Predicate Devices

K#070074

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on mechanical operation (delivering oil and air) and different modes of operation, with no mention of AI/ML terms or capabilities.

Therapeutic

No
The device is used for maintaining dental instruments, not for treating patients or conditions.

Diagnostic

No

The device is used for cleaning and lubricating dental instruments to maintain their performance and prolong their working life. It does not diagnose any condition or disease.

SaMD (Software as a Medical Device)

No

The device description clearly describes a physical device that delivers oil and air to dental handpieces, indicating it is a hardware device with a mechanical operating mechanism.

IVD (In Vitro Diagnostic)

Based on the provided information, the Lubrina 2 device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is "for lubricating and cleaning the inside of dental instruments." This is a maintenance function for medical devices, not a diagnostic test performed on biological samples.
Device Description: The description details a device that applies oil and air to dental handpieces. This is a mechanical process for device upkeep.
Operating Mechanism: The mechanism involves pressurized air and lubricant to clean and maintain instruments. This is not a method for analyzing biological specimens.
Anatomical Site: The device is used on dental instruments, not on a patient's anatomy.
Intended User / Care Setting: While used in a clinical setting by medical staff, the device's function is on the instruments, not for diagnosing or treating a patient.

IVD devices are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment. The Lubrina 2 does not perform any such tests.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Lubrina 2 is for lubricating and cleaning the inside of dental instruments.

Product codes (comma separated list FDA assigned to the subject device)

EFB

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not applicable

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Dentist, doctor, dental hygienist or medical staff. It is not used to the patient.
Dental clinic, university hospital and the 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 bench testing was conducted to demonstrate the compatibility of the device with various lubricating cans. 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K#070074

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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.

Summary

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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, there is a symbol representing the Department of Health & Human Services-USA. To the right, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".

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

2

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)
-------------------------------------------------

☑ Registration Use (Part 21 CFR 201 Subpart D)	☐ Over-The-Counter Use (21 CFR 201 Subpart C)
-------------------------------------------------------------------------------------------------------------------------------------------------------	------------------------------------------------------------------------------------------------------------------------------------------------------

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;
included in prior
510(k) submission
for Lubrina
K#070074
Oil Absorbent Sheet	Absorbing the drained oil in internal body	consumable;
included in prior
510(k) submission
for Lubrina
K#070074
Power Cord	Electric power code for the USA	included in prior
510(k) submission
for Lubrina
K#070074
Air Tube	Providing air to main body	included in prior
510(k) submission
for Lubrina
K#070074
Door Oil Absorbent Sheet	Absorbing oil on the front door	consumable; not
included in prior
510(k) submission
for Lubrina
K#070074
Front Door Sheet Stopper	Fixing the above Door Oil Absorbent Sheet	not included in
prior 510(k)
submission for
Lubrina K#070074
Nozzle skirt	To prevent oil splashes during the chuck maintenance described in 7.3.2 of IFU	consumable;
included in prior
510(k) submission
for Lubrina
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
NSK stand
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
Lubrina 2	not included in
prior 510(k)
submission for
Lubrina K#070074
LS Coupling	To connect low speed handpieces
(ISO3964 conformed) to Lubrina 2	not included in
prior 510(k)
submission for
Lubrina K#070074
4H Coupling	To connect handpieces with 4-H joint to
Lubrina 2	not included in
prior 510(k)
submission for
Lubrina K#070074
KaVo Coupling	To connect handpieces with Kavo joint to
Lubrina 2	not included in
prior 510(k)
submission for
Lubrina K#070074

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Name	Function	Note
W&H Coupling	To connect handpieces with W&H joint
to Lubrina 2	not included in
prior 510(k)
submission for
Lubrina K#070074
Sirona Coupling	To connect handpieces with Sirona joint
to Lubrina 2	not included in
prior 510(k)
submission for
Lubrina K#070074
TR-ZX2/DP
Coupling	To connect J. Morita handpieces
(TR-ZX2, DP-ZX-VL, and TR-CM) to
Lubrina 2	not included in
prior 510(k)
submission for
Lubrina K#070074
Tri Auto ZX
Coupling	To connect Morita handpieces (TR-ZX)
to Lubrina 2	included in prior
510(k) submission
for Lubrina
K#070074
Coupling Rubber
Gasket	Gasket for couplings which conforms to
ISO9168 type 3	not included in
prior 510(k)
submission for
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
lubricating and cleaning the
inside of dental instruments	LUBRINA HIM-1 is intended
for internal cleaning, i.e.,
purging of old lubricant, for
the maintenance of rotating
dental and surgical
instruments. NOTE:
LUBRINA HIM-1 should be
used only with pre-cleaned
dental handpieces and before
they are sterilized.	Substantially identical
Target population	Dentist, doctor, dental
hygienist or medical staff.
It is not used to the patient.	Dentist, doctor, dental
hygienist or medical staff.
It is not used to the patient.	Identical
Where used	Dental clinic, university
hospital and the other
clinical settings	Dental clinic, university
hospital and the other
clinical settings	Identical
Energy used and/or
delivered	Rating AC100-240V
Input 10-25VA
Voltage 100-240V
Frequency 50/60Hz
Air Pressure 0.3-0.5MPa	Rating AC100-240V
Input 10-25VA
Voltage 100-240V
Frequency 50/60Hz
Air Pressure 0.3-0.5MPa	Identical
Design	Appearance New design

Two spray cans are set
inside the box.
Maximum processing
time:40sec/piece | - The maximum 4 pieces of
handpieces are able to be
connected.
Two spray cans are set
inside the box.
Maximum processing
time:120sec/piece | Similar
Reduced processing time
compared to the Lubrina
Reduced operating noise
compared to the Lubrina |
| Standards met | ISO 14971:2007, Corrected
Version 2007-10-01
IEC62366:2007+A1 2014
ISO152231:2016,Corrected
version2017-03
IEC60601-1:2005/A1:2012
IEC60601-1-2:2014
IEC60601-1-6:2010
IEC62304:2006 | ISO 14971:2007, Corrected
Version 2007-10-01
IEC62366:2007+A1 2014
ISO152231:2016,Corrected
version2017-03
IEC60601-1:2005/A1:2012
IEC60601-1-2:2014
IEC60601-1-6:2010
IEC 62304:2006 | Identical |
| Materials | Metal:
• Stainless steel
•Hot-dip zinc-coated steel
• Aluminum
• Copper alloy
• Neodymium magnet

Plastic
ASA, PPS, PVC, POM, PP

Rubber
Nitrile, Silicone, Fluoride | Metal:
• Stainless steel
•Hot-dip zinc-coated steel
• Cold reduced carbon steel
sheets
• Aluminum
• Copper alloy

Plastic
PBT/ABS, PPS, POM, PP

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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.