(293 days)
K#052700
K#170275
No
The device description and intended use clearly state it is a lubricant for dental handpieces, and there is no mention of AI or ML in any section of the summary.
No
The device is described as a lubricant for dental handpieces, intended to lubricate their components. It does not treat or diagnose any medical condition, nor does it affect the structure or function of the body.
No
Explanation: The device is a lubricant for dental handpieces. Its purpose is to lubricate components (gears, bearings, rotating parts) of dental handpieces after clinical use and before sterilization, not to diagnose a medical condition or disease.
No
The device description clearly states it is a lubricant comprised of paraffin oil and fatty acid ester, which are physical substances, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "lubricate dental handpieces." This is a mechanical function, not a diagnostic one.
- Device Description: The description details a lubricant for mechanical components of dental handpieces. It does not mention any interaction with biological samples or diagnostic procedures.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health condition.
- Anatomical Site: While it has limited duration contact with intact mucosal tissue, this is a consequence of its use on a dental device, not its primary function as a diagnostic tool.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
LS OIL is a lubricant and is intended for use to lubricate dental handpieces.
Product codes
EKX
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 previously cleared LS SPRAY reference device. 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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Limited duration contact with intact mucosal tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dental clinic, University hospital and other clinical settings
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K#052700
Reference Device(s)
K#170275
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). 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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 ( if known ) | |
|---|---|
| ----------------------------------- | -- |
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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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: (202) 783-5070 Facsimile: (202) 783-2331 Email: barritt@fr.com
(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
PANA SPRAY | Reference device
LS SPRAY | Similarities/
Differences |
|---------------------------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | J. MORITA MFG.
CORP. | NSK America Corp. | J. MORITA MFG.
CORP. | |
| 510(k) Number | pending | K052700 | K170275 | - |
| Intended use | Lubricant for dental
handpieces | Lubricant for
dental
handpieces | Lubricant for
dental
handpieces | Intended use for the
LS OIL is same as
the primary
predicate, PANA
SPRAY. |
| Indications for use | LS OIL is a lubricant
and is intended for
use to lubricate
dental handpieces. | PANA SPRAY is a
lubricant and is
intended for use to
lubricate the dental
handpieces and
medical surgical
handpieces. | As the LS SPRAY
was included as an
accessory to the Tri
Auto ZX2 under
K170275, there is no
separate indications
for use statement for
it; however, it is for
lubricating dental
handpieces, exactly
the same as for LS
OIL. | The Indications for Use
for the LS OIL are
nearly identical to and
within the indications
for the primary
predicate device, but
without reference to
"medical surgical
handpieces." |
| Patient population | All patients in
dentistry | Unknown | All patients in
dentistry | Patient population for
the LS OIL is same as
the reference device. |
| Anatomical sites | Limited duration
contact with intact
mucosal tissue | Unknown | Limited duration
contact with intact
mucosal tissue | Anatomical sites for
the LS OIL are same as
the reference device. |
| Use environment | Dental clinic,
University
hospital and other
clinical settings | Unknown | Dental clinic,
University hospital
and other clinical
settings | Use environment for
the LS OIL are same as
the reference device. |
| Energy used and/or
delivered | None | None | None | - |
| Product name | LS OIL | Primary predicate
PANA SPRAY | Reference device
LS SPRAY | Similarities/
Differences |
| Design/Materials | Oil and oiliness
improver (fatty acid
ester) for use as a
lubricant. | Ester lubricant,
additive, plus light
petroleum gas as a
propellant. | Oil and oiliness
improver (fatty acid
ester) for use as a
lubricant, plus light
petroleum gas as a
propellant. | Conclusion:
The LS OIL is the
nearly identical to the
primary predicate,
PANA SPRAY.
Comparison between
PANA SPRAY and LS
SPRAY:
The primary predicate,
PANA SPRAY,
contains ester lubricant
plus light petroleum
gas as a propellant,
which is identical to LS
SPRAY.
Comparison between
LS OIL and LS
SPRAY:
The difference between
the LS OIL and
reference device, LS
SPRAY, is that the LS
OIL does not contain
light petroleum gas. |
| Performance | No abnormalities
observed in gear
rotation or contra
angle | Unknown | No abnormalities
observed in gear
rotation or contra
angle | Performance is
functionally identical
to LS SPRAY as
demonstrated by
performance testing. |
| Sterility | LS OIL does not
come sterilized and
is not intended to be
sterilized separately
prior to use. | PANA SPRAY does
not come sterilized
and is not intended to
be sterilized
separately prior to
use. | LS SPRAY does not
come sterilized and is
not intended to be
sterilized separately
prior to use. | |
| For use with | High & Low speed
handpieces. | Unknown | High & Low speed
handpieces. | |
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7
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
Page 5 of 6
8
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.