Lubrina 2
Device Facts
| Record ID | K190509 |
|---|---|
| Device Name | Lubrina 2 |
| Applicant | J. Morita USA, Inc. |
| Product Code | EFB · Dental |
| Decision Date | Mar 4, 2020 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.4200 |
| Device Class | Class 1 |
Indications for Use
The Lubrina 2 is for lubricating and cleaning the inside of dental instruments.
Device Story
Lubrina 2 is a tabletop maintenance device for dental handpieces; used after treatment and before autoclaving to prolong instrument life. Device accepts up to four handpieces and two internal spray lubricant cans. Operation involves automated delivery of pressurized air and oil to internal handpiece components; excess oil is removed via pressurized air. Four modes: Chuck Lubrication, Handpiece Body Lubrication, Flushing (Extended lubrication), and Air blow mode. Operated by dental staff in clinics or hospitals. Output is a cleaned, lubricated handpiece ready for sterilization. Benefits include consistent maintenance, reduced processing time, and lower operating noise compared to the predicate.
Clinical Evidence
No clinical data. Substantial equivalence is supported by non-clinical bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), usability (IEC 60601-1-6, IEC 62366), and software validation (IEC 62304).
Technological Characteristics
Tabletop device; dimensions 300x300x365mm. Materials: stainless steel, hot-dip zinc-coated steel, aluminum, copper alloy, neodymium magnet, ASA, PPS, PVC, POM, PP, nitrile, silicone, fluoride. Energy: AC 100-240V, 50/60Hz, 10-25VA; air pressure 0.3-0.5MPa. Connectivity: standalone. Standards: ISO 14971, IEC 62366, ISO 15223-1, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 62304.
Indications for Use
Indicated for lubricating and cleaning the inside of dental instruments. Intended for use by dentists, doctors, dental hygienists, or medical staff in clinical settings; not for use on patients.
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
- Lubrina (Model HIM-1) (K070074)
Submission Summary (Full Text)
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March 4, 2020
J. Mortia USA, Inc. % Keith Barritt Attorney Fish & Richardson P.C. 1000 Maine Ave. S.W. 9th floor Washington, District of Columbia 20024
Re: K190509
Trade/Device Name: Lubrina 2 Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: Class I, reserved Product Code: EFB Dated: December 4, 2019 Received: December 5, 2019
Dear Keith Barritt:
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/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.
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
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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 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).
Sincerely,
for Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K190509
Device Name Lubrina 2
Indications for Use (Describe)
The Lubrina 2 is for lubricating and cleaning the inside of dental instruments.
| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|
| <div style="display:flex; align-items:center;"> <div style="margin-right:5px;">☑</div> <div>Registration Use (Part 21 CFR 201 Subpart D)</div> </div> | <div style="display:flex; align-items:center;"> <div style="margin-right:5px;">☐</div> <div>Over-The-Counter Use (21 CFR 201 Subpart C)</div> </div> |
|-------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
> Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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## 510(k) Summary J. Morita USA Inc. Lubrina 2
#### Dental handpiece accessory maintenance, cleaning and lubrication
The following information is provided pursuant to 21 CFR 807.92.
#### 807.92(a)(1): Submitter's Name/Address, Contact, and Preparation Date
#### (i) 510(k) Submitter
J. Morita USA, Inc. 9 Mason Irvine, CA 92618 Phone: (949) 581-9600 FDA Reg. No.: 2081055
#### (ii) 510(k) Submitter Contact
Keith A. Barritt Fish & Richardson P.C. 1000 Maine Ave. S.W. Washington, DC 20024 (202) 783-5070 Phone: Phone: Facsimile: (202) 783-2331 Email: barritt@fr.com
## (iii) Preparation Date
March 4, 2020
#### 807.92(a)(2): Name of Device
Trade or Proprietary Name: Model Name: Common Name:
Classification Name: Primary Product Code: Classification Panel: Regulation:
Lubrina 2 HIM-2 Dental handpiece accessory maintenance, cleaning and lubrication Dental handpiece and accessories EFB 872 Dental 21 CFR 872.4200
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#### 807.92(a)(3): Predicate Devices
The Lubrina 2 device is substantially equivalent for purposes of FDA medical device regulations to J. MORITA MFG CORP.'s own Lubrina (Model HIM-1) (K#070074).
The Lubrina 2 has similar indication for use, similar principles of operation, and similar technological characteristics as the previous cleared Lubrina. Although there are minor differences in the characteristics between the Lubrina 2 and the original Lubrina, these differences do not raise new questions of safety or effectiveness.
#### 807.92(a)(4): Device Description
The Lubrina 2 device is used to maintain optimum performance and prolong the working life of dental handpieces. The Lubrina 2 delivers oil and air automatically to handpieces, and is used after dental treatment and before autoclaving. The Lubrina 2 is not installed in a dental operative unit, but rather is to be used on a table or shelf.
There is only one model. The type varies depending on the country/area the device is to be shipped to and the power cord for that region is included in the package. For the USA, only model HIM-2 Type US, is to be marketed, together with the power cord for the USA.
## Operating Mechanism:
The Lubrina 2 supplies lubrication oil to the inside of handpieces by automatically discharging pressurized air from spray can lubricant. Excess oil is removed from the handpiece by pressurized air.
The Lubrina 2 has four operation modes:
- Chuck Lubrication -
- Handpiece Body Lubrication -
- -Flushing (Extended lubrication)
- -Air blow mode
The accompanying items/components and the optional items are identified further in the charts below:
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# Accompanying Items
| Name | Function | Note |
|--------------------------|--------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| Oil Absorbent Pad | Absorbing the drained oil in exhaust part | consumable;<br>included in prior<br>510(k) submission<br>for Lubrina<br>K#070074 |
| Oil Absorbent Sheet | Absorbing the drained oil in internal body | consumable;<br>included in prior<br>510(k) submission<br>for Lubrina<br>K#070074 |
| Power Cord | Electric power code for the USA | included in prior<br>510(k) submission<br>for Lubrina<br>K#070074 |
| Air Tube | Providing air to main body | included in prior<br>510(k) submission<br>for Lubrina<br>K#070074 |
| Door Oil Absorbent Sheet | Absorbing oil on the front door | consumable; not<br>included in prior<br>510(k) submission<br>for Lubrina<br>K#070074 |
| Front Door Sheet Stopper | Fixing the above Door Oil Absorbent Sheet | not included in<br>prior 510(k)<br>submission for<br>Lubrina K#070074 |
| Nozzle skirt | To prevent oil splashes during the chuck maintenance described in 7.3.2 of IFU | consumable;<br>included in prior<br>510(k) submission<br>for Lubrina<br>K#070074 |
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| Name | Function | Note | |
|------------------------------------------|---------------------------------------------------------------------------|--------------------------------------------------------------|--------------------------------------------------------------|
| MORITA stand | A stand to fit the Morita type spray can to the Lubrina 2 | part of original Lubrina K#070074 | |
| KaVo stand<br>NSK stand<br>YOSHIDA stand | A stand to fit the KaVo, NSK, and YOSHIDA type spray can to the Lubrina 2 | not included in prior 510(k) submission for Lubrina K#070074 | |
| | W&H stand | A stand to fit the W&H type spray can to Lubrina 2 | not included in prior 510(k) submission for Lubrina K#070074 |
| | | Sirona stand | A stand to fit the Sirona type spray can to Lubrina 2 |
| Bien-Air stand | | | A stand to fit the Bien-Air type spray can to Lubrina 2 |
Accompanying Spray Stands for Compatible Sprays
# Optional Items
| Name | Function | Note |
|----------------|---------------------------------------------------------------------|-----------------------------------------------------------------------|
| Alpha Coupling | To connect handpieces with alpha joint to<br>Lubrina 2 | not included in<br>prior 510(k)<br>submission for<br>Lubrina K#070074 |
| LS Coupling | To connect low speed handpieces<br>(ISO3964 conformed) to Lubrina 2 | not included in<br>prior 510(k)<br>submission for<br>Lubrina K#070074 |
| 4H Coupling | To connect handpieces with 4-H joint to<br>Lubrina 2 | not included in<br>prior 510(k)<br>submission for<br>Lubrina K#070074 |
| KaVo Coupling | To connect handpieces with Kavo joint to<br>Lubrina 2 | not included in<br>prior 510(k)<br>submission for<br>Lubrina K#070074 |
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| Name | Function | Note |
|---------------------------|----------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| W&H Coupling | To connect handpieces with W&H joint<br>to Lubrina 2 | not included in<br>prior 510(k)<br>submission for<br>Lubrina K#070074 |
| Sirona Coupling | To connect handpieces with Sirona joint<br>to Lubrina 2 | not included in<br>prior 510(k)<br>submission for<br>Lubrina K#070074 |
| TR-ZX2/DP<br>Coupling | To connect J. Morita handpieces<br>(TR-ZX2, DP-ZX-VL, and TR-CM) to<br>Lubrina 2 | not included in<br>prior 510(k)<br>submission for<br>Lubrina K#070074 |
| Tri Auto ZX<br>Coupling | To connect Morita handpieces (TR-ZX)<br>to Lubrina 2 | included in prior<br>510(k) submission<br>for Lubrina<br>K#070074 |
| Coupling Rubber<br>Gasket | Gasket for couplings which conforms to<br>ISO9168 type 3 | not included in<br>prior 510(k)<br>submission for<br>Lubrina K#070074 |
## 807.92(a)(5): Indication for Use
The Lubrina 2 is for lubricating and cleaning the inside of dental instruments.
# 807.92(a)(6): Technological Characteristics
A comparison table of the technological characteristics of the Lubrina 2 and the predicate devices appears below:
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| | Submission Device | Predicate | Comparison result |
|--------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| Product name | Lubrina 2 | Lubrina | |
| Model | HIM-2 | HIM-1 | |
| Manufacturer | J. MORITA MFG. CORP. | J. MORITA MFG. CORP. | Identical |
| 510(k) Number | | K070074 | - |
| Indication for use | The Lubrina 2 is for<br>lubricating and cleaning the<br>inside of dental instruments | LUBRINA HIM-1 is intended<br>for internal cleaning, i.e.,<br>purging of old lubricant, for<br>the maintenance of rotating<br>dental and surgical<br>instruments. NOTE:<br>LUBRINA HIM-1 should be<br>used only with pre-cleaned<br>dental handpieces and before<br>they are sterilized. | Substantially identical |
| Target population | Dentist, doctor, dental<br>hygienist or medical staff.<br>It is not used to the patient. | Dentist, doctor, dental<br>hygienist or medical staff.<br>It is not used to the patient. | Identical |
| Where used | Dental clinic, university<br>hospital and the other<br>clinical settings | Dental clinic, university<br>hospital and the other<br>clinical settings | Identical |
| Energy used and/or<br>delivered | Rating AC100-240V<br>Input 10-25VA<br>Voltage 100-240V<br>Frequency 50/60Hz<br>Air Pressure 0.3-0.5MPa | Rating AC100-240V<br>Input 10-25VA<br>Voltage 100-240V<br>Frequency 50/60Hz<br>Air Pressure 0.3-0.5MPa | Identical |
| Design | Appearance New design<br><br>Size<br>W300×D300×H365mm | Size<br>W300×D300×H370mm | Similar |
| Performance | - The maximum 4 pieces<br>of handpieces are able to<br>be connected.<br>- Two spray cans are set<br>inside the box.<br>Maximum processing<br>time:40sec/piece | - The maximum 4 pieces of<br>handpieces are able to be<br>connected.<br>- Two spray cans are set<br>inside the box.<br>Maximum processing<br>time:120sec/piece | Similar<br>Reduced processing time<br>compared to the Lubrina<br>Reduced operating noise<br>compared to the Lubrina |
| Standards met | ISO 14971:2007, Corrected<br>Version 2007-10-01<br>IEC62366:2007+A1 2014<br>ISO152231:2016,Corrected<br>version2017-03<br>IEC60601-1:2005/A1:2012<br>IEC60601-1-2:2014<br>IEC60601-1-6:2010<br>IEC62304:2006 | ISO 14971:2007, Corrected<br>Version 2007-10-01<br>IEC62366:2007+A1 2014<br>ISO152231:2016,Corrected<br>version2017-03<br>IEC60601-1:2005/A1:2012<br>IEC60601-1-2:2014<br>IEC60601-1-6:2010<br>IEC 62304:2006 | Identical |
| Materials | Metal:<br>• Stainless steel<br>•Hot-dip zinc-coated steel<br>• Aluminum<br>• Copper alloy<br>• Neodymium magnet<br><br>Plastic<br>ASA, PPS, PVC, POM, PP<br><br>Rubber<br>Nitrile, Silicone, Fluoride | Metal:<br>• Stainless steel<br>•Hot-dip zinc-coated steel<br>• Cold reduced carbon steel<br>sheets<br>• Aluminum<br>• Copper alloy<br><br>Plastic<br>PBT/ABS, PPS, POM, PP<br><br>Rubber<br>Nitrile, Silicone, Fluoride | Similar |
| | Submission Device | Predicate | Comparison result |
| Product name | Lubrina 2 | Lubrina | - |
| Model | HIM-2 | HIM-1 | - |
| Electrical safety | In accordance with<br>IEC60601-1, EN 62304<br>and ISO 14971 | In accordance with<br>IEC60601-1, EN 62304<br>and ISO 14971 | Identical |
| Radiation safety | In accordance with<br>IEC60601-1- 2 | In accordance with<br>IEC60601-1-2 | Identical |
| Mechanical<br>safety | In accordance with<br>IEC60601-1 and ISO<br>14971 | In accordance with<br>IEC60601-1 and ISO<br>14971 | Identical |
| Thermal safety | In accordance with<br>IEC60601-1 | In accordance with<br>IEC60601-1 | Identical |
| Anatomical sites | Not applicable | Not applicable | Identical<br>This device is not used to<br>the patient. |
| Sterility | Not applicable | Not applicable | Identical<br>This device is not used to<br>the patient. |
| Human factors | In accordance with<br>IEC62366 | In accordance with<br>IEC62366 | Identical |
| Compatibility with<br>environment and other<br>devices | Conform to IEC60601-1-2 | Conform to IEC60601-1-2 | Identical |
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# 807.92(b)(1): Non-clinical Testing
The Lubrina 2 was tested for compliance and/or developed in accordance with the following international standards:
IEC60601-1:2005/A1:2012 Medical Electronic Equipment
This testing is designed to ensure the electrical safety of the device.
IEC 60601-1-2:2014 Electromagnetic Compatibility
This testing is designed to ensure the electromagnetic compatibility of the device when operated in its expected use environment.
IEC 60601-1-6:2010+A1:2013 Usability
This testing is designed to ensure reasonable device usability to minimize use errors and use-associated risks.
IEC 62304:2006 Medical Device Software
This testing is designed to ensure the software fulfills its intended purpose without causing any unacceptable risks. Software documentation was provided pursuant to the FDA's "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices."
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IEC 62366 :2007+A1 2014 Medical Devices - Application of Usability Engineering
This testing is designed to analyze, specify, design, verify and validate usability as it relates to safety of a medical device. This usability engineering process assesses and mitigates risks caused by usability problems associated with correct use and use errors, i.e. normal use.
ISO 14971: 2007, Corrected Version 2007-10-0 - Application of Risk Management to Medical Devices
This standard provides a framework for systematically managing the risks associated with the use of medical devices. It addresses processes for managing risks, primarily to the patient, but also to the operator, other persons, other equipment, and the environment.
ISO 15223-1:2016 Medical Devices – Symbols Used with Medical Device Labels
This standard identifies requirements for symbols used in medical device labeling that convey information on the safe and effective use of medical devices.
Testing was conducted to confirm that the device is capable of lubrication and cleaning handpieces and the device was shown to be substantially equivalent to the predicate. Performance bench testing was conducted to demonstrate the compatibility of the device with various lubricating cans.
In summary, the non-clinical testing establishes that the device is substantially equivalent to the predicate device.
## 807.92(b)(2): Clinical Testing
There were no clinical tests performed for Lubrina 2.
## 807.92(b)(3): Conclusions from Testing
Based on the comparison of Lubrina 2 to the predicate device identified above, and based on the data gathered in the non-clinical testing described above, it is concluded that the data provided in this 510(k) submission demonstrates that Lubrina 2 is substantially equivalent to the predicate devices.
