(127 days)
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.
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.
The provided text is a 510(k) summary for W&H Air-Powered Handpieces and Handpiece Attachments, indicating their substantial equivalence to predicate devices. It describes the device, its intended use, and comparisons to predicate devices based on technical characteristics and performance testing. However, this document does not contain information regarding the acceptance criteria for an AI/ML medical device, nor does it detail a study proving such a device meets acceptance criteria.
The document explicitly states: "Clinical data were not needed for this new product." This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel performance through clinical studies or specific acceptance criteria for AI/ML algorithms.
Therefore, I cannot fulfill the request as it pertains to AI/ML device acceptance criteria and study details based on the provided text. The document describes a traditional medical device (dental handpieces) and its clearance process, not an AI/ML device.
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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
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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 GMBHIgnaz-Glaser-Strasse 53A - 5111 BürmoosAustriaTel.: 0043 -6274 / 6236 -397Fax: 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 underK070663The predicates have not been subject to a design-relatedrecall. |
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W&H Air-Powered Handpieces and
Handpiece Attachments 510(k) Summary
| 510(k) Summary | |
|---|---|
| DeviceDescriptionandTechnologicalCharacteristics | The Air-Powered Handpieces and the HandpieceAttachments are reusable, ergonomically shaped andsome of them include LED light system. |
| The submission is comprised of: | |
| • The W&H Synea Vision/Fusion Air-PoweredHandpieces: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-98RM | |
| • 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 HandpieceAttachments: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 HandpieceAttachments: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-66LED G, WE-99 LED G | |
| The Air-powered Handpieces contain pipes inside whichsupply air for driving the turbine's impeller as well assupply air and water for creating spray exhaustingthrough 3, 4 or 5 ports located in the handpiece's headand intended for cooling the working area as well as therotating bur. Depending on the type of handpiece – thehandle might contain an integrated circuit board and wirebundles, for supplying current and voltage to a head-sided assembled LED light source.The Handpiece Attachments also contain pipes insidewhich supply air and water for spray exhausting and forcooling the working area as well as the rotating bur.Depending on the type of handpiece – the handle mightcontain an integrated circuit board and wire bundles, for |
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| PEOPLE HAVE PRIORITY | ||
|---|---|---|
| 1 |
W&H Air-Powered Handpieces and Handpiece Attachments 510(k) Summary
| supplying current and voltage to a head-sided assembledLED light source. | |||||
|---|---|---|---|---|---|
| Indications for Use: | The turbine handpiece is intended for the followingapplications: Removal of decayed materials, cavities andcrown preparation, removal of fillings, finishing of tooth andrestoration surfaces.The dental handpiece/contra-angle is intended for thefollowing applications: Removal of decayed materials,cavities and crown cement, removal of fillings, finishing andpolishing of tooth and restoration surfaces. | ||||
| Comparison of the deviceto the predicate device | PredicateDeviceK143704 | New Device | |||
| Intended Use | Advanced AirSystem:Pneumatic drivesystem for dentalhandpieces anddental air motors,which is intended tobe used in generaldental applicationssuch as: removal ofdecayed materials,cavities and crownpreparations,removal of filings,finishing of toothand restorationsurfaces, polishing,prophylaxis andendodontics. | Air-PoweredHandpieces:The turbinehandpiece isintended for thefollowingapplications:Removal ofdecayed materials,cavities and crownpreparation,removal of fillings,finishing of toothand restorationsurfaces. | Similar* | ||
| Speed | RK-97 L: 400,000RK-94 L: 410,000 | TK-94 L: 410.000TK-98 L: 360,000TK-100 L: 330,000TE-97 LQ: 390,000 | Similar | ||
| Operatingpressure | RK-97 L: 3±0.3RK-94 L: 3±0.3 | TK-94 L: 3±0.3TK-98 L: 3±0.3TK-100 L: 3±0.3TE-97 LQ: 2.2 - 2.8 | Same | ||
| Currentconsumption | RK-97 L: 0.4 ARK-94 L: 0.4 A | TK-94 L: 0.4 ATK-98 L: 0.4 ATK-100 L: 0.4 ATE-97 LQ: 0.4 A | Same | ||
| Airconsumption | RK-97 L: 45 Nl/minRK-94 L: 75 Nl/min | TK-94 L: 45 NL/minTK-98 L: 50 NL/minTK-100 L: 50 NL/minTE-97 LQ: 50NL/min | Similar** | ||
| *The Indications for Use of the Advanced Air System is a combination of the Indicationsfor 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 maindifference is that the new ones cannot be sensor controlled. |
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W&H Air-Powered Handpieces and Handpiece Attachments
| Predicate DeviceK070663 | New Device | |||
|---|---|---|---|---|
| A-dec/W&H SyneaHandpiece Attachment: | HandpieceAttachment: | Same | ||
| Intended Use | The straight and contra-angle handpiece isintended for the cutting atooth for cavitypreparation, crownpreparation, crownfinishing, inlay, filling andpolishing. | The dentalstraight/contra-anglehandpiece is intendedfor the followingapplications: Removal ofdecayed materialscavities and crowncement, removal offillings, finishing andpolishing of tooth andrestoration surfaces. | ||
| Speed (rpm) | WA-66 LT: 40,000WA-99 LT: 40,000HA-43 LT: 40,000 | WG-56 LT: 40,000WK-99 LT: 40,000HK-43 LT: 40,000 | Same | |
| Spray flowrate | WA-66 LT: >50 ml/minWA-99 LT: >50 ml/minHA-43 LT: >50 ml/min | WG-56 LT: >50 ml/minWK-99 LT: >50 ml/minHK-43 LT: >50 ml/min | Same | |
| Chip airsetting range(bar) | WA-66 LT: 1.5 - 3WA-99 LT: 1.5 - 3HA-43 LT: 1.5 - 3 | WG-56 LT: 1.5 - 3WK-99 LT: 1.5 - 3HK-43 LT: 1.5 - 3 | Same | |
| Water settingrange (bar) | WA-66 LT: 0.5 - 2WA-99 LT: 0.5 - 2HA-43 LT: 0.5 - 2 | WG-56 LT: 0.5 - 2WK-99 LT: 0.5 - 2HK-43 LT: 0.5 - 2 | Same | |
| Dental burshankdiameter | WA-66 LT: 2.35 mmWA-99 LT: 1.6 mmHA-43 LT: 2.35 mm | WG-56 LT: 2.35 mmWK-99 LT: 1.6 mmHK-43 LT: 2.35 mm | Same | |
| Predicate DeviceK143704 | New Device | |||
| Air MotorRM-25 L RM | Air MotorAM-20 RM | |||
| Intended Use | The air motor isintended for thefollowing applications:Drive for dentaltransmission instrumentfor dental restoration,prophylaxis and rootcanal preparation.Supply of dentaltransmissioninstruments with coolingair, chip air, spray waterand light. | The air motor isintended for thefollowing applications:Drive for dentaltransmissioninstruments for dentalrestoration andprophylaxis. Supply ofdental transmissioninstruments with coolingair, chip air, spray waterand light. | Same | |
| Operatingpressure | 1.5 – 2.5 bar | 2.2 – 3 bar | Similar | |
| Currentconsumption | 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 andHandpiece Attachments | ||||
| Item | Predicatedevices(K143704 andK070663) | New device | Differences | |
| Lubrication | after max. 30minutes of use | after max. 30minutes of use | None | |
| Cleaning | rinse underdemineralizedwater (<38°C/100°F) withaid of brush | rinse underdemineralizedwater(< 38°C/100°F)with aid of brush | None | |
| Sterilization | Dynamic-air-removalsterilizers: 270°F(132°C) for 4minutes orGravitydisplacementsterilizers:270°F (132°C) for15 minutes | Dynamic-air-removal sterilizers:270°F (132°C) for4 minutes orGravitydisplacementsterilizers:270°F (132°C) for15 minutes | None |
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W&H Air-Powered Handpieces and Handpiece Attachments
510(k) Summary
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| Image: W&H logo | W&H Air-Powered Handpieces andHandpiece Attachments510(k) Summary | Section 5Page 6 of 6 | |
|---|---|---|---|
| Performance Testing | Product testing of the handpieces function and life cycletesting were performed according to ISO 14457:2012:Dentistry – Handpieces and Motors. The resultsdemonstrate substantial equivalence in this regard.EMC Testing according to IEC 60601-1-2:2007 Medicalelectrical equipment Part 1-2 General requirements...Electromagnetic CompatibilityThermal safety according to the standard IEC 62471:2006:Photobiological safety of lamps and lamp systemsEvaluation of biocompatibility is based upon the fact thatpatient contacting materials in the subject handpiece areidentical to those in the previously cleared predicates(K143704 and K070663), which as handpieces andhandpiece attachments, present the same level andduration of contact. In addition, Cytotoxicity Testing per ENISO 10993-5:2009 was performed. This evaluation meetsthe requirements of ISO 7405:2008 for preclinicalevaluation of biocompatibility of dental devices.Various functionality and lifecycle tests as well as furtherbench tests demonstrate substantial equivalence. | ||
| Clinical Testing | Clinical data were not needed for this new product. | ||
| Conclusion | W&H considers the Air-Powered Dental Handpieces andHandpiece Attachments to be substantially equivalent to thepredicate devices listed above. This conclusion is based onthe similarities in intended use, principles of operation,material composition, functional design and establishedmedical use. Differences between the devices shown in theside-by-side comparison table above are minor and do nothave any negative effect on equivalence. |
§ 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.