Who is the manufacturer of Air-Powered Handpieces and Handpiece Attachments?

W&H Dentalwerk Burmoos GmbH filed the 510(k) submission for Air-Powered Handpieces and Handpiece Attachments (K162926).

What is the FDA product code for Air-Powered Handpieces and Handpiece Attachments?

EFB. It is classified under 21 CFR 872.4200 as a Class 1 device in the Dental panel.

What is the regulatory pathway for Air-Powered Handpieces and Handpiece Attachments?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Air-Powered Handpieces and Handpiece Attachments?

Advanced Air System (K143704); A-dec/W&H Synea Air-Driven Highspeed Handpiece (K070663); A-dec/W&H Synea Handpiece Attachment (K070663).

Who can help prepare an FDA 510(k) submission like Air-Powered Handpieces and Handpiece Attachments?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Air-Powered Handpieces and Handpiece Attachments

K162926 · W&H Dentalwerk Burmoos GmbH · EFB · Feb 23, 2017 · Dental

Device Facts

Record ID	K162926
Device Name	Air-Powered Handpieces and Handpiece Attachments
Applicant	W&H Dentalwerk Burmoos GmbH
Product Code	EFB · Dental
Decision Date	Feb 23, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.4200
Device Class	Class 1
Attributes	Therapeutic

Intended 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.

Device Story

Air-powered dental handpieces and attachments; used for tooth preparation, filling removal, and finishing/polishing. Device utilizes air-driven turbines or air motors to rotate burs; air and water pipes supply spray for cooling the working area and bur. Some models include integrated LED light systems powered by internal circuit boards. Operated by dental professionals in clinical settings. Output is mechanical rotation of dental burs for tissue/restoration removal. Benefits include efficient dental material removal and surface finishing. Device is reusable; requires cleaning and sterilization between patients.

Clinical Evidence

Bench testing only. Performance testing conducted per ISO 14457:2012 (function and life cycle), IEC 60601-1-2:2007 (EMC), and IEC 62471:2006 (photobiological safety). Biocompatibility evaluated via comparison to predicate materials and Cytotoxicity Testing per EN ISO 10993-5:2009, meeting ISO 7405:2008 requirements. No clinical data required.

Technological Characteristics

Reusable air-powered handpieces and attachments. Materials identical to predicates. Features include air-driven turbines/motors, air/water spray cooling, and optional LED illumination. Connectivity: pneumatic supply. Sterilization: dynamic-air-removal or gravity displacement autoclaves (132°C). Complies with ISO 14457, IEC 60601-1-2, IEC 62471, and ISO 10993-5.

Indications for Use

Indicated for dental patients requiring removal of decayed materials, cavity and crown preparation, removal of fillings, and finishing/polishing of tooth and restoration surfaces.

Regulatory Classification

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.

Predicate Devices

Advanced Air System (K143704)
A-dec/W&H Synea Air-Driven Highspeed Handpiece (K070663)
A-dec/W&H Synea Handpiece Attachment (K070663)

Related Devices

K093971 — DENTAL HANDPIECE · North West Medical Instrument (Group) Co., Ltd. · Apr 22, 2010
K082716 — A-DEC/W&H ALEGRA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TE-97, TE-98, A-DEC/W&H ALEGRA HANDPIECE ATTACHMENT, MODEL HE-43 · A-Dec, Inc. · Jan 15, 2009
K113222 — ND LOWSPEED AIRMOTOR,ND HIGHSPEED AIRTURBINE HANDPIECE · Nakamura Dental Handpiece Mfg. Co., Ltd. · Feb 23, 2012
K150798 — Codent Low Speed Dental Handpieces and Accessories · Codent Technical Industry Co., Ltd. · Apr 24, 2015
K220179 — High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors · Foshan Coxo Medical Instrument Co., Ltd. · Sep 22, 2023

Submission Summary (Full Text)

{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 {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows a logo with the letters "W&H" inside a gray, rounded hexagon. Above the logo is a green banner with the text "PEOPLE HAVE PRIORITY" in white letters. The background is white, providing a clean and simple design. ## Indications for Use 510(k) number: K162926 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) {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows a logo with the letters "W&H" inside a gray hexagon. Above the logo, there is a green banner with the text "PEOPLE HAVE PRIORITY" written in white. The logo is simple and modern, with a focus on the company's initials and a statement about its values. # 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. | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows a logo with the letters "W&H" inside a gray, rounded hexagon. Above the logo, there is a green banner with the text "PEOPLE HAVE PRIORITY" in white letters. The background is white. # 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. | | | | {6}------------------------------------------------ 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 (< 38°C/100°F) with aid of brush | rinse under demineralized water (< 38°C/100°F) with aid of brush | None | | | Sterilization | Dynamic-air- removal sterilizers: 270°F (132°C) for 4 minutes or Gravity displacement sterilizers: 270°F (132°C) for 15 minutes | Dynamic-air- removal sterilizers: 270°F (132°C) for 4 minutes or Gravity displacement sterilizers: 270°F (132°C) for 15 minutes | None | | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows a logo with the letters "W&H" inside a gray, rounded hexagon. Above the logo, there is a green banner with the text "PEOPLE HAVE PRIORITY" in white letters. The background is a light gray color. # W&H Air-Powered Handpieces and Handpiece Attachments 510(k) Summary {8}------------------------------------------------ | Image: W&H logo | W&H Air-Powered Handpieces and Handpiece Attachments 510(k) Summary | | Section 5 Page 6 of 6 | |-----------------|---------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------| | | Performance Testing | 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 Testing | Clinical data were not needed for this new product. | | | | Conclusion | W&H considers the Air-Powered Dental Handpieces and Handpiece Attachments to be substantially equivalent to the predicate devices listed above. This conclusion is based on the similarities in intended use, principles of operation, material composition, 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. | |