(127 days)
Not Found
No
The device description and performance studies focus on mechanical and electrical components (air-powered handpieces, motors, couplings, LED lights) and standard safety/performance testing (ISO standards, EMC, thermal safety, biocompatibility). There is no mention of software, algorithms, data processing, or any features indicative of AI/ML.
No.
The device description and intended uses (removal of decayed materials, cavity and crown preparation, removal of fillings, finishing of tooth and restoration surfaces) indicate it is a dental tool used for mechanical procedures rather than a device that provides therapy or treatment for a disease or condition.
No
Explanation: The device description and intended use clearly state that this is a dental handpiece used for physical procedures like removal of decayed materials, filling removal, and finishing/polishing, rather than diagnosing conditions.
No
The device description explicitly lists multiple hardware components including handpieces, motors, couplings, and attachments, some of which contain integrated circuit boards and LED light systems. The performance studies also focus on hardware testing (function, lifecycle, EMC, thermal safety, biocompatibility).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes procedures performed directly on the patient's teeth and restoration surfaces (removal of materials, cavity preparation, finishing, polishing). This is a therapeutic and restorative function, not a diagnostic one.
- Device Description: The device description details mechanical components (turbines, motors, attachments, pipes for air and water) and an optional LED light. These are tools for physical manipulation of dental structures.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, tissue, or saliva) or to provide information about a patient's health status or disease.
- Performance Studies: The performance studies focus on mechanical function, safety (EMC, thermal, biocompatibility), and lifecycle testing, which are typical for dental instruments used in treatment. There are no studies related to diagnostic accuracy or performance.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The turbine handpiece is intended for the following applications: Removal of decayed materials, cavities and crown preparation, removal of fillings, finishing of tooth and restoration surfaces.
The dental handpiece/contra-angle is intended for the following applications: Removal of decayed materials, cavities and crown cement, removal of fillings, finishing and polishing of tooth and restoration surfaces.
Product codes (comma separated list FDA assigned to the subject device)
EFB
Device Description
The Air-Powered Handpieces and the Handpiece Attachments are reusable, ergonomically shaped and some of them include LED light system.
The submission is comprised of:
• The W&H Synea Vision/Fusion Air-Powered Handpieces:
TK-100 L, TK-100 LM, TK-98 L, TK-98 LM, TK-97 L, TK-97 LM, TK-94 L, TK-94 LM, TG-97, TG-97 L, TG-97 LM, TG-97 L RM, TG-97 L N, TG-98, TG-98 L RM, TG-98 LM, TG-98 L N
• The W&H Alegra Air-Powered Handpieces:
TE-97 LQ, TE-98 LQ, TE-95 RM, TE-97, TE-97 RM, TE-98, TE-98 RM
• The W&H Air Motors:
AM-25 A RM, AM-25 E RM, AM-25 RM, AM-20 E RM, AM-20 RM
• The W&H Roto Quick couplings:
RQ-04, RQ-14, RQ-24, RQ-34, RQ-54, RM-34 LED G
• The W&H Synea Fusion Handpiece Attachments:
HG-43 A, WG-56 LT, WG-56 A, WG-66 LT, WG-66 A, WG-99 LT, WG-99 A
• The W&H Synea Vision Handpiece Attachments:
HK-43 LT, WK-99 LT, WK-99 LT S, WK-93 LT S, WK-93 LT, WK-56 LT, WK-56 LT S, WK-66 LT, WK-66 LT S
• The W&H Alegra Handpiece Attachments:
HE-43, HE-43 T, WE-56, WE-57, WE-57 T, WE-56 LED G, WE-66 LED G, WE-99 LED G
The Air-powered Handpieces contain pipes inside which supply air for driving the turbine's impeller as well as supply air and water for creating spray exhausting through 3, 4 or 5 ports located in the handpiece's head and intended for cooling the working area as well as the rotating bur. Depending on the type of handpiece – the handle might contain an integrated circuit board and wire bundles, for supplying current and voltage to a head-sided assembled LED light source.
The Handpiece Attachments also contain pipes inside which supply air and water for spray exhausting and for cooling the working area as well as the rotating bur.
Depending on the type of handpiece – the handle might contain an integrated circuit board and wire bundles, for supplying current and voltage to a head-sided assembled LED light source.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth/teeth
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)
Product testing of the handpieces function and life cycle testing were performed according to ISO 14457:2012: Dentistry – Handpieces and Motors. The results demonstrate substantial equivalence in this regard. EMC Testing according to IEC 60601-1-2:2007 Medical electrical equipment Part 1-2 General requirements... Electromagnetic Compatibility 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 cleared predicates (K143704 and K070663), which as handpieces and handpiece attachments, present the same level and duration of contact. In addition, Cytotoxicity Testing per EN ISO 10993-5:2009 was performed. This evaluation meets the requirements of ISO 7405:2008 for preclinical evaluation of biocompatibility of dental devices. Various functionality and lifecycle tests as well as further bench tests demonstrate substantial equivalence.
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.
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other, with flowing lines representing hair or movement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 23, 2017
W&H Dentalwerk Bürmoos GmbH Anja Lindner Mag., Regulatory Affairs Ignaz-Glaser-Straße 53 Bürmoos. Salzburg 5111 Austria
Re: K162926
Trade/Device Name: W&H Air-Powered Handpieces And Handpiece Attachments Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: Class I Product Code: EFB Dated: January 20, 2017 Received: January 25, 2017
Dear 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.
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
1
the quality systems (OS) 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,
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting 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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Indications for Use
510(k) number:
Device Name:
W&H Air-Powered Handpieces and Handpiece Attachments
Indication for Use:
The turbine handpiece is intended for the following applications: Removal of decayed materials, cavities and crown preparation, removal of fillings, finishing of tooth and restoration surfaces.
The dental handpiece/contra-angle is intended for the following applications: Removal of decayed materials, cavities and crown cement, removal of fillings, finishing and polishing of tooth and restoration surfaces.
Prescription Use _ (Part 21 CFR 801 Subpart D) 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
| Submitter | W & H DENTALWERK BÜRMOOS GMBH
Ignaz-Glaser-Strasse 53
A - 5111 Bürmoos
Austria
Tel.: 0043 -6274 / 6236 -397
Fax: 0043 -6274 / 6236 -35 |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Registration Number | 9681479 |
| Contact Person | Mag. Anja LINDNER |
| Date of Submission | 23rd of February, 2017 |
| Device Name | W&H Air-Powered Handpieces and Handpiece Attachments |
| Classification Name | Dental handpiece and accessories |
| Usual/Common Name | Handpiece, Air-Powered, Dental |
| Regulation Number | 21 CFR 872.4200 |
| Regulatory class | I |
| Product Code | EFB |
| Predicate Devices | Primary Predicate:
"Advanced Air System", W&H Dentalwerk Bürmoos GmbH;
cleared under K143704.
Reference Predicates:
"A-dec/W&H Synea Air-Driven Highspeed Handpiece,
"A-dec/W&H Synea Handpiece Attachment" cleared under
K070663
The predicates have not been subject to a design-related
recall. |
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W&H Air-Powered Handpieces and
Handpiece Attachments 510(k) Summary
| 510(k) Summary | |
|---|---|
| Device | |
| Description | |
| and | |
| Technological | |
| Characteristics | The Air-Powered Handpieces and the Handpiece |
| Attachments are reusable, ergonomically shaped and | |
| some of them include LED light system. | |
| The submission is comprised of: | |
| • The W&H Synea Vision/Fusion Air-Powered | |
| Handpieces: | |
| TK-100 L, TK-100 LM, TK-98 L, TK-98 LM, TK-97 L, TK-97 LM, | |
| TK-94 L, TK-94 LM, TG-97, TG-97 L, TG-97 LM, TG-97 L RM, TG- | |
| 97 L N, TG-98, TG-98 L RM, TG-98 LM, TG-98 L N | |
| • The W&H Alegra Air-Powered Handpieces: | |
| TE-97 LQ, TE-98 LQ, TE-95 RM, TE-97, TE-97 RM, TE-98, TE-98 | |
| RM | |
| • The W&H Air Motors: | |
| AM-25 A RM, AM-25 E RM, AM-25 RM, AM-20 E RM, AM-20 RM | |
| • The W&H Roto Quick couplings: | |
| RQ-04, RQ-14, RQ-24, RQ-34, RQ-54, RM-34 LED G | |
| • The W&H Synea Fusion Handpiece | |
| Attachments: | |
| HG-43 A, WG-56 LT, WG-56 A, WG-66 LT, WG-66 A, WG-99 LT, | |
| WG-99 A | |
| • The W&H Synea Vision Handpiece | |
| Attachments: | |
| HK-43 LT, WK-99 LT, WK-99 LT S, WK-93 LT S, WK-93 LT, WK- | |
| 56 LT, WK-56 LT S, WK-66 LT, WK-66 LT S | |
| • The W&H Alegra Handpiece Attachments: | |
| HE-43, HE-43 T, WE-56, WE-57, WE-57 T, WE-56 LED G, WE-66 | |
| LED G, WE-99 LED G | |
| The Air-powered Handpieces contain pipes inside which | |
| supply air for driving the turbine's impeller as well as | |
| supply air and water for creating spray exhausting | |
| through 3, 4 or 5 ports located in the handpiece's head | |
| and intended for cooling the working area as well as the | |
| rotating bur. Depending on the type of handpiece – the | |
| handle might contain an integrated circuit board and wire | |
| bundles, for supplying current and voltage to a head- | |
| sided assembled LED light source. |
The Handpiece Attachments also contain pipes inside
which supply air and water for spray exhausting and for
cooling the working area as well as the rotating bur.
Depending on the type of handpiece – the handle might
contain an integrated circuit board and wire bundles, for |
5
| PEOPLE HAVE PRIORITY | ||
|---|---|---|
| 1 |
W&H Air-Powered Handpieces and Handpiece Attachments 510(k) Summary
| | supplying current and voltage to a head-sided assembled
LED light source. | | | | |
|-----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|--|
| Indications for Use: | The turbine handpiece is intended for the following
applications: Removal of decayed materials, cavities and
crown preparation, removal of fillings, finishing of tooth and
restoration surfaces.
The dental handpiece/contra-angle is intended for the
following applications: Removal of decayed materials,
cavities and crown cement, removal of fillings, finishing and
polishing of tooth and restoration surfaces. | | | | |
| Comparison of the device
to the predicate device | | Predicate
Device
K143704 | New Device | | |
| | Intended Use | Advanced Air
System:
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 restoration
surfaces, polishing,
prophylaxis and
endodontics. | Air-Powered
Handpieces:
The turbine
handpiece is
intended for the
following
applications:
Removal of
decayed materials,
cavities and crown
preparation,
removal of fillings,
finishing of tooth
and restoration
surfaces. | Similar* | |
| | Speed | RK-97 L: 400,000
RK-94 L: 410,000 | TK-94 L: 410.000
TK-98 L: 360,000
TK-100 L: 330,000
TE-97 LQ: 390,000 | Similar | |
| | Operating
pressure | RK-97 L: 3±0.3
RK-94 L: 3±0.3 | TK-94 L: 3±0.3
TK-98 L: 3±0.3
TK-100 L: 3±0.3
TE-97 LQ: 2.2 - 2.8 | Same | |
| | Current
consumption | RK-97 L: 0.4 A
RK-94 L: 0.4 A | TK-94 L: 0.4 A
TK-98 L: 0.4 A
TK-100 L: 0.4 A
TE-97 LQ: 0.4 A | Same | |
| | Air
consumption | RK-97 L: 45 Nl/min
RK-94 L: 75 Nl/min | TK-94 L: 45 NL/min
TK-98 L: 50 NL/min
TK-100 L: 50 NL/min
TE-97 LQ: 50
NL/min | Similar** | |
| | | *The Indications for Use of the Advanced Air System is a combination of the Indications
for Use of the Air-Powered Handpieces and the Air Motor and therefore similar.
**The new Air-Powered Handpieces are identical to the older versions; the main
difference is that the new ones cannot be sensor controlled. | | | |
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Image /page/6/Picture/0 description: The image shows a logo with the text "W&H" inside a gray hexagon. 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 people.
W&H Air-Powered Handpieces and Handpiece Attachments
| | Predicate Device
K070663 | New Device | | |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|------------|
| | A-dec/W&H Synea
Handpiece Attachment: | Handpiece
Attachment: | Same | |
| Intended Use | The straight and contra-
angle handpiece is
intended for the cutting a
tooth for cavity
preparation, crown
preparation, crown
finishing, inlay, filling and
polishing. | The dental
straight/contra-angle
handpiece is intended
for the following
applications: Removal of
decayed materials
cavities and crown
cement, removal of
fillings, finishing and
polishing of tooth and
restoration surfaces. | | |
| Speed (rpm) | WA-66 LT: 40,000
WA-99 LT: 40,000
HA-43 LT: 40,000 | WG-56 LT: 40,000
WK-99 LT: 40,000
HK-43 LT: 40,000 | Same | |
| Spray flow
rate | WA-66 LT: >50 ml/min
WA-99 LT: >50 ml/min
HA-43 LT: >50 ml/min | WG-56 LT: >50 ml/min
WK-99 LT: >50 ml/min
HK-43 LT: >50 ml/min | Same | |
| Chip air
setting range
(bar) | WA-66 LT: 1.5 - 3
WA-99 LT: 1.5 - 3
HA-43 LT: 1.5 - 3 | WG-56 LT: 1.5 - 3
WK-99 LT: 1.5 - 3
HK-43 LT: 1.5 - 3 | Same | |
| Water setting
range (bar) | WA-66 LT: 0.5 - 2
WA-99 LT: 0.5 - 2
HA-43 LT: 0.5 - 2 | WG-56 LT: 0.5 - 2
WK-99 LT: 0.5 - 2
HK-43 LT: 0.5 - 2 | Same | |
| Dental bur
shank
diameter | WA-66 LT: 2.35 mm
WA-99 LT: 1.6 mm
HA-43 LT: 2.35 mm | WG-56 LT: 2.35 mm
WK-99 LT: 1.6 mm
HK-43 LT: 2.35 mm | Same | |
| | Predicate Device
K143704 | New Device | | |
| | Air Motor
RM-25 L RM | Air Motor
AM-20 RM | | |
| Intended Use | The air motor is
intended for the
following applications:
Drive for dental
transmission instrument
for dental restoration,
prophylaxis and root
canal preparation.
Supply of dental
transmission
instruments with cooling
air, chip air, spray water
and light. | The air motor is
intended for the
following applications:
Drive for dental
transmission
instruments for dental
restoration and
prophylaxis. Supply of
dental transmission
instruments with cooling
air, chip air, spray water
and light. | Same | |
| | | | | |
| Operating
pressure | 1.5 – 2.5 bar | 2.2 – 3 bar | | Similar |
| Current
consumption | 0.7 A | N/A | | Different* |
| Air consumption | 42 – 51 Nl/min | 42 – 50 Nl/min | | Same |
| Length | 87,87 mm | 80 mm | | Similar |
| Diameter | 20 mm | 18 mm | | Similar** |
| | *no current consumption because the new models are not sensor controlled
**Smaller diameter to be compatible with new handpieces | | | |
| | | Hygiene / Maintenance – Air-Powered Handpieces and
Handpiece Attachments | | |
| Item | Predicate
devices
(K143704 and
K070663) | New device | Differences | |
| Lubrication | after max. 30
minutes of use | after max. 30
minutes of use | None | |
| Cleaning | rinse under
demineralized
water (