PANA SPRAY PLUS

K131014 · Nsk America Corp. · EFB · Aug 12, 2013 · Dental

Device Facts

• Record ID: K131014
• Device Name: PANA SPRAY PLUS
• Applicant: Nsk America Corp.
• Product Code: EFB · Dental
• Decision Date: Aug 12, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1

Intended Use

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

Device Story

PANA SPRAY Plus is an alcohol-based lubricant for dental and surgical handpieces and air motors. Delivered via aerosol can; lubricant is introduced into handpiece through air-drive pipe or back end. Used by dental professionals in clinical settings for routine maintenance after each patient use and prior to sterilization. Ensures device reliability and durability.

Clinical Evidence

No clinical data. Bench testing only, including package vibration, unit drop, temperature testing, and durability testing (repeated usage, actual usage, and contra/turbine testing).

Technological Characteristics

Alcohol-based lubricant provided in aerosol cans. Manual delivery method. Class 1 device.

Indications for Use

Indicated for routine maintenance 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

• NSK America Pana-Spray (K052700)

Submission Summary (Full Text)

{0}------------------------------------------------

K 131014

NSK America Corporation

## 5. 510(k) SUMMARY

| Submitter: | NSK America<br>1800 Global Parkway<br>Hoffman Estates, IL 60192 |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Owner /<br>Contact Person: | Hirohiko Murase<br>Executive Vice President and General Manager<br>TEL: [phone]<br>FAX: [phone]<br>[e-mail] |
| Date Prepared: | April 5, 2013 |
| Trade Name: | PANA SPRAY Plus |
| Common Name: | Handpiece Lubricant |
| Classification Name: | Handpiece, Air-Powered, Dental (21 CFR 872.4200, Product Code FMC) |
| Classification: | Class 1 |
| Predicate Device: | K052700 NSK America Pana-Spray |
| Device Description: | PANA SPRAY Plus is an alcohol-based general handpiece and air-motor lubricant.<br>The lubricant is introduced into the handpiece through the air-drive pipe or the back<br>end. PANA SPRAY Plus can be used for the maintenance of high speed handpieces,<br>low speed handpieces, and air motors and should be used after each patient and<br>prior to sterilization of handpiece and air motors. |
| Statement of<br>Intended Use: | PANA SPRAY Plus is a lubricant intended to be used during routine maintenance of<br>dental and surgical handpieces after each patient use and prior to sterilization. |
| Summary of<br>Technological<br>Characteristics: | Both the proposed PANA SPRAY Plus and the predicate Pana Spray are lubricants<br>provided in aerosol cans for the maintenance of dental handpieces and air motors.<br>The method of delivery, function, and performance of the proposed and predicate<br>devices are the same. |
| Summary of<br>Non-Clinical Data:<br>Test Data: | PANA SPRAY Plus was evaluated to confirm that the device met NSK America<br>internal requirements for reliability (package vibration, unit drop, and temperature<br>testing) and durability (repeated usage, actual usage, and contra/turbine testing).<br>The test results indicate that PANA SPRAY Plus met all NSK America internal<br>requirements and is therefore substantially equivalent to the predicate device. |
| Conclusion: | NSK America considers PANA SPRAY Plus to be substantially equivalent to the<br>predicate device(s) listed above. This conclusion is based on the similarities in<br>primary intended use, principles of operation, functional design, and established<br>medical use. |

AUG 1 2 2013イ

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three branches of government. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

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

August 12, 2013

NSK America Corporation C/O Ms. Diane Rutherford Ken Block Consulting 1201 Richardson Drive, Suite 280 Richardson, Texas 75080

Re: K131014

Trade/Device Name: PANA SPRAY Plus Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: 1 Product Code: EFB Dated: July 17, 2013 Received: July 18, 2013

Dear Ms. 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.

{2}------------------------------------------------

Page 2 - Ms. Rutherford

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 the quality systems (QS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Image /page/2/Picture/6 description: The image shows the text "Mary S. Runner - S" in a simple, sans-serif font. The words are arranged horizontally, with "Mary" on the left, followed by "S. Runner" in the center, and "- S" on the right. The letters "FDA" are embedded in the text.

Kwame Ulmer, M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

## INDICATIONS FOR USE

510(k) Number: K13/014

Device Name: PANA SPRAY Plus

Indications for Use:

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

Prescription Use __ X (21 CFR 801 Subpart D)

AND/OR

Over-the-Counter Use (21 CFR 801 Subpart C)

## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

## Concurrence of CDHR, Office of Device Evaluation (ODE)

Sheena A. Green -S Sheena A. Green -5
2013.08.07 15:52:49 -04'00" 15-12:49 -04'00" 1

for M. Susan Runner, DDS, MA

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:_ K131014

Page 1 of 1

Section 4: Page 1 of 1