(247 days)
Not Found
No
The device description focuses on mechanical function and electrical energy conversion, with no mention of AI, ML, or related concepts.
No
The device is used for cleaning and polishing tooth surfaces, which are considered cosmetic and maintenance procedures, rather than treating or preventing a disease or condition.
No
Explanation: The "Intended Use" states that the device is for "cleaning and polishing of tooth surfaces and fillings," which describes a therapeutic or maintenance function, not a diagnostic one.
No
The device description explicitly lists multiple hardware components including a drive handpiece, wireless foot controller, handpiece holder, and charger. It also describes the conversion of electrical energy to mechanical motion and mentions a battery.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to perform cleaning and polishing of tooth surfaces and fillings." This is a mechanical action performed directly on the patient's body (specifically, their teeth and fillings).
- Device Description: The device is described as an "electrical drive unit" that converts electrical energy into mechanical rotary motion. This is consistent with a device used for physical manipulation.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information about a physiological state, health, or disease. This device does not interact with or analyze such specimens.
The device is clearly intended for a direct dental procedure, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Battery driven electrical drive unit with wireless foot controller to perform cleaning and polishing of tooth surfaces and fillings.
Product codes (comma separated list FDA assigned to the subject device)
EKX
Device Description
The “PROXEO Twist Cordless Polishing System PL-40 H” is an electrical drive unit for cleaning and polishing tooth surfaces and fillings by use of Disposable Prophy Angles, so-called "DPAs". The system consists of - the cordless drive handpiece PL-40 H, - the wireless foot controller C-NW, - a handpiece holder, and - a charger inclusive adaptor. Its basic function is the conversion of electrical energy into a mechanical rotary motion. Power is supplied by a Li-ion battery, which is assembled in the drive handpiece and can be recharged by means of the provided charging cable. The battery is not changeable by the user. The device's application is intended in dentistry.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tooth surfaces and fillings
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dentistry
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: Type testing according to ISO 14457:2017 “Dentistry – Handpieces and motors" Electrical Safety Tests according to IEC 80601-2-60:2012-02 “Medical electrical equipment – Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment" and IEC 60601- 1:2005, 3rd Ed. + Corr.1:2006 + Corr2:2007 as well as IEC 60601-1: 2012, 3.1 Ed. "Medical electrical equipment – Part: General requirements for safety" Electromagnetic Compatibility Test according to IEC 60601-1-2:2014 “Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements" and FCC 47CFR Part 15 C § 15.247 "Operation within the bands 902-928 MHz, 2400-2483.5 MHz, and 5725-5850 MHz". Safety Tests according to IEC 62133:2012 + Corr1:2013 "Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications". Software validation according to IEC 62304:2006 + A1:2015 "Medical device software – Software life-cycle processes". Usability validation according to IEC 60601-1-6:2010 + A1:2015 “Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability". Biological Assessment / Cytotoxicity Testing according to ISO 10993-1:2009 + Cor 1:2010 "Biological evaluation of medical devices - Part 1: Evaluation and testing" and ISO 7405:2008 + A1:2013 "Dentistry – Evaluation of biocompatibility of medical devices used in dentistry" Reprocessing Tests under consideration of ISO 17664:2017 “Reprocessing of Health Care Products - Information to be provided by the manufacturer for the processing of medical devices” and ANSI/AAMI ST79:2010 + A1:2010 + A2:2011 + A3:2012 + A4:2013 “Comprehensive guide to steam sterilization and sterility assurance in health care facilities” as well as ISO 17665-1:2006 “Sterilization of health care products – Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices” Risk Assessment according to ISO 14971:2007. “Medical devices - Application of risk management to medical devices” Additionally, different further bench tests, such as material tests (reg. chemical resistance), life time tests, torque and functionality test and tests for ensuring the stability of packaging were performed house-internally and confirmed the product's suitability for the use in practice.
Clinical Testing: Clinical performance testing was not conducted. W&H considers the PROXEO Twist Cordless Polishing System PL-40 H to be substantially equivalent to the predicate device listed above.
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
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 24, 2021
W&H Dentalwerk Buermoos GmbH Johann Scharl Manager Regulatory Affairs Ignaz Glaser Strasse 53 Buermoos, Salzburg AT - 5111 Austria
Re: K201703
Trade/Device Name: PROXEO Twist Cordless Polishing System PL-40 H Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: Class I, reserved Product Code: EKX Dated: November 20, 2020 Received: November 27, 2020
Dear Johann Scharl:
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.
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
1
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, M.ChE. Assistant Director DHT1B: Division of Dental 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) K201703
Device Name
PROXEO Twist Cordless Polishing System PL-40 H
Indications for Use (Describe)
Battery driven electrical drive unit with wireless foot controller to perform cleaning and polishing of tooth surfaces and fillings.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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FORM FDA 3881 (7/17)
3
510(k) Summary
K201703
| Submitter | W & H DENTALWERK BÜRMOOS GMBH
Ignaz-Glaser-Strasse 53
A - 5111 Bürmoos
Austria
Tel.: 0043 -6274 / 6236 -297
Fax: 0043 -6274 / 6236 -55 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Registration Number | 9681479 |
| Contact Person | Ing. Johann Georg SCHARL |
| Date of Preparation | Feb. 22, 2021 |
| Device Name | PROXEO Twist Cordless Polishing System PL-40 H |
| Classification Name | Dental Handpiece and Accessories |
| Regulation Number | 872.4200 |
| Regulatory class | I |
| Product Code | EKX |
| Predicate Devices | Device Name: Young INFINITY Cordless Handpiece System
510(k) Number: K171377 (Decision Date: August 20th, 2018)
Manufacturer: Young Dental Manufacturing Co. |
| Device Description | The “PROXEO Twist Cordless Polishing System PL-40 H” is
an electrical drive unit for cleaning and polishing tooth
surfaces and fillings by use of Disposable Prophy Angles, so-
called "DPAs".
The system consists of
- the cordless drive handpiece PL-40 H,
- the wireless foot controller C-NW,
- a handpiece holder, and
- a charger inclusive adaptor.
Its basic function is the conversion of electrical energy into a
mechanical rotary motion. Power is supplied by a Li-ion
battery, which is assembled in the drive handpiece and can
be recharged by means of the provided charging cable. The
battery is not changeable by the user.
The device's application is intended in dentistry. |
| Indications for Use: | Battery driven electrical drive unit with
wireless foot controller to perform
cleaning and polishing of tooth surfaces and fillings. |
4
| | | New device | Predicate
device | Judg-
ment |
|---------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| | Product Designation | PROXEO Twist
Cordless Polishing
System PL-40 H | Young INFINITY
Cordless Handpiece
System | different |
| | 510k number | K201703 | K171377 | different |
| | Manufacturer | W&H Dentalwerk
Buermoos GmbH
Reg. No.: 9681479 | Young Dental
Manufacturing Co.
Reg. No. 1941138 | different |
| | Regulation Number | 21 CFR 872.4200 | 21 CFR 872.4200 | same |
| | Product Code | EKX | EKX | same |
| | Regulatory Class | Class I | Class I | same |
| | Use | RX only | RX only | same |
| Comparison:
Technological
Characteristics | Indications for Use | Battery driven
electrical drive unit with
wireless foot controller
to perform cleaning
and polishing of tooth
surfaces and fillings. | Battery driven electrical
drive unit with wireless
foot controller for use
with disposable
prophylaxis angles in
hygiene operatory to
perform cleaning and
polishing of tooth
surfaces and fillings. | equivalent |
| | appearance | Image: PROXEO Twist Cordless Polishing System PL-40 H | Image: Young INFINITY Cordless Handpiece System | equivalent
(different
marking) |
| | Handpiece drive | PL-40 H | (PL-40 H) | (same) |
| | Battery type: | Li-Ion | Li-Ion | same |
| | Runtime: | 8 treatments with a
polishing duration of 6
min. | 8 treatments with a
polishing duration of 6
min. | same |
| | Standby: | automatically after 4
min. | automatically after 4
min. | same |
| | Charging time: | approx. 2 h | approx. 2 h | same |
| | Rated voltage: | 3,7 V | 3,7 V | same |
| | Rated capacity: | 680 mAh | 680 mAh | same |
| | Max. speed: | 3.000 rpm | 3.000 rpm | same |
| | Maximum torque: | 2 Ncm | 2 Ncm | same |
| | Dimensions
(W x D x H): | 160 x 25 x 28 mm | 160 x 25 x 28 mm | same |
| | Weight: | 118 g | 118 g | same |
| | | New device | Predicate
device | Judg-
ment |
| | Foot control | C-NW | (C-NW) | (same) |
| | Battery type: | Li-ion | Li-ion | same |
| | Runtime: | approx. 2 months | approx. 2 months | same |
| | Standby: | automatically if not
actuated | automatically if not
actuated | same |
| Comparison: | Charging time: | approx. 3 h | approx. 3 h | same |
| | Rated voltage: | 3.7 V | 3.7 V | same |
| Technological
Characteristics | Rated capacity: | 680 mAh | 680 mAh | same |
| | Dimensions (WxDxH): | 117 x 117 x 38 mm | 117 x 117 x 38 mm | same |
| | Weight: | 190 g | 190 g | same |
| | Charger:
Rated voltage: | 100 - 240 V | 100 - 240 V | same |
| | Permissible voltage
fluctuation: | $\pm$ 10 % | $\pm$ 10 % | same |
| | Frequency: | 50 - 60 Hz | 50 - 60 Hz | same |
| | Power: | 7 VA | 7 VA | same |
| Comparison:
New device
versus
Predicate device | The target field of application, the intended use, performance parameter and
material are the same or, at least, quite similar to those of the predicate device.
The differences are restricted to the devices' labelling: the type designations and
the devices' as well as their manufacturers' names are differently indicated on the
products themselves, on their packaging, Instructions for Use, etc.
Seen from the technological point of view, the products are identical.
The above-mentioned differences do not have any negative effect on the
substantial equivalence.
Therefore, the new device is substantially equivalent to the predicate device. | | | |
5
6
| Non-clinical testing | Type testing according to
ISO 14457:2017 “Dentistry – Handpieces and motors"
Electrical Safety Tests according to
IEC 80601-2-60:2012-02 “Medical electrical equipment – Part
2-60: Particular requirements for the basic safety and
essential performance of dental equipment"
and
IEC 60601- 1:2005, 3rd Ed. + Corr.1:2006 + Corr2:2007
as well as
IEC 60601-1: 2012, 3.1 Ed.
"Medical electrical equipment – Part: General requirements
for safety" |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Electromagnetic Compatibility Test according to
IEC 60601-1-2:2014 “Medical electrical equipment - Part 1-2:
General requirements for basic safety and essential
performance - Collateral standard: Electromagnetic
compatibility - Requirements"
and
FCC 47CFR Part 15 C § 15.247 "Operation within the bands
902-928 MHz, 2400-2483.5 MHz, and 5725-5850 MHz" |
| | Safety Tests according to
IEC 62133:2012 + Corr1:2013 "Secondary cells and batteries
containing alkaline or other non-acid electrolytes - Safety
requirements for portable sealed secondary cells, and for
batteries made from them, for use in portable applications" |
| | Software validation according to
IEC 62304:2006 + A1:2015 "Medical device software –
Software life-cycle processes". |
| | Usability validation according to
IEC 60601-1-6:2010 + A1:2015 “Medical electrical equipment
– Part 1-6: General requirements for basic safety and
essential performance - Collateral standard: Usability" |
| | Biological Assessment / Cytotoxicity Testing according to
ISO 10993-1:2009 + Cor 1:2010 "Biological evaluation of
medical devices - Part 1: Evaluation and testing"
and
ISO 7405:2008 + A1:2013 "Dentistry – Evaluation of
biocompatibility of medical devices used in dentistry" |
| Non-clinical testing | Reprocessing Tests under consideration of
ISO 17664:2017 “Reprocessing of Health Care Products -
Information to be provided by the manufacturer for the
processing of medical devices”
and
ANSI/AAMI ST79:2010 + A1:2010 + A2:2011 + A3:2012 +
A4:2013 “Comprehensive guide to steam sterilization and
sterility assurance in health care facilities”
as well as
ISO 17665-1:2006 “Sterilization of health care products –
Moist heat - Part 1: Requirements for the development,
validation and routine control of a sterilization process for
medical devices”
Risk Assessment according to
ISO 14971:2007. “Medical devices - Application of risk
management to medical devices”
Additionally, different further bench tests, such as material
tests (reg. chemical resistance), life time tests, torque and
functionality test and tests for ensuring the stability of
packaging were performed house-internally and confirmed
the product's suitability for the use in practice. |
| Clinical Testing | Clinical performance testing was not conducted.
W&H considers the PROXEO Twist Cordless Polishing
System PL-40 H to be substantially equivalent to the
predicate device listed above. |
| Conclusion | This conclusion is based on the similarities in intended use,
principles of operation, functional design and structure.
Differences between the devices shown in the comparison
section above are minor and do not have any negative effect
on equivalence. |
7