(84 days)
Not Found
No
The device description and performance studies focus on mechanical action (spraying powder and water with compressed air) for cleaning. There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
Yes.
The device is intended for the removal of soft deposits from teeth and prostheses, specifically for non-surgical removal of subgingival plaque, which falls under the definition of a therapeutic purpose for treating oral conditions.
No
The device is described as an "Air Powered Tooth Polishing System" used for the "Removal of supragival/subgingival soft deposits and soft deposits on prostheses". Its function is to perform a physical action (polishing/cleaning) rather than to diagnose a condition or disease.
No
The device description explicitly details hardware components (handpiece, nozzle tip) and their physical function (spraying powder and water with compressed air). It also mentions cleaning and sterilization, which are hardware-related processes.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Perio-Mate and Perio Mate Nozzle Tip are used to physically remove soft deposits from teeth and prostheses using a mixture of polishing powder, water, and compressed air. This is a mechanical cleaning process performed directly on the patient's oral cavity.
- Lack of Specimen Analysis: The device does not analyze any biological specimens taken from the patient. It operates externally on the tooth surface and within the periodontal pocket.
The intended use and device description clearly indicate a dental device for cleaning and removing deposits, not for analyzing biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
Perio-Mate:
Perio-Mate is intended for the following application(s):
Removal of supragival/subgingival soft deposits and soft deposits on prostheses (including implant abutments).
Perio Mate Nozzle Tip:
Perio Mate Nozzle Tip is intended for the following application(s):
Removal of subgingival soft deposits and soft deposits on prostheses (including implant abutments).
The Perio Mate Nozzle Tip and Perio-Mate is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment.
Product codes
EFB
Device Description
Perio-Mate:
This device is used to remove stains and deposits by spraying the polishing powder and water mixed by compressed air when connected with chair units through couplings and hoses to the treatment area. This device consists of a handpiece and a powder case. Couplings connected with powder case of this device have different structures, This device is developed, considering the connection with each manufacture's type. Some of them have the direct connection with hose that is with accordance with ISO 9186. This device is delivered in a non-sterile state and sterilized by end-users as a reusable device. This device to be used for sub and supraginal purpose. During subgingival treatment, Perio Mate Nozzle Tip is of the handpiece.
Perio Mate Nozzle Tip:
This device is connected to the Perio-Mate handpiece. The compressed air makes the tooth polishing agent in the Perio-Mate mixed and transfers it to the tip. The product is inseriodontal pocket, sprays the tooth polishing agent/water to the treatment area in the subgingival area, and enables to remove the deposits from teeth surface or prostheses. The product is EOG sterile single-use device.
The Air Powered Tooth Polishing System includes the Perio-Mate, which consists of a handpiece and the Perio Mate Nozzle Tip, which is connected to the end of the Perio-Mate handpiece.
Perio-Mate is used to remove stains and deposits by spraying the polishing powder and water mixed by compressed air when connected with chair units through couplings or hoses to the treatment area. This device is a non-sterile state and intended to be cleaned and sterilized by end-users as a reusable device. This device to be used for supragingival purpose.
During subgingival treatment, Perio Mate Nozzle Tip is connected to the handpiece. The compressed air makes the tooth polishing agent in the Perio-Mate mixed and transfers it to the tip. The product is inserted in a periodontal pocket, sprays the tooth polishing agent/water to the treatment area in the subgingival area, and enables to remove the deposits from teeth surface or prostheses.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Teeth, periodontal pocket
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)
Non-Clinical Tests:
The Air Powered Tooth Polishing System subjected to verification and validation testing for product performance and reprocessing to support substantial equivalence. The rests demonstrate compliance with the requirements of the following standards and guidance:
• ISO 20608:2018 "Dentistry - Powder jet handpieces and powders"
• 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"
• ISO 17664-1:2021 "Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices"
• ISO 17664-2:2021 "Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices."
• FDA guidance document "Dental Handpieces - Premarket Notification [510(k)] Submissions"
• FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling"
Biocompatibility Test:
Biocompatibility testing was conducted. The test results demonstrate compliance with the requirements of the following standards and guidance:
- ISO 10993-1:2018 "Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process"
- FDA guidance document "Biological evaluation of medical devices Part 1: Evaluation and testing within a risk process"
The Non-Clinical Tests result support the substantial equivalence of the subject Air Polishing System to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
September 20, 2024
Nakanishi Inc. Ikeda Satoru Regulatory Affairs Dept. Tix Tower Ueno 9F 4-8-1, Higashiueno Taito-ku, Tokyo 110-0015 Japan
Re: K241880
Trade/Device Name: Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip) Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I, reserved Product Code: EFB Dated: June 28, 2024 Received: June 28, 2024
Dear Ikeda Satoru:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
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Sincerely,
Bobak Shirmohammadi -S
For Michael E. Adjodha, MChE, RAC, CQIA 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
3
Indications for Use
Submission Number (if known)
Device Name
Air Powered Tooth Polishing System (Perio-Mate);
Air Powered Tooth Polishing System (Perio Mate Nozzle Tip)
Indications for Use (Describe)
Perio-Mate:
Perio-Mate is intended for the following application(s):
Removal of supragingival soft deposits and soft deposits on prostheses (including implant abutments).
Perio Mate Nozzle Tip:
Perio Mate Nozzle Tip is intended for the following application(s):
Removal of subgingival soft deposits and soft deposits on prostheses (including implant abutments).
The Perio Mate Nozzle Tip and Perio-Mate is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) #: K241880
510(k) Summary
Prepared on: 2024-09-18
Contact Details
21 CER 807.92(a)(1)
| Applicant Name | NAKANISHI INC. | 21 CFR 807.92(a)(1) |
|---|---|---|
| Applicant Address | 700 Shimohinata Kanuma Tochigi 322-8666 Japan | |
| Applicant Contact Telephone | +81-289-64-7277 | |
| Applicant Contact | Mr. Kikuchi Masaaki | |
| Applicant Contact Email | m-kikuchi@nsk-nakanishi.co.jp | |
| Correspondent Name | NAKANISHI INC. | |
| Correspondent Address | TIX TOWER UENO 9F 4-8-1, Higashiueno Taito-ku Tokyo 110-0015 Japan | |
| Correspondent Contact Telephone | +81-358-28-8590 | |
| Correspondent Contact | Mr. Ikeda Satoru | |
| Correspondent Contact Email | nskra-contact@nsk-nakanishi.co.jp | |
| Device Name | 21 CFR 807.92(a)(2) | |
| Device Trade Name | Air Powered Tooth Polishing System (Perio-Mate); | |
| Air Powered Tooth Polishing System (Perio Mate Nozzle Tip) | ||
| Common Name | Dental handpiece and accessories | |
| Classification Name | Handpiece, Air-Powered, Dental | |
| Regulation Number | 872.4200 | |
| Product Code(s) | EFB | |
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K151912 | AIR-FLOW handy 3.0 PLUS | EFB |
| K171174 | PERIO-FLOW nozzle | EFB |
Perio-Mate
This device is used to remove stains and deposits by spraying the polishing powder and water mixed by compressed air when connected with chair units through couplings and hoses to the treatment area. This device consists of a handpiece and a powder case. Couplings connected with powder case of this device have different structures, This device is developed, considering the connection with each manufacture's type. Some of them have the direct connection with hose that is with accordance with ISO 9186. This device is delivered in a non-sterile state and sterilized by end-users as a reusable device. This device to be used for sub and supraginal purpose. During subgingival treatment, Perio Mate Nozzle Tip is of
5
the handpiece.
Perio Mate Nozzle Tip
This device is connected to the Perio-Mate handpiece. The compressed air makes the tooth polishing agent in the Perio-Mate mixed and transfers it to the tip. The product is inseriodontal pocket, sprays the tooth polishing agent/water to the treatment area in the subgingival area, and enables to remove the deposits from teeth surface or prostheses. The product is EOG sterile single-use device.
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
Perio-Mate:
Perio-Mate is intended for the following application(s):
Removal of supragival/subgingival soft deposits and soft deposits on prostheses (including implant abutments).
Perio Mate Nozzle Tip:
Perio Mate Nozzle Tip is intended for the following application(s):
Removal of subgingival soft deposits and soft deposits on prostheses (including implant abutments).
The Perio Mate Nozzle Tip and Perio-Mate is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment.
Indications for Use Comparison
Both the Indications for Use for the subject device and the Indications for Use for the predicate device are intended for dental applications, including the removal of supragingival soft deposits on prostheses (including implant abutments).
The subject, predicate and reference device are indical for the non-surgical removal of subgingival plague in pockets up to 5 mm. The only difference between the Indictments for Use is the Device Name and product description.
Technological Comparison
21 CFR 807.92(a)(6)
21 CFR 807.92(a)(5)
The Air Powered Tooth Polishing System includes the Perio-Mate, which consists of a handpiece and the Perio Mate Nozzle Tip, which is connected to the end of the Perio-Mate handpiece.
Perio-Mate is used to remove stains and deposits by spraying the polishing powder and water mixed by compressed air when connected with chair units through couplings or hoses to the treatment area. This device is a non-sterile state and intended to be cleaned and sterilized by end-users as a reusable device. This device to be used for supragingival purpose.
During subgingival treatment, Perio Mate Nozzle Tip is connected to the handpiece. The compressed air makes the tooth polishing agent in the Perio-Mate mixed and transfers it to the tip. The product is inserted in a periodontal pocket, sprays the tooth polishing agent/water to the treatment area in the subgingival area, and enables to remove the deposits from teeth surface or prostheses.
The subject device shares these technical characteristics with the predicate device. These differences are only minor, such as the Perio Mate Nozzle Tip being an EOG sterilized disposable device, and dimensions. The Perio Mate Nozzle Tip being EOG sterilized, disposable, features that are not present in the predicate device but are present in the references reflect user preferences and market strategies and do not affect the substantial equivalence of the subject device.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CER 807.92(b)
Non-Clinical Tests
For Air Powered Tooth Polishing System, the following non-clinical tests were performed to support substantial equivalence of the subject device.
Performance Test:
The Air Powered Tooth Polishing System subjected to verification and validation testing for product performance and reprocessing to support substantial equivalence. The rests demonstrate compliance with the requirements of the following standards and guidance.
· ISO 20608:2018 "Dentistry - Powder jet handpieces and powders"
• 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"
· ISO 17664-1:2021 "Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices"
· ISO 17664-2:2021 "Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices."
6
· FDA guidance document "Dental Handpieces - Premarket Notification [510(k)] Submissions"
· FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" Biocompatibility Test:
Based on its Indications for Use, the Air Powered Tooth Polishing System, is classified as a device that has limited contact (less than 24 hours) with surface medical devices and breached or compromised surfaces.
To support substantial equivalence, biocompatibility testing was conducted. The test results demonstrate compliance with the requirements of the following standards and guidance:
- · ISO 10993-1:2018 "Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process"
- · FDA guidance document "Biological evaluation of medical devices Part 1: Evaluation and testing within a risk process"
The Non-Clinical Tests result support the substantial equivalence of the subject Air Polishing System to the predicate device.