(143 days)
Not Found
No
The summary describes a mechanical device for cleaning dental instruments and makes no mention of AI or ML.
No
The device is described as a maintenance system for rotating dental and surgical instruments, used for internal cleaning (purging old lubricant) of these instruments, not for direct therapeutic use on patients.
No
Explanation: The device is intended for cleaning and maintenance of dental and surgical instruments, not for diagnosing any medical condition.
No
The device description explicitly states it consists of a "main body and several accessories" and describes physical components like a "box," "connection nut," and "spray cans." This indicates it is a hardware device, not software-only.
Based on the provided information, the LUBRINA HIM-1 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the "internal cleaning, i.e., purging of old lubricant, for the maintenance of rotating dental and surgical instruments." This is a maintenance function for medical devices, not a diagnostic test performed on biological samples.
- Device Description: The description details a system for connecting and cleaning handpieces using spray cans. This aligns with a maintenance device, not a device for analyzing biological specimens.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases, or providing diagnostic information.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, treatment, or prevention of disease. The LUBRINA HIM-1's function is entirely focused on the upkeep of medical instruments.
N/A
Intended Use / Indications for Use
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. CAUTION: FEDERAL (US) law restricts the use of this device to licensed professionals.
Product codes
EFB
Device Description
The LUBRINA HIM-1 is the maintenance system for handpieces, consisting of a main body and several accessories. The main body is constructed in a box on which the maximum 4 pieces of handpieces are able to be connected by each connection nut, and two spray cans are set inside the box.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed professionals (in a dental setting)
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
Attachment-6
510(k) SUMMARY J. Morita USA Inc.'s Lubrina HIM~1
Submitter Name and Address with Phone/Fax : l.
MAY 3 1 2007
Registration No. 2081055 Initial Distributor: J. Morita USA, Inc. 9 Mason Irvine, CA 92618 USA 949-581-9600 Telephone: Facsimile: 949-581-9688
Registration No. 3002807636 Manufacturer: J. MORITA MFG. CORP. 680 Higashihama Minami-cho Fushimi-ku, Kyoto Japan 612-8533 +81-75-611-2141 +81-75-605-2354
Contact Person 2.
Keith A. Barritt Fish & Richardson P.C. 1425 K Street, N.W. Suite 1100 Washington, DC 20005 Phone: (202) 783-5070 Facsimile: (202) 783-2331
Date summary prepared: 3.
December 20, 2006
Device Name: 4.
| Common/Usual Name: | Dental handpiece accessory for maintenance, cleaning and lubrication |
|---|---|
| Trade or Proprietary Name: | LUBRINA |
| Product Model Name ; | HIM-1 |
| Regulation Number: | 21 CFR § 872.4200 |
| Regulation Name : | Dental handpiece and accessories |
| Regulatory Class : | I |
| Product Code: | EFB |
| Classification Panel: | 872 Dental. |
1
5. Substantial Equivalency is claimed against the following device:
The LUBRINA HIM-1 is a maintenance system for handpieces, which is used in separate space apart from the patient and dentist. This is commonly used in dentistry, and the device is designed in a similar structure and performance.
· Predicate device
The HIM-1 is substantially equivalent to the Kavo QUATTROcare from KaVo America (K #012308) and the W & H Assistina from A-Dec, Inc. ( K #010127). The HIM-1 has similar general intended uses, similar principles of operation, and similar technological characteristics as the previously cleared predicate devices.
Although there are minor differences in the characteristics between the HIM-1 and its predicate device, these differences do not raise new questions of safety or effectiveness.
Description of the device: 6.
The LUBRINA HIM-1 is the maintenance system for handpieces, consisting of a main body and several accessories.
The main body is constructed in a box on which the maximum 4 pieces of handpieces are able to be connected by each connection nut, and two spray cans are set inside the box.
7. Indications for use
LUBLINA HIM-1 is intended for internal cleaning, i.e., purging of old lubricant, for the maintenance of rotating dental and surgical instruments.
LUBLINA HIM-1 should be used only with pre-cleaned dental handpieces NOTE: and before they are sterilized. CAUTION: FEDERAL(US) law restricts the use of this device to licensed professionals.
Safety and effectiveness of the device 8.
This device is safe and effective as the other predicate device cited above. This is better expressed in the tabulated comparison ( Section 9 at next page ).
2
Substantial Equivalent comparison table 9.
K0012308 and K0010127. FDA file reference number 510k number
| TECHNOLOGICAL CHARACTERISTICS | Comparison result |
|---|---|
| Indication for use | Identical |
| Target population | Identical |
| Design | Similar |
| Materials | Identical |
| Performance | Similar |
| Sterility | Identical |
| Biocompatibility | Identical |
| Mechanical safety | Identical |
| Chemical safety | Identical |
| Anatomical sites | Similar |
| Human factors | Similar |
| Energy used and/or delivered | Similar |
| Compatibility with environment and other devices | Similar |
| Where used | Identical |
| Standards met | Similar |
| Electrical safety | Similar |
| Thermal safety | Similar |
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
J. Morita USA, Incorporated C/O Mr. Keith A. Barritt Attorney Fish & Richardson P.C. 1425 K Street, N.W., Suite 1100 Washington, District of Columbia 20005 MAY 3 1 2007
Re: K070074
Trade/Device Name: LUBRINA HIM-1 Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: May 21, 2007 Received: May 22, 2007
Dear Mr. 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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
4
Page 2 - Mr. Barritt
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 moan mat r Dr mas mace a avtes and regulations administered by other Federal agencies. or the Act of any 1 ederal backed as a requirements, including, but not limited to: registration 1 ou must comply with an 07); labeling (21 CFR Part 801); good manufacturing practice allu listing (21 CFR Part 067), labeling systems (QS) regulation (21 CFR Part 820); and if requirenches as bet form in the quadistion control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) I mo reter will and in J . The FDA finding of substantial equivalence of your device to a promative month and device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 11 you don't the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may other of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Suyite Y. Michael mD.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
K070074
Indications for Use
510(k) Number (if known): Unknown
Device Name: LUBRINA HIM-1
Indications For Use:
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.
CAUTION: FEDERAL (US) law restricts the use of this device to licensed professionals.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR ·
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kein Wuly for KSR
sion of Anesthesiology, General Hospital, Jaction Control, Dental Devices
10(k) Number
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