BF | Equivalent |
| Ultrasonic
frequency | 22-35 kHz | 24-36 kHz | 24-32 kHz | Equivalent |
| Foot control | > wireless
wired | > wired | > wired | Equivalent |
| Components | > Control Unit
Handpiece (in
different versions)
Foot control (in
different versions)
Power supply,
instruction for use
Scaler tips | > Control Unit
Handpiece
Foot control
Power supply
Scaler tips | > Control Unit
Handpiece
Foot control
Instruments
Irrigating liquid
bottle | Equivalent |
6.1 Device Characteristics Table
6
7
6.2 Summary of Technological Characteristics
The proposed devices are similar in terms of design, operating principles and intended use and have similar technological characteristics as the predicate devices. The materials used on these devices are also used in the legally marketed predicate devices.
Performance Data: 7
Non-clinical testing has been performed showing that the device performs as intended and are substantially equivalent to the predicate device (K140965) and the reference device (K132445).
7.1 Biocompatibility
An evaluation of biocompatibility according to ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 10993-12, ISO 10993-17, ISO 10993-18 and ISO 10993-23 was performed.
Electromagnetic Compatibility and Electrical Safety 7.2
Electrical safety and EMC testing were conducted. The Proxeo ULTRA is in compliance with IEC 60601-1, IEC 80601-2-60 as well as IEC 60601-1-2.
8
7.3 Re-processing Validation
Reprocessing validation was provided per the FDA Guidance Document for "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling". Cleaning and intermediate level disinfection validation was provided for the control unit and foot controller. Cleaning and sterilization validation was provided for the scaler tips and handpieces.
7.4 Bench Testing
Functional testing of the Proxeo ULTRA to test the application, settings, and features per the device specifications requirements.
8 Software:
Software verification according to IEC 62304 and the FDA Guidance Document for Software Contained in Medical Device was conducted and the necessary software documentation according to the defined moderate level of concern was provided.
Substantial Equivalence Summary / Conclusion: ி
Based on available 510(k) information provided herein, our Proxeo ULTRA is considered to be substantially equivalent to the predicate device Multipiezo Pro and the reference device Piezon 250 in terms of indication for use, materials and technology, design and performance specifications.