Dental Air Polishing Handpiece

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September 28, 2022 Guilin Woodpecker Medical Instrument Co., Ltd. % Charles Mack Principal Engineer IRC 2950 E Lindrick Drive Chandler, Arizona 85249 Re: K221548 Trade/Device Name: Dental Air Polishing Handpiece Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I, reserved Product Code: EFB Dated: August 31, 2022 Received: August 31, 2022 Dear Charles Mack: 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. {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 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 mediation-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 and ENT 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) K221548 Device Name Dental Air Polishing Handpiece #### Indications for Use (Describe) The Dental Air Polishing Handpiece, AP-H Plus is a dental handpiece intended for use in the cleaning and polishing of teeth by the projection of a mixture of water, air, and powder onto the tooth surface. The device removes soft deposits and areas of discoloration and can be used to prepare teeth for dental procedures such as the placement of composite fillings, porcelain inlays, and laminate veneers. The device can be used to clean implant abutments and to clean teeth prior to treatments such as shade matching, fluoridation, and bleaching. The device can also be used to degrease crowns and bridges prior to placement and clean fixed bands and brackets on orthodontic appliances. The Dental Air Polishing Handpiece, AP-H Plus is intended for patients suffering from periodontal disease. The Dental Air Polishing Handpiece, AP-H Plus is indicated for the non-surgical removal of subgingival plaque in pockets up to 4 mm after initial periodontal treatment. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------| | <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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The woodpecker icon is a simplified, abstract representation of the bird, with a long beak and a curved body. | K221548 | 510(k) SUMMARY | |----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Preparation Date: | September 27, 2022 | | Manufacturer's Name and Address: | Guilin Woodpecker Medical Instrument<br>Co., Ltd<br>Information Industrial Park, Guilin<br>National High-Tech Zone, Guilin City,<br>Guangxi Province, China 541004 | | Corresponding Official: | Charles Mack | | Telephone Number: | 931-625-4938 | | Email Address: | charliemack@irc-us.com | | Trade Name: | Dental Air Polishing Handpiece<br>AP-H Plus | | Common Name(s): | handpiece, air-powered, dental | | Requlation Name(s): | Dental handpiece and accessories. | | Regulation Number(s): | 21CFR872.4200 | | Product Code: | EFB | | Device Class: | Class II | | Predicate Device: | E.M.S. Electro Medical Systems S.A.<br>K151912 | {4}------------------------------------------------ # Device Description: The Dental Air Polishing Handpiece, AP-H Plus is an air driven dental handpiece for the use by a trained professional in the field of supragingival and the subgingival treatment. The devices are air-powered handpieces that are reusable. The proposed Dental Air Polishing Handpiece, AP-H Plus device is similar in design to the predicates AIR-FLOW handy 3.0 PLUS (K151912) . The proposed Dental Air Polishing Handpiece, AP-H Plus device and the predicates connect to a standard air turbine connection on a dental operative unit and deliver a mixture of water, air, and prophylaxis powder to a treatment site. The subject Dental Air Polishing Handpiece is comprised of a supragingival handpiece (model: AP - 1 Plus) a subgingival handpiece (model: AP - 2 Plus), spray head, nozzle, powder storage chamber, and tail cord connector. # Indications for Use The Dental Air Polishing Handpiece, AP-H Plus is a dental handpiece intended for use in the cleaning and polishing of teeth by the projection of a mixture of water, air, and powder onto the tooth surface. The device removes soft deposits and areas of discoloration and can be used to prepare teeth for dental procedures such as the placement of composite fillings, porcelain inlays, and laminate veneers. The device can be used to clean implant abutments and to clean teeth prior to treatments such as shade matching, fluoridation, and bleaching. The device can also be used to degrease crowns and bridges prior to placement and clean fixed bands and brackets on orthodontic appliances. The Dental Air Polishing Handpiece, AP-H Plus is intended for patients suffering from periodontal disease. The Dental Air Polishing Handpiece, AP-H Plus is indicated for the non-surgical removal of subgingival plaque in pockets up to 4 mm after initial periodontal treatment. {5}------------------------------------------------ # Comparison of Technological Characteristics with the Predicate Device | Characteristics | Subject Device | Predicate Device | Discussion | |--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device | Dental Air Polishing Handpiece, AP-H Plus | AIR-FLOW handy 3.0 PLUS | - | | 510K Applicant | Guilin Woodpecker Medical Instrument<br>Co., Ltd. | E.M.S. ELECTRO MEDICAL<br>SYSTEMS S.A. | - | | 510(K) Number | Pending | K151912 | - | | Regulation<br>Number | CFR872.4200 | CFR872.4200 | Identical | | Product Code | EFB | EFB | Identical | | Classification<br>Name | Air-powered dental handpiece | Air-powered dental handpiece | Identical | | OTC or<br>Prescription | Prescription Use | Prescription Use | Identical | | Medical Specialty | Dental | Dental | Identical | | Characteristics | Subject Device | Predicate Device | Discussion | | Indication for Use | The Dental Air Polishing Handpiece, AP-H Plus is a dental handpiece intended for use in the cleaning and polishing of teeth by the projection of a mixture of water, air, and powder onto the tooth surface. The device removes soft deposits and areas of discoloration and can be used to prepare teeth for dental procedures such as the placement of composite fillings, porcelain inlays, and laminate veneers. The device can be used to clean implant abutments and to clean teeth prior to treatments such as shade matching, fluoridation, and bleaching. The device can also be used to degrease crowns and bridges prior to placement and clean fixed bands and brackets on orthodontic appliances. | The AIR-FLOW handy 3.0 PLUS is a dental handpiece intended for use in the cleaning and polishing of teeth by the projection of a mixture of water, air, and EMS prophylaxis powder onto the tooth surface. The device removes soft deposits and areas of discoloration and can be used to prepare teeth for dental procedures such as the placement of composite fillings, porcelain inlays, and laminate veneers. The device can be used to clean implant abutments and to clean teeth prior to treatments such as shade matching, fluoridation, and bleaching. The device can also be used to degrease crowns and bridges prior to placement and clean fixed bands and brackets on orthodontic appliances. | Identical | | | The Dental Air Polishing Handpiece, AP-H Plus is intended for patients suffering from periodontal disease. | The AIR-FLOW handy 3.0 PLUS is intended for patients suffering from periodontal disease. | | | | The Dental Air Polishing Handpiece, AP-H Plus is indicated for the non-surgical removal of subgingival plaque in pockets up to 4 mm after initial periodontal treatment. | The AIR-FLOW handy 3.0 PLUS is indicated for the non-surgical removal of subgingival plaque in pockets up to 4 mm after initial periodontal treatment. | | | Characteristics | Subject Device | Predicate Device | Discussion | | Treatment Site | Supragingival and Subgingival | Supragingival and Subgingival | Identical | | Compatible<br>Prophylaxis<br>Powders | Glycine<br>Sodium bicarbonate<br>Erythritol | Glycine | The subject device including two<br>additional compatible prophylaxis<br>powders; They confirm to the<br>same performance requirement<br>as predicate device | | Function | Air-polishing | Air-polishing | Identical | | Mechanism of<br>Action | Projection of water/air/powder mixture | Projection of water/air/powder<br>mixture | Identical | | Operation Mode | Continuous operation | Continuous operation | Identical | | Service Pressure<br>to the Turbine<br>Connection | Water:<br>1 to 2.2 bar (1000-2200 hPa)<br>Air:<br>Static pressure 2.7 to 3.5 bar (2700-<br>3500 hPa) | Water:<br>1 to 2.2 bar (1000-2200 hPa)<br>Air:<br>Static pressure 2.7 to 3.5 bar<br>(2700-3500 hPa) | Identical | | Operating<br>Conditions | +10°C to +40°C, 30% to 75% relative<br>humidity,<br>700 hPa to 1060 hPa air pressure, | +10°C to +40°C, 30% to 75%<br>relative humidity,<br>700 hPa to 1060 hPa air<br>pressure, | Identical | | Usage | Re-useable | Re-useable | Identical | | Weight | Approx. 0.125kg | Approx. 0.150kg | Similar | | How Supplied | Non-sterile; Subject to be sterilized<br>before each use | Non-sterile; Subject to be<br>sterilized before each use | Identical | | Applicable<br>Sterilization | Moist heat - Autoclave sterilization | Moist heat - Autoclave<br>sterilization | Identical | | Performance | ANSI/AAMI ST79<br>ANSI/AAMI/ISO 17665-1<br>IEC 62366<br>ISO 15223-1<br>ISO 17664 | ANSI/AAMI ST79<br>ANSI/AAMI/ISO 17665-1<br>IEC 62366<br>ISO 15223-1<br>ISO 17664 | Identical | | Biocompatibility | Complies with ISO 10993-1 | Complies with ISO 10993-1 | Identical | {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ ### Performance Testing Performance testing was provided in support of the substantial equivalence determination and to validate and verify that the Dental Air Polishing Handpiece, AP-H Plus met all requirements of related international standards. The results of these tests demonstrate compliance with the requirements of the consensus standards noted below. # Non-clinical Testing #### Performance Testing - ISO 20608 First edition 2018-04 Dentistry Powder jet handpieces and powders - ISO 9168 Dentistry Hose connectors for air driven dental handpieces i ## Biocompatibility Information The subject device is classified as surface device and contact mucosal membrane for limited contact (duration ≤ 24 h). The following tests were performed to ensure compliance with biocompatibility requirements. - । ISO10993-1: BIOLOGICAL EVALUATION OF MEDICAL DEVICES - ISO10993-5 Cytotoxicity Tests - - ISO10993-10 Skin Irritation test - - ISO10993-10 Oral Mucosa Irritation test - - ISO10993-10 Sensitization Test - # Sterility Information The handpiece is supplied non-sterile and subject to be sterilized by autoclave prior to use. Fractional pre-vacuum cycle at 132°C for 4 min and a drying time of 20 min same as predicate device. Recommended sterilization method which has been validated as below: Sterilization validation for the handpieces was performed in accordance with the standards noted below: - ANSI AAMI ST79:2017, Comprehensive quide to steam sterilization and । sterility assurance in health care facilities - । 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 (Sterility) The cleaning method has been validated for the handpiece and the powder chamber per AAMI TIR30 and the FDA Guidance Reprocessing Medical Devices in Health {9}------------------------------------------------ Care Settings: Validation Methods and Labeling. The intermediate-level disinfection method has been validation for the powder chamber and cord per AAMI TIR12: {10}------------------------------------------------ ## Clinical Test: No clinical study is included in this submission. ### Shelf Life: The device is not delivered sterile and low likelihood of time-dependent product degradation, therefore, the shelf-life is not applicable. #### Conclusions: The differences between the predicate and the subject device do not raise any new or different questions of substantial equivalence. The Dental Air Polishing Handpiece, AP-H Plus is substantially equivalent to the E.M.S. Electro Medical Systems S.A., Inc. AIR-FLOW handy 3.0 PLUS cleared under K151912 with respect to the indications for use, target populations, treatment method, and technological characteristics. -END-