(329 days)
No
The description details a pneumatic drive system with a speed sensor and control module that regulates air pressure to maintain constant speed. This is a feedback control system based on a sensor and pre-programmed logic, not AI/ML. There are no mentions of AI, ML, or related concepts in the document.
No
The device is a pneumatic drive system for dental handpieces and air motors used in general dental applications for material removal, preparations, finishing, polishing, prophylaxis, and endodontics. It is an instrument used to perform a procedure rather than providing or delivering a therapeutic effect.
No
Explanation: The device description clearly states its purpose is for "dental transmission instruments" used in various dental procedures like "removal of decayed materials, cavities and crown preparations, removal of filings, finishing of tooth and restauration surfaces, polishing, prophylaxis and endodontics." These are all treatment-oriented functions, not diagnostic ones. There is no mention of the device being used to identify, detect, or analyze conditions or diseases.
No
The device description explicitly states the system consists of a control unit (AC-1.0) and air-driven handpieces/motors, which are hardware components. The software validation mentioned is for the software within this hardware system, not a standalone software 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 clearly describes a system for driving dental handpieces and air motors for procedures performed directly on the patient's teeth and mouth (removal of decayed materials, cavity preparation, polishing, etc.). This is a direct clinical application, not an in vitro test.
- Device Description: The description details a pneumatic drive system, control unit, handpieces, and air motors. These are all components used for mechanical manipulation within the oral cavity.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or performing tests outside of the body. The device's function is to power tools for dental procedures.
Therefore, this device falls under the category of a dental device used for direct patient treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Pneumatic drive system for dental handpieces and dental air motors, which is intended to be used in general dental applications such as: removal of decayed materials, cavities and crown preparations, removal of filings, finishing of tooth and restauration surfaces, polishing, prophylaxis and endodontics.
Product codes (comma separated list FDA assigned to the subject device)
EFB
Device Description
The Advanced Air System is intended for dental transmission instruments used in the field of preventive dentistry, restorative dentistry such as cavity preparation and prosthodontics such as crown preparation and endodontics.
The system consists of the control unit (AC-1.0), which is designed to be built in a dental chair. As an attachment the air-driven handpiece (RK-97 L, RG-97 L, and/or RK-94 L) or the air motor (RM-25 L RM) can be used.
The air-driven handpiece is equipped with a speed sensor, which is connected to a control module that regulates the applied air pressure to the handpiece through a proportional valve in order to maintain constant speed throughout the dental treatment.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Electrical Safety Tests according to IEC 60601-1:2005, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
Electromagnetic Compatibility Test according to IEC 60601-1-1:2007: General requirement for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
Product testing of handpiece function and life cycle testing were performed per ISO 14457:2012: Dentistry - Handpieces and Motors. The results demonstrate substantial equivalence in this regard.
Software validation according to IEC 62304:2006: Medical device software - Part 1: Guidance on the application of ISO 14972 to medical device software
Usability validation according to the standard IEC 62366:2007
Thermal safety according to the standard IEC 62471:2006: Photobiological safety of lamps and lamp systems
Evaluation of biocompatibility is based upon the fact that patient contacting materials in the subject handpiece are identical to those in the previously W&H TA-97LED and AM-25L RM handpieces, which, as handpieces, present the same level and duration of contact. In addition, Cytotoxicity Testing per EN ISO 10993-5:2009-06 was performed. This evaluation meets the requirements of ISO 7405:2008 for preclinical evaluation of biocompatibility of dental devices.
Clinical data were not needed for this new product.
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
§ 872.4200 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
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 23, 2015
W & H Dentalwerk Buermoos GmbH Mag. Anja Lindner Manager Regulatory Affairs Ignaz-Glaser-Strasse 53 A 5111 Buermoos AUSTRIA
Re: K143704
Trade/Device Name: Advanced Air System Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: October 12, 2015 Received: October 14, 2015
Dear Mag. Anja Lindner:
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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina Kiang -S
for Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/0 description: The image shows a logo with the text "W&H" inside a gray, rounded hexagon. Above the logo is a green banner with the text "PEOPLE HAVE PRIORITY" in white letters. The logo appears to be for a company or organization that values people.
510(k) Indications for Use Statement
Indications for Use
| 510(k) number: | K143704 |
|---|---|
| Device Name: | Advanced Air System |
| Indication for Use: | Pneumatic drive system for dental handpieces and dental air |
| motors, which is intended to be used in general dental | |
| applications such as: removal of decayed materials, cavities and | |
| crown preparations, removal of filings, finishing of tooth and | |
| restauration surfaces, polishing, prophylaxis and endodontics. |
| Prescription Use
| (Part 21 CFR 801 Subpart D) | X |
|---|---|
| ------------------------------------------------- | --- |
AND/OR
Over The Counter Use (Part 21 CFR 807 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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510(k) SUMMARY
| Applicant and
Owner | W & H DENTALWERK BÜRMOOS GMBH
Ignaz-Glaser-Strasse 53
A - 5111 Bürmoos
Austria
Tel.: 0043 -6274 / 6236 -397
Fax: 0043 -6274 / 6236 -55 |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Registration
Number | 9681479 |
| Contact
Person | Mag. Anja LINDNER |
| Date of
Submission | 19th of December, 2014 |
| Device Name | Advanced Air System |
| Classification
Name | Handpiece, Air-powered, Dental |
| Regulation
Number | 21 CFR 872.4200 class 1 reserve |
| Product Code | EFB |
| Predicate
Devices | Primary Predicate:
"Axis System", Dentsply / York, PA; cleared under K072989
Reference Predicates:
"A-dec/W&H Synea Air-Driven Highspeed Handpiece and Attachment",
W&H Dentalwerk, Bürmoos; cleared under K070663
"A-dec/W&H Alegra Air-Driven Highspeed Handpiece and Attachment",
W&H Dentalwerk, Bürmoos; cleared under K082716 |
| Device
Description | The Advanced Air System is intended for dental transmission instruments used in
the field of preventive dentistry, restorative dentistry such as cavity preparation and
prosthodontics such as crown preparation and endodontics.
The system consists of the control unit (AC-1.0), which is designed to be built in
a dental chair. As an attachment the air-driven handpiece (RK-97 L, RG- 97 L,
and/or RK-94 L) or the air motor (RM-25 L RM) can be used.
The air-driven handpiece is equipped with a speed sensor, which is connected to a
control module that regulates the applied air pressure to the handpiece through a
proportional valve in order to maintain constant speed throughout the dental
treatment. |
4
Image /page/4/Picture/0 description: The image shows a logo with the letters "W&H" inside a gray, rounded octagon. Above the logo, there is a green banner with the text "PEOPLE HAVE PRIORITY" in white letters. The logo appears to be for a company or organization that values its people.
Advanced Air System
510(k) Summary
| Indication for
Use: | Pneumatic drive system for dental handpieces and dental air motors, which is
intended to be used in general dental applications such as: removal of decayed
materials, cavities and crown preparations, removal of filings, finishing of tooth and
restauration surfaces, polishing, prophylaxis and endodontics. | | | | |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|-------------------------------------------------------------------------------|---------------------------|----------------------------------------------------------|
| | Control unit: | | | | |
| | Technological
characteristic | Subject device | Predicate Device
Axis System
(K072989) | | |
| | User modes (control
characteristics) | 3 | 1 | | |
| | Supply air | 0.52 – 0.59 MPa
(75 – 85 psi) | 0.45 – 0.52 MPa
(65 – 75 psi) | | |
| | Power supply | 19–29 V AC @ 50-60Hz
or 24-40 V DC | 24 V DC | | |
| Technological
Characteristics | The subject device and the predicate device, both contain a proportional air valve
which regulates the amount of air flow to the straight air-powered handpiece or
airmotor according to the received speed signal.
Both devices are equipped with a speed sensor. The speed sensor of the subject
device is positioned in the head area - therefore the speed is directly measured
where the rotation occurs.
The speed sensor of the predicate device is positioned in the coupling area where
it measures the frequency of vibrations of the rotating bur and concludes to the
speed.
Straight air-powered Handpieces and Air Motor: | | | | |
| | Technological
characteristic | Subject devices
(RK-97L, RG-97 L, RK-94 L, RM-
25 L RM) | Reference Predicate
Devices
TA-97 LED, AM-25 L RM
(K070663, K082716) | | |
| | Optic lighting | yes | yes | | |
| | Speed range | RK/RG-97 L:
RK-94 L:
RM-25 L RM: | 60,000–320,000 rpm
60,000–320,000 rpm
2,000-20,000 rpm | TA-97 LED:
AM-25 L RM: | 400,000 rpm
5,000–25,000 rpm |
| | Max. torque | RK/RG-97 L:
RK-94 L:
RM-25 L RM: | 2.4 Nmm (0.34 ozf in)
1.5 Nmm (0.21 ozf in)
4.4 Nmm (6.2 ozf in) | TA-97 LED: | 1.7 Nmm (0.25 ozf in)
AM-25 L RM: 24 Nmm (3,4 ozf in) |
| | Max. power | RK/RG-97 L:
RK-94 L:
RM-25 L RM: | 30 W
20 W
28 W | TA-97 LED:
AM-25 L RM: | 18 W
16 W |
| | Toque limit | | 30 - 100 % | | None |
| | Max. air
consumption | RK/RG-97 L:
RK-94 L:
RM-25 L RM: | 1.2 l/s (2.5 cfm)
1.1 l/s (2.3 cfm)
1.5 l/s (3.2 cfm) | TA-97 LED:
| 0.75 l/s (1.5 cfm)
1 l/s (2.1 cfm) |
| | Weight | RK/RG-97 L: | 38 g (1.34 oz) | TA-97 LED: | 38 g (1.34 oz) |
5
Advanced Air System
| | The subject device includes a speed sensor; the other aspects of the construction
of the subject device and the predicate device are identical.
The technical principle is the same as within the predicate device.
The main technological characteristics are the same or, at least, quite similar to
those of the comparable product. |
|-----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison of
the device to
the predicate
device | The target field of application, the intended use, functions and technological
features, performance parameter and material are the same or, at least, quite
similar to those of the predicate device.
The product comparison did not raise new or different questions of equivalence.
The new device is substantially equivalent to the predicate device. |
| Performance
Testing | Electrical Safety Tests according to IEC 60601-1:2005, Medical
electrical
equipment - Part 1: General requirements for basic safety and
essential
performance.
Electromagnetic Compatibility Test according to IEC 60601-1-1:2007: General
requirement for basic safety and essential performance - Collateral standard:
Electromagnetic compatibility - Requirements and tests
Product testing of handpiece function and life cycle testing were performed per ISO
14457:2012: Dentistry - Handpieces and Motors. The results demonstrate
substantial equivalence in this regard.
Software validation according to IEC 62304:2006: Medical device software -
Part 1: Guidance on the application of ISO 14972 to medical device software
Usability validation according to the standard IEC 62366:2007
Thermal safety according to the standard IEC 62471:2006: Photobiological safety
of lamps and lamp systems
Evaluation of biocompatibility is based upon the fact that patient contacting
materials in the subject handpiece are identical to those in the previously W&H
TA-97LED and AM-25L RM handpieces, which, as handpieces, present the
same level and duration of contact. In addition, Cytotoxicity Testing per EN ISO
10993-5:2009-06 was performed. This evaluation meets the requirements of
ISO 7405:2008 for preclinical evaluation of biocompatibility of dental devices. |
| Clinical
Testing | Clinical data were not needed for this new product. |
6
| | Advanced Air System
510(k) Summary | Section 5
Page 4 of 3 |
|------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|
| Conclusion | W&H considers the Advanced Air System to be substantially equivalent to the
predicate devices listed above. This conclusion is based on the similarities in
intended use, principles of operation, functional design, and established medical
use. Differences between the devices shown in the side-by-side comparison table
above are minor and do not have any negative effect on equivalence.
The “Advanced Air System”, as designed and manufactured, is substantially
equivalent to its predicate device. | |