LS OIL

K173920 · J. Morita USA, Inc. · EKX · Oct 11, 2018 · Dental

Device Facts

• Record ID: K173920
• Device Name: LS OIL
• Applicant: J. Morita USA, Inc.
• Product Code: EKX · Dental
• Decision Date: Oct 11, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1

Intended Use

LS OIL is a lubricant and is intended for use to lubricate dental handpieces.

Device Story

LS OIL is a dental handpiece lubricant; supplied in a 60ml bottle with a nozzle. Used in dental clinics, university hospitals, and clinical settings by dental staff. Applied manually by dropping oil into the hollow of high and low-speed handpieces after clinical use and before sterilization. Lubricates internal components including gears, bearings, and rotating parts. Benefits include maintenance of handpiece mechanical function and longevity. No energy source; non-sterile.

Clinical Evidence

No clinical data. Bench testing only. Performance testing compared LS OIL to LS SPRAY via simulated 6-year operation and autoclaving of contra angles, showing no abnormalities in sound or vibration. Biocompatibility testing performed per ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation and sensitization).

Technological Characteristics

Composition: paraffin oil and fatty acid ester (oiliness improver). No energy source. Dimensions: 60ml bottle, 135±10mm length, 35±5mm diameter. Non-sterile. Biocompatibility per ISO 10993; shelf life per ISO 14457; risk management per ISO 14971.

Indications for Use

Indicated for lubrication of dental handpieces for all patients in dentistry.

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 (K052700)

Reference Devices

• LS SPRAY (K170275)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font.

J. Mortia USA, Inc. % Keith Barritt Official Correspondent Fish & Richardson P.C. 1000 Maine Avenue S.W., Suite 1000 Washington, District of Columbia 20024

October 15, 2018

Re: K173920

Trade/Device Name: LS OIL Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: Class I Product Code: EKX Dated: September 11, 2018 Received: September 12, 2018

Dear Keith Barritt:

This letter corrects our substantially equivalent letter of October 11, 2018.

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/cfpmp/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.

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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Mary S. Runner -S3

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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| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|-----------------------------------------|
| Food and Drug Administration |

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

| 510(k) Number ( <i>if known</i> ) | |
|-----------------------------------|--|
|-----------------------------------|--|

K173920

Device Name

LS OIL

Indications for Use (Describe)

LS OIL is a lubricant and is intended for use to lubricate dental handpieces.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| <div> <span> <span style="text-decoration: underline;"></span>Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | <div> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |

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# K173920 510(k) SUMMARY J. Morita USA, Inc. LS OIL Dental Handpiece Lubricant

The following information is provided pursuant to 21 CFR 807.92.

## 21 CFR 807.92(a)(1): Submitter's Name and Address

#### (i) 510(k) Submitter

J. Morita USA, Inc. 9 Mason Irvine, CA 92618

#### (ii) 510(k) Submitter Contact

Keith A. Barritt Fish & Richardson P.C. 1000 Maine Avenue S.W., Suite 1000 Washington, DC 20024 Phone: [phone] Facsimile: [phone] Email: [e-mail]

#### (iii) Preparation Date

October 9, 2018

## 21 CFR 807.92(a)(2): Name of Device

Trade or Proprietary Name: LS OIL Common Name: dental handpiece lubricant Classification Name: dental handpiece and accessories Product Code: EKX Regulation: 21 C.F.R. 872.4200

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## 21 CFR 807.92(a)(3): Predicate Device

LS OIL is substantially equivalent to NSK America Corp.'s PANA-SPRAY dental device lubricant (K#052700). J. Morita's own LS SPRAY lubricant, cleared most recently as part of the Tri Auto ZX2 device under K#170275, is a reference device.

The LS SPRAY reference device contains only LS OIL plus liquid petroleum gas as a propellant. The liquid petroleum gas volatilizes immediately after spraying and has no effect on the efficacy of the LS OIL in the LS SPRAY.

The chart below provides a comparison of LS OIL, the predicate device PANA-SPRAY, and the reference device LS SPRAY.

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| | | | | Comparison between the LS OIL and Predicate and Reference Device | |
|--|--|--|--|------------------------------------------------------------------|--|
|--|--|--|--|------------------------------------------------------------------|--|

| Product name | LS OIL | Primary predicate<br>PANA SPRAY | Reference device<br>LS SPRAY | Similarities/<br>Differences |
|---------------------------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | J. MORITA MFG.<br>CORP. | NSK America Corp. | J. MORITA MFG.<br>CORP. | |
| 510(k) Number | pending | K052700 | K170275 | - |
| Intended use | Lubricant for dental<br>handpieces | Lubricant for<br>dental<br>handpieces | Lubricant for<br>dental<br>handpieces | Intended use for the<br>LS OIL is same as<br>the primary<br>predicate, PANA<br>SPRAY. |
| Indications for use | LS OIL is a lubricant<br>and is intended for<br>use to lubricate<br>dental handpieces. | PANA SPRAY is a<br>lubricant and is<br>intended for use to<br>lubricate the dental<br>handpieces and<br>medical surgical<br>handpieces. | As the LS SPRAY<br>was included as an<br>accessory to the Tri<br>Auto ZX2 under<br>K170275, there is no<br>separate indications<br>for use statement for<br>it; however, it is for<br>lubricating dental<br>handpieces, exactly<br>the same as for LS<br>OIL. | The Indications for Use<br>for the LS OIL are<br>nearly identical to and<br>within the indications<br>for the primary<br>predicate device, but<br>without reference to<br>"medical surgical<br>handpieces." |
| Patient population | All patients in<br>dentistry | Unknown | All patients in<br>dentistry | Patient population for<br>the LS OIL is same as<br>the reference device. |
| Anatomical sites | Limited duration<br>contact with intact<br>mucosal tissue | Unknown | Limited duration<br>contact with intact<br>mucosal tissue | Anatomical sites for<br>the LS OIL are same as<br>the reference device. |
| Use environment | Dental clinic,<br>University<br>hospital and other<br>clinical settings | Unknown | Dental clinic,<br>University hospital<br>and other clinical<br>settings | Use environment for<br>the LS OIL are same as<br>the reference device. |
| Energy used and/or<br>delivered | None | None | None | - |
| Product name | LS OIL | Primary predicate<br>PANA SPRAY | Reference device<br>LS SPRAY | Similarities/<br>Differences |
| Design/Materials | Oil and oiliness<br>improver (fatty acid<br>ester) for use as a<br>lubricant. | Ester lubricant,<br>additive, plus light<br>petroleum gas as a<br>propellant. | Oil and oiliness<br>improver (fatty acid<br>ester) for use as a<br>lubricant, plus light<br>petroleum gas as a<br>propellant. | Conclusion:<br>The LS OIL is the<br>nearly identical to the<br>primary predicate,<br>PANA SPRAY.<br>Comparison between<br>PANA SPRAY and LS<br>SPRAY:<br>The primary predicate,<br>PANA SPRAY,<br>contains ester lubricant<br>plus light petroleum<br>gas as a propellant,<br>which is identical to LS<br>SPRAY.<br>Comparison between<br>LS OIL and LS<br>SPRAY:<br>The difference between<br>the LS OIL and<br>reference device, LS<br>SPRAY, is that the LS<br>OIL does not contain<br>light petroleum gas. |
| Performance | No abnormalities<br>observed in gear<br>rotation or contra<br>angle | Unknown | No abnormalities<br>observed in gear<br>rotation or contra<br>angle | Performance is<br>functionally identical<br>to LS SPRAY as<br>demonstrated by<br>performance testing. |
| Sterility | LS OIL does not<br>come sterilized and<br>is not intended to be<br>sterilized separately<br>prior to use. | PANA SPRAY does<br>not come sterilized<br>and is not intended to<br>be sterilized<br>separately prior to<br>use. | LS SPRAY does not<br>come sterilized and is<br>not intended to be<br>sterilized separately<br>prior to use. | |
| For use with | High & Low speed<br>handpieces. | Unknown | High & Low speed<br>handpieces. | |

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## 21 CFR 807.92(a)(4): Device Description

LS OIL is a lubricant intended for use with dental handpieces. It is comprised of the same paraffin oil and oiliness improver (fatty acid ester) as the previouslycleared LS SPRAY reference device.

The device is depicted below:

Image /page/7/Figure/3 description: The image shows a diagram of a bottle with a nozzle and cap. The bottle has a volume of 60ml. The diagram includes measurements, with the total length of the bottle and nozzle being 135±10 units and the diameter of the bottle being φ35±5 units.

LS OIL is used after clinical use of dental handpieces before sterilization. It is directly added to the devices from its nozzle by dropping into inside of the handpieces. The LS OIL goes through the hollow of the devices and lubricates their components (gears, bearing, and rotating parts).

#### 21 CFR 807.92(a)(5): Indications for Use

LS OIL is a lubricant and is intended for use to lubricate the dental handpieces.

## 21 CFR 807.92(a)(6): Technological Characteristics

LS OIL has the same basic technological characteristics in terms of design, material, and chemical composition as LS SPRAY, except LS OIL does not have a light petroleum gas propellant as does LS SPRAY and thus the concentration of the oil in LS OIL is greater than the pre-application concentration of the oil in LS SPRAY, though the propellant in LS SPRAY dissipates upon application. LS OIL does not have an energy source.

#### 21 CFR 807.92(b)(1): Non-clinical Testing

Testing was conducted which shows that LS OIL has the same physical properties as LS SPRAY as follows:

Viscosity: 12 mm2/s at 15°C Solubility in Water: insoluble Density: 0.86 g/cm3 at 40°C Color: colorless

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Performance testing was conducted to compare LS OIL to LS SPRAY by applying the equivalent of six years of operation and autoclaving of contra angles with the two devices, which demonstrated no abnormalities in sound or vibration.

Shelf life was demonstrated pursuant to ISO 14457 and a comparison to the predicate device and a comparison of a stored and new sample of LS OIL regarding appearance, density, viscosity, water solubility, and infrared absorption.

Substantial biocompatibility testing was also conducted in accordance with ISO 10993 as follows:

Cytotoxicity (ISO 10993-5:2009(E), irritation (ISO 10993-10:2010(E), and sensitization (ISO 10993-10:2010(E)) studies of both the LS OIL and the reference device LS SPRAY.

Risk management principles of ISO 14971 were also followed in the development of LS OIL.

# 21 CFR 807.92(b)(2): Clinical Testing

There were no clinical tests performed for LS OIL.

## 21 CFR 807.92(b)(3): Conclusions from Testing

Based on the non-clinical testing conducted of the physical properties and the biocompatibility testing of LS OIL as described above, J. Morita USA, Inc. concludes that LS OIL is substantially equivalent to the PANA SPRAY predicate device identified above.