PANA SPRAY Plus

K163483 · Nakanishi, Inc. · EFB · Aug 15, 2017 · Dental

Device Facts

• Record ID: K163483
• Device Name: PANA SPRAY Plus
• Applicant: Nakanishi, Inc.
• Product Code: EFB · Dental
• Decision Date: Aug 15, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1

Intended Use

PANA SPRAY Plus is a lubricant to be used during routine maintenance of dental and medical surgical handpieces after each patient use and prior to sterilization and is intended for use to clean and lubricate the dental surgical handpieces.

Device Story

PANA SPRAY Plus is an alcohol-based aerosol lubricant; used for routine maintenance of high-speed/low-speed dental and medical surgical handpieces and air motors. Applied after each patient use and prior to sterilization; introduced into handpiece via air-drive pipe or back end. Cleans and lubricates internal components to ensure device reliability and durability. Used in dental clinics by dental staff. Benefits include maintenance of handpiece performance, bur extraction force, eccentricity, noise levels, and stopping torque.

Clinical Evidence

Bench testing only. Reprocessing/cleaning validation performed per FDA guidance. Biocompatibility testing conducted per ANSI/AAMI/ISO 10993-1 (cytotoxicity, sensitization, irritation). Reliability and durability testing included package vibration, unit drop, temperature testing, and repeated usage. Performance equivalence demonstrated against predicate K113674 for bur extraction force, eccentricity, noise level, and stopping torque per ISO 14557.

Technological Characteristics

Aerosol-based lubricant and cleaner. Proprietary alcohol-based formulation. Delivered via aerosol can. Compatible with high/low speed handpieces and air motors. Tested for reliability and durability per internal standards. Biocompatibility per ISO 10993-1.

Indications for Use

Indicated for cleaning and lubrication of dental and medical surgical handpieces after each patient use and prior to sterilization.

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

• PANA SPRAY Plus (K131014)

Reference Devices

• Spray & Clean/Maxima/EZcare Handpiece Cleaner & Lubricant (K113674)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 15,2017

Nakanishi, Inc. % Diane Rutherford Submissions Manger Ken Block Consulting 1201 Richardson Drive, Suite 160 Richardson. Texas 75080

Re: K163483

Trade/Device Name: Pana Spray Plus Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I Product Code: EFB Dated: July 31, 2017 Received: August 3, 2017

Dear Diane Rutherford:

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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Mary S. Runner -S

for

Lori A. Wiggins, MPT, CLT 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known)

K163483

Device Name PANA SPRAY Plus

Indications for Use (Describe)

PANA SPRAY Plus is a lubricant to be used during routine maintenance of dental and medical surgical handpieces after each patient use and prior to sterilization and is intended for use to clean and lubricate the dental surgical handpieces.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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## 510(k) SUMMARY

| Submitter: | NAKANISHI, INC.<br>700 Shimohinata<br>Kanuma-shi, Tochigi-ken 322-8666 Japan | | | | New Device | Primary Predicate Devices | | |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|------------------------------|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact Person: | NAKANISHI, INC.<br>Mr. Kimihiko Satoh<br>General Manager, Regulatory Affairs Dept<br>TEL: [phone]<br>FAX: [phone]<br>[e-mail] | | | Trade Name | PANA SPRAY Plus | PANA SPRAY Plus | Spray & Clean Handpiece<br>Cleaner & Lubricant | |
| Date Prepared: | August 11, 2017 | | | Description | | | | |
| Trade Name: | PANA SPRAY Plus | | | 510(k) Submitter<br>[Number] | NAKANISHI, INC.<br>[K163483] | NSK America<br>(A subsidiary of NAKANISHI, INC.)<br>[K131014] | HANDPIECE<br>HEADQUARTERS<br>[K113674] | |
| Common Name: | Dental handpieces and accessories | | | Product Code(s)<br>Regulation | EFB<br>872.4200 | EFB<br>872.4200 | EFB<br>872.4200 | |
| Classification<br>Name: | Handpiece, air-powered, dental | | | Class | 1 | 1 | 1 | |
| Product Code: | EFB Class 1 872.4200 | | | Prescription Only ? | Yes | Yes | Yes | |
| Predicate<br>Devices: | PRIMARY: K131014 - NAKANISHI, INC. PANA SPRAY Plus<br>REFERENCE: K113674 - Handpiece Headquarters Inc, - HPR Inc.<br>Spray & Clean/Maxima/EZcare Handpiece Cleaner & Lubricant | | | Indication for Use | PANA SPRAY Plus is a<br>lubricant to be used during<br>routine maintenance of<br>dental and medical<br>surgical handpieces after<br>each patient use and prior<br>to sterilization and is<br>intended for use to clean<br>and lubricate the dental<br>and medical surgical<br>handpieces. | PANA SPRAY Plus is a<br>lubricant intended to be<br>used during routine<br>maintenance of dental and<br>medical surgical<br>handpieces after each<br>patient use and prior to<br>sterilization. | The Dental Handpiece<br>Cleaner and Lubricant is<br>intended to be used<br>during routine<br>maintenance in order to<br>lubricate and clean air-<br>powered Dental<br>Handpieces (including<br>low speed and high<br>speed) and Dental air<br>motors after each patient<br>use and prior to<br>sterilization.<br>The Dental Handpiece<br>Lubricant is intended to<br>be used during routine<br>maintenance in order to<br>lubricate air-powered<br>Dental Handpieces<br>(including low speed and<br>high speed) and Dental<br>air motors after each<br>patient use and prior to<br>sterilization. | |
| Device<br>Description: | PANA SPRAY Plus (PSP) is an alcohol-based general handpiece and air-motor<br>lubricant. The lubricant is introduced into the handpiece through the air-drive<br>pipe or the back end. PANA SPRAY Plus can be used for the maintenance of<br>high speed handpieces, low speed handpieces, and air motors and should be<br>used after each patient and prior to sterilization of handpiece and air motors.<br>Additional testing has been conducted to support the claim for cleaning. | | | Device Design | | | | |
| Indications<br>for Use: | PANA SPRAY Plus is a lubricant to be used during routine maintenance of<br>dental and medical surgical handpieces after each patient use and prior to<br>sterilization and is intended for use to clean and lubricate the dental and<br>medical surgical handpieces. | | | Availability: | 480 mL Can<br>Case of 6 (480 mL) Cans | 480 mL Can<br>Case of 6 (480 mL) Cans | 6 oz Can<br>Case of 12 cans | |
| Summary of<br>Technological<br>Characteristics: | The reason for this submission is to change the previously cleared Pana Spray<br>Plus indications (K131014) to include cleaning. The proposed PSP and the<br>predicate Spray & Clean Handpiece Cleaner & Lubricant (K113674) both are<br>indicated for cleaning and lubrication of handpieces (including low speed and<br>high speed) and air motors after each patient use and prior to sterilization.<br><br>The proprietary formulation of the proposed PANA SPRAY Plus (PSP) is<br>unchanged from that of the predicate Pana Spray Plus (K131014). The<br>proprietary formulation of PSP and both predicates includes lubricant and<br>alcohol components. All are for prescription use only, are provided in aerosol<br>cans and share the method of delivery/principle of operation. Slight variations | | | For use with: | High & Low speed<br>handpieces<br>and air motors | High & Low speed<br>handpieces<br>and air motors | High & Low speed<br>handpieces<br>and air motors | |
| Max Temperature | 120°F (49°C) | 120°F (49°C) | 120°F | | | | | |
| Contents | Lubricant plus<br>propellant | Lubricant plus<br>propellant | Lubricant plus<br>propellant | | | | | |
| Physical State | Aerosol Product | Aerosol Product | Aerosol Product | | | | | |

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# K163483

in the proprietary chemical formulation between PSP and the predicate Spray & Clean Handpiece Cleaner & Lubricant (K113674) result in slight differences in physical properties. Such slight differences due to proprietary formulations are to be expected and do not impact safety or effectiveness. PSP does not include any accessories.

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Summary of PSP has undergone reprocessing/cleaning validation to support the claim of Non-clinical cleaning in accordance with FDA guidance titled, "Reprocessing Medical Performance Devices in Health Care Settings: Validation Methods and Labeling". In addition, biocompatibility testing was conducted in accordance with Testing: ANSI/AAMI/ISO 10993-1 selection of tests for cytotoxicity, sensitization, and irritation. PANA SPRAY Plus continues to meet all NAKANISHI, INC. internal requirements for reliability (package vibration, unit drop, and temperature testing) and durability (repeated usage, actual usage, and contra/turbine testing). The test results indicate that PANA SPRAY Plus is substantially equivalent to the predicate devices and does not raise new questions of safety or efficacy.

> Comparison testing was conducted using predicate K113674 to demonstrate performance equivalence for bur extraction force, eccentricity, noise level, and stopping torque with all results being in compliance with ISO 14557.

- NAKANISHI, INC. considers PANA SPRAY Plus to be substantially Conclusion: equivalent to the predicate devices listed above. This conclusion is based on the similarities in primary intended use, principles of operation, functional design, and established medical use.