(369 days)
The Lubrina 2 is for lubricating and cleaning the inside of dental instruments.
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 provided text is a 510(k) premarket notification for the Lubrina 2, a dental handpiece accessory maintenance device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than novel performance benchmarks. Therefore, it does not contain the typical "acceptance criteria" and "device performance" in the way one might expect for a diagnostic or therapeutic medical device measured by clinical metrics.
Instead, the acceptance criteria are implicitly met by demonstrating that the Lubrina 2 is substantially equivalent to its predicate device, the Lubrina (Model HIM-1, K#070074), and by conforming to relevant international standards. The "study" that proves the device meets these criteria is a combination of non-clinical bench testing and a comparison of technological characteristics.
Here's the breakdown based on the provided document:
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Indications for Use | Substantially identical to predicate: Lubricating and cleaning the inside of dental instruments. | "Substantially identical" to predicate. Lubrina 2 is for lubricating and cleaning the inside of dental instruments. |
| Manufacturer | Identical to predicate. | Identical (J. MORITA MFG. CORP.) |
| Target Population | Identical to predicate: Dentist, doctor, dental hygienist or medical staff. Not for patient use. | Identical. Dentist, doctor, dental hygienist or medical staff. Not for patient use. |
| Where Used | Identical to predicate: Dental clinic, university hospital, and other clinical settings. | Identical. Dental clinic, university hospital, and other clinical settings. |
| Energy Used/Delivered | Identical to predicate: Rating AC100-240V, Input 10-25VA, Voltage 100-240V, Frequency 50/60Hz, Air Pressure 0.3-0.5MPa. | Identical to predicate. |
| Design (Size) | Similar to predicate (minor size difference W300×D300×H365mm vs W300×D300×H370mm). | Similar. Lubrina 2: W300xD300xH365mm. Predicate: W300xD300xH370mm. |
| Performance (Processing Time) | Similar to predicate, with potential for improvement. | Similar. Reduced processing time (40sec/piece) compared to predicate (120sec/piece). Reduced operating noise. |
| Standards Met | Identical to predicate in key standards: ISO 14971, IEC 62366, ISO 152231, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 62304. | Identical set of standards met. |
| Materials | Similar to predicate, no new questions of safety or effectiveness. | Similar, but with minor differences (e.g., Hot-dip zinc-coated steel vs Cold reduced carbon steel sheets, PBT/ABS vs ASA). These differences do not raise new safety/effectiveness questions. |
| Electrical Safety | In accordance with IEC60601-1, EN 62304, and ISO 14971. | In accordance with these standards. |
| Radiation Safety | In accordance with IEC60601-1-2. | In accordance with IEC60601-1-2. |
| Mechanical Safety | In accordance with IEC60601-1 and ISO 14971. | In accordance with these standards. |
| Thermal Safety | In accordance with IEC60601-1. | In accordance with IEC60601-1. |
| Anatomical Sites | Not applicable, identical to predicate. | Not applicable. Device not used on patient. |
| Sterility | Not applicable, identical to predicate. | Not applicable. Device not used on patient. |
| Human Factors | In accordance with IEC62366. | In accordance with IEC62366. |
| Compatibility with Environment and Other Devices | Conform to IEC60601-1-2. | Conform to IEC60601-1-2. |
| Functionality (Lubrication/Cleaning) | Capable of lubrication and cleaning handpieces. | Performance bench testing confirmed capability of lubrication and cleaning handpieces. |
| Compatibility with Lubricating Cans | Demonstrated compatibility with various lubricating cans. | Performance bench testing demonstrated compatibility. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in terms of number of devices or number of tests conducted. The document states "Testing was conducted to confirm that the device is capable of lubrication and cleaning handpieces" and "Performance bench testing was conducted to demonstrate the compatibility of the device with various lubricating cans." Specific quantities of tests or handpieces are not provided.
- Data Provenance: The tests are non-clinical bench tests, likely performed in a controlled laboratory environment by the manufacturer (J. Morita MFG. CORP). The country of origin for the testing is not explicitly stated, but the manufacturer is J. Morita MFG. CORP. (Japan), though J. Morita USA, Inc. is the submitter. The data is retrospective in the sense that the testing was completed prior to the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not applicable and not provided in the document. For a 510(k) submission of a device like Lubrina 2, which is an accessory maintenance device, ground truth in the sense of expert medical diagnosis or pathology is not relevant. The "ground truth" here is adherence to engineering standards and demonstrated functionality through bench testing.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies where expert consensus is needed to establish a medical ground truth, for example, in imaging diagnostics. For a device like Lubrina 2, which is assessed through engineering and performance bench tests, such adjudication is not relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. Such studies are typical for AI-powered diagnostic devices where human reader performance is a key metric. This device is a mechanical accessory maintenance unit.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
This question is not applicable as the Lubrina 2 is a mechanical device for cleaning and lubricating dental handpieces, not an algorithm, and does not involve human-in-the-loop performance in the context of an AI-driven system. Its performance is standalone in the sense that its function (lubricating and cleaning) does not directly involve human intervention during the process itself, but it's not an "algorithm only" performance.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established through engineering standards, functional bench testing, and comparison to the predicate device's established performance. It's not based on expert consensus, pathology, or outcomes data in a clinical sense. The device's ability to lubricate and clean handpieces, its electrical safety, electromagnetic compatibility, usability properties, and adherence to risk management principles constitute the "ground truth" that it performs as intended and is as safe/effective as the predicate.
8. The Sample Size for the Training Set
This information is not applicable and not provided. The Lubrina 2 is a mechanical accessory maintenance device and does not utilize a "training set" in the context of machine learning or artificial intelligence.
9. How the Ground Truth for the Training Set was Established
This information is not applicable. As the device does not employ a "training set," there is no ground truth to be established for it.
{0}------------------------------------------------
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
{1}------------------------------------------------
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
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
{4}------------------------------------------------
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:
{5}------------------------------------------------
Accompanying Items
| Name | Function | Note |
|---|---|---|
| Oil Absorbent Pad | Absorbing the drained oil in exhaust part | consumable;included in prior510(k) submissionfor LubrinaK#070074 |
| Oil Absorbent Sheet | Absorbing the drained oil in internal body | consumable;included in prior510(k) submissionfor LubrinaK#070074 |
| Power Cord | Electric power code for the USA | included in prior510(k) submissionfor LubrinaK#070074 |
| Air Tube | Providing air to main body | included in prior510(k) submissionfor LubrinaK#070074 |
| Door Oil Absorbent Sheet | Absorbing oil on the front door | consumable; notincluded in prior510(k) submissionfor LubrinaK#070074 |
| Front Door Sheet Stopper | Fixing the above Door Oil Absorbent Sheet | not included inprior 510(k)submission forLubrina K#070074 |
| Nozzle skirt | To prevent oil splashes during the chuck maintenance described in 7.3.2 of IFU | consumable;included in prior510(k) submissionfor LubrinaK#070074 |
{6}------------------------------------------------
| 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 standNSK standYOSHIDA 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 toLubrina 2 | not included inprior 510(k)submission forLubrina K#070074 |
| LS Coupling | To connect low speed handpieces(ISO3964 conformed) to Lubrina 2 | not included inprior 510(k)submission forLubrina K#070074 |
| 4H Coupling | To connect handpieces with 4-H joint toLubrina 2 | not included inprior 510(k)submission forLubrina K#070074 |
| KaVo Coupling | To connect handpieces with Kavo joint toLubrina 2 | not included inprior 510(k)submission forLubrina K#070074 |
{7}------------------------------------------------
| Name | Function | Note |
|---|---|---|
| W&H Coupling | To connect handpieces with W&H jointto Lubrina 2 | not included inprior 510(k)submission forLubrina K#070074 |
| Sirona Coupling | To connect handpieces with Sirona jointto Lubrina 2 | not included inprior 510(k)submission forLubrina K#070074 |
| TR-ZX2/DPCoupling | To connect J. Morita handpieces(TR-ZX2, DP-ZX-VL, and TR-CM) toLubrina 2 | not included inprior 510(k)submission forLubrina K#070074 |
| Tri Auto ZXCoupling | To connect Morita handpieces (TR-ZX)to Lubrina 2 | included in prior510(k) submissionfor LubrinaK#070074 |
| Coupling RubberGasket | Gasket for couplings which conforms toISO9168 type 3 | not included inprior 510(k)submission forLubrina 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:
{8}------------------------------------------------
| 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 forlubricating and cleaning theinside of dental instruments | LUBRINA HIM-1 is intendedfor internal cleaning, i.e.,purging of old lubricant, forthe maintenance of rotatingdental and surgicalinstruments. NOTE:LUBRINA HIM-1 should beused only with pre-cleaneddental handpieces and beforethey are sterilized. | Substantially identical |
| Target population | Dentist, doctor, dentalhygienist or medical staff.It is not used to the patient. | Dentist, doctor, dentalhygienist or medical staff.It is not used to the patient. | Identical |
| Where used | Dental clinic, universityhospital and the otherclinical settings | Dental clinic, universityhospital and the otherclinical settings | Identical |
| Energy used and/ordelivered | Rating AC100-240VInput 10-25VAVoltage 100-240VFrequency 50/60HzAir Pressure 0.3-0.5MPa | Rating AC100-240VInput 10-25VAVoltage 100-240VFrequency 50/60HzAir Pressure 0.3-0.5MPa | Identical |
| Design | Appearance New designSizeW300×D300×H365mm | SizeW300×D300×H370mm | Similar |
| Performance | - The maximum 4 piecesof handpieces are able tobe connected.- Two spray cans are setinside the box.Maximum processingtime:40sec/piece | - The maximum 4 pieces ofhandpieces are able to beconnected.- Two spray cans are setinside the box.Maximum processingtime:120sec/piece | SimilarReduced processing timecompared to the LubrinaReduced operating noisecompared to the Lubrina |
| Standards met | ISO 14971:2007, CorrectedVersion 2007-10-01IEC62366:2007+A1 2014ISO152231:2016,Correctedversion2017-03IEC60601-1:2005/A1:2012IEC60601-1-2:2014IEC60601-1-6:2010IEC62304:2006 | ISO 14971:2007, CorrectedVersion 2007-10-01IEC62366:2007+A1 2014ISO152231:2016,Correctedversion2017-03IEC60601-1:2005/A1:2012IEC60601-1-2:2014IEC60601-1-6:2010IEC 62304:2006 | Identical |
| Materials | Metal:• Stainless steel•Hot-dip zinc-coated steel• Aluminum• Copper alloy• Neodymium magnetPlasticASA, PPS, PVC, POM, PPRubberNitrile, Silicone, Fluoride | Metal:• Stainless steel•Hot-dip zinc-coated steel• Cold reduced carbon steelsheets• Aluminum• Copper alloyPlasticPBT/ABS, PPS, POM, PPRubberNitrile, Silicone, Fluoride | Similar |
| Submission Device | Predicate | Comparison result | |
| Product name | Lubrina 2 | Lubrina | - |
| Model | HIM-2 | HIM-1 | - |
| Electrical safety | In accordance withIEC60601-1, EN 62304and ISO 14971 | In accordance withIEC60601-1, EN 62304and ISO 14971 | Identical |
| Radiation safety | In accordance withIEC60601-1- 2 | In accordance withIEC60601-1-2 | Identical |
| Mechanicalsafety | In accordance withIEC60601-1 and ISO14971 | In accordance withIEC60601-1 and ISO14971 | Identical |
| Thermal safety | In accordance withIEC60601-1 | In accordance withIEC60601-1 | Identical |
| Anatomical sites | Not applicable | Not applicable | IdenticalThis device is not used tothe patient. |
| Sterility | Not applicable | Not applicable | IdenticalThis device is not used tothe patient. |
| Human factors | In accordance withIEC62366 | In accordance withIEC62366 | Identical |
| Compatibility withenvironment and otherdevices | Conform to IEC60601-1-2 | Conform to IEC60601-1-2 | Identical |
{9}------------------------------------------------
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."
{10}------------------------------------------------
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.
§ 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.