(113 days)
Not Found
No
The device description and intended use clearly define a chemical cleaning and lubrication product, with no mention of software, algorithms, or any form of intelligent processing.
No.
The device is described as a cleaner and lubricant for dental handpieces for routine maintenance prior to sterilization, not for directly treating a patient's condition or disease.
No
This device is a cleaner and lubricant for dental handpieces, intended for routine maintenance. It does not diagnose any condition or disease.
No
The device description clearly states it is an aerosol product containing mineral oil and isopropyl alcohol, 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 clearly stated as "routine maintenance in order to lubricate and clean air-powered Dental Handpieces and Dental air motors." This is a maintenance function for a medical device (the handpiece), not a diagnostic test performed on a biological sample.
- Device Description: The device is described as an aerosol product or a liquid containing mineral oil and isopropyl alcohol, used to lubricate and clean internal parts of the handpiece. This aligns with a maintenance product, not a diagnostic reagent or instrument.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing information for the diagnosis, monitoring, or treatment of a disease or condition.
- Performance Study: The performance study focuses on "Handpiece Performance Testing," which evaluates the effectiveness of the lubricant/cleaner on the handpiece itself, not on a diagnostic outcome.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Dental Handpiece Cleaner and Lubricant is intended to be used during routine maintenance in order to lubricate and clean air-powered Dental Handpieces (including low speed and high speed) and Dental air motors after each patient use and prior to sterilization.
The Dental Handpiece Lubricant is intended to be used during routine maintenance in order to lubricate air-powered Dental Handpieces (including low speed and high speed) and Dental air motors after each patient use and prior to sterilization.
Product codes (comma separated list FDA assigned to the subject device)
EFB
Device Description
Dental Handpiece Cleaner and Lubricant (Spray & Clean Handpiece Cleaner & Lubricant, Maxima Handpiece Cleaner & Lubricant, and EZcare Handpiece Cleaner & Lubricant), This is an aerosol product that is used during routine maintenance. It contains two major components, which are Mineral oil and Isopropyl Alcohol. The product lubricates and cleans dental handpieces and air motors when sprayed directly into the air drive tube. It lubricates and cleans out contamination from all internal parts, such as the bearings, gears and auto chucks.
Dental Handpiece Lubricant: Maxima Handpiece Lubricant
Maxima Handpiece Lubricant contains mineral oil that drops directly into the air drive tube of the dental handpiece. When the user operates the handpiece, the pressure of air in the air drive tube will deliver the oil into the handpiece to lubricate the bearings, gears, and auto chucks.
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
Not Found
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)
The table below provides a general summary of the performance testing which was conducted on the subject devices and the predicate device. The testing results indicate that the subject devices meet their design performance requirements.
Test: Handpiece Performance Testing
Method: Cycle Bur extraction force, concentricity, noise level, and torque
Conclusion: Met handpiece performance specification
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.
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
§ 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/2 description: The image shows the words "Handpiece Headquarters" in a bold, stylized font. Above the words is a line graph. The text is the main focus of the image.
A Henry Schein® COMPANY
510(K) SUMMARY:
- a- Submitted by: HANDPIECE HEADQUARTERS 620 S. Placentia Ave., Placentia CA 92870 Tel. 714-579-0175 Fax. 714-579-0186
- b- Contact person: Tina Steffanie-Oak, Tel. 717-335-7230, ext. 4150 Fax. 717-335-7240 Email: tina.steffanie-oak@henryschein.com
c- Date summary prepared: 04/2/2012
d- Device Name:
| Common Name: | Dental Handpiece and Accessories, Dental Handpiece Cleaner and
Lubricant. |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name: | Spray & Clean Handpiece Cleaner & Lubricant
Maxima Handpiece Cleaner & Lubricant
EZCARE Handpiece Cleaner & Lubricant
(3 trade names carry the same chemical formula ) |
| Common Name: | Dental Handpiece and Accessories, Dental Handpiece Lubricant. |
| Trade Name: | Maxima Handpiece Lubricant |
| Classification Name: | Class I Device, 21 CFR 872.4200, Handpiece, Air-power
Dental, EFB |
e- Substantial Equivalency is claimed against the following devices: PANA SPRAY lubricant oil by NSK America Corp. - K052700
f- Description of the device:
Dental Handpiece Cleaner and Lubricant (Spray & Clean Handpiece Cleaner & Lubricant, Maxima Handpiece Cleaner & Lubricant, and EZcare Handpiece Cleaner & Lubricant), This is an aerosol product that is used during routine maintenance. It contains two major components, which are Mineral oil and Isopropyl Alcohol. The product lubricates and cleans dental handpieces and air motors when sprayed directly into the air drive tube. It lubricates and cleans out contamination from all internal parts, such as the bearings, gears and auto chucks.
1
Dental Handpiece Lubricant: Maxima Handpiece Lubricant
Maxima Handpiece Lubricant contains mineral oil that drops directly into the air drive tube of the dental handpiece. When the user operates the handpiece, the pressure of air in the air drive tube will deliver the oil into the handpiece to lubricate the bearings, gears, and auto chucks.
g- Statement of Intended Use:
The Dental Handpiece Cleaner and Lubricant is intended to be used during routine maintenance in order to lubricate and clean air-powered Dental Handpieces (including low speed and high speed) and Dental air motors after each patient use and prior to sterilization.
The Dental Handpiece Lubricant is intended to be used during routine maintenance in order to lubricate air-powered Dental Handpieces (including low speed and high speed) and Dental air motors after each patient use and prior to sterilization.
h - Device and Predicate Comparison Table:
| Descriptive
| Information | Subject Device: | Predicate: |
|---|---|---|
| Spray & Clean Handpiece Cleaner & | ||
| Lubricant, Maxima Handpiece | ||
| Cleaner & Lubricant, and EZCARE | ||
| Handpiece Cleaner & Lubricant |
Maxima Handpiece Lubricant | NSK PANA SPRAY
LUBRICANT OIL SUPERIOR
CLEANING &LUBRICANT
NSK PANA SPRAY
LUBRICANT OIL SUPERIOR
CLEANING &LUBRICANT |
| Indication of use | The Dental Handpiece Cleaner and
Lubricant is intended to be used
during routine maintenance in order to
lubricate and clean air-powered
Dental Handpieces (including low
speed and high speed) and Dental air
motors after each patient use and
prior to sterilization.
The Dental Handpiece Lubricant is
intended to be used during routine
maintenance in order to lubricate air-
powered Dental Handpieces
(including low speed and high speed)
and Dental air motors after each
patient use and prior to sterilization. | This new device is a lubricant
and is intended for use to clean
and lubricate the dental and
medical surgical handpieces. |
| Components
name/
Weight
percentage
(% w/w) | Spray & Clean Handpiece Cleaner &
Lubricant, Maxima Handpiece
Cleaner & Lubricant, and EZCARE
Handpiece Cleaner & Lubricant
(3 trade names carry the same
chemical formula )
Propellant: (84% w/w)
Propane 7.5%
n-Butane 17.5%
Isopropanol 59% | PANA SPRAY
Propellant: (63% w/w)
Propane
Isobutane
n-Butane |
2
| | Lubricant: (16% w/w)
Mineral oil 16%
Hydrocarbon Range C16-C28 0% | Lubricant: (16% w/w)
Petroleum Oil
Hydrocarbon Range C16-C28 |
|-----------|--------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|
| | Maxima Handpiece Lubricant
Lubricant: (100% w/w)
Severely refined Mineral oil 100%
Hydrocarbon Range C16-C28 0% | Lubricant: (16% w/w)
Petroleum Oil
Hydrocarbon Range C16-C28 |
| Fragrance | N/A | N/A |
Physical Property comparison table:
| Physical property | Predicate Device:
Pana Spray Lubricant Oil | Subject Device:
Spray & Clean Handpiece
Cleaner and Lubricant | Subject Device:
Maxima Handpiece
Lubricant |
|---------------------|-----------------------------------------------|---------------------------------------------------------------------|--------------------------------------------------|
| Physical State | Aerosol Product | Aerosol Product | Transparent Water-white Liquid |
| Color | clear | Clear | Clear |
| Solubility in Water | Insoluble | Insoluble | Insoluble |
| Specific Gravity | $0.63 \ (H_2O=1)$ | .70-.90 g/cc | $0.835 @ 15.6 \degree C \ (H_2O=1)$ |
| Boiling Point | -44 deg F-31 deg F | Propellant: 7.29 °F
Concentrate: 180 °F | 310 °C (590 °F) |
| Viscosity | n/a | n/a | n/a |
i - Description of Non-Clinical Test Data used to support SE Decision:
The table below provides a general summary of the performance testing which was conducted on the subject devices and the predicate device. The testing results indicate that the subject devices meet their design performance requirements.
| Comparison | Test | Method | Conclusion |
|---|---|---|---|
| Spray & Clean | |||
| Handpiece | |||
| Cleaner & | |||
| Lubricant vs. | |||
| NSK Pana Spray | Handpiece | ||
| Performance | |||
| Testing | Cycle | ||
| Bur extraction force, | |||
| concentricity, noise | |||
| level, and torque | Met handpiece | ||
| performance | |||
| specification | |||
| Maxima | |||
| Handpiece | |||
| Lubricant vs. | |||
| NSK Pana Spray | Handpiece | ||
| Performance | |||
| Testing | Cycle | ||
| Bur extraction force, | |||
| concentricity, noise | |||
| level, and torque | Met handpiece | ||
| performance | |||
| specification |
j - Description of Clinical Test Data used to support SE Decision:
Clinical test data was not required to support our substantial equivalence determination.
k - Conclusions Drawn from Non-Clinical Data:
Based on the information provided in this submission Handpiece Headquarters believes that the Dental Handpiece Cleaner & Lubricant and Dental Handpiece Lubricant are intended for the same use and are substantially equivalent to the predicate devices identified.
3
l – Biocompatibility: Biocompatibility testing has not been conducted on the subject devices, because the chemical components have already been incorporated in legally marketed devices with similar conditions of use and have a demonstrated history of biocompatibility.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Tina Steffanie-Oak Consultant Handpiece Headquarters Inc, - HPR Inc. 620 S. Placentia Avenue Placentia, California 92870
APR - 5 2012
Re: K113674
Trade/Device Name: Dental Handpiece Cleaner and Lubricant, and a Dental Handpiece Lubricant (sold under these brand names Spray & Clean Handpiece Cleaner & Lubricant, Maxima Handpiece Cleaner & Lubricant, EZcare Handpiece Cleaner & Lubricant, and Maxima Handpiece Lubricant)
Regulation Number: 21 CFR 872.4200
Regulation Name: Dental Handpiece and Accessories
Regulatory Class: I
Product Code: EFB
Dated: April 2, 2012
Received: April 3, 2012
Dear Ms. Steffanie-Oak:
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. 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.
5
Page 2 - Ms. Steffanie-Oak
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Nh for
Anthony D. Watson, B.S., M.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
113672
510(k) Number (if known):
Device Name: Dental Handpiece Cleaner and Lubricant, and a Dental Handpiece Lubricant (sold under these brand names Spray & Clean Handpiece Cleaner & Lubricant, Maxima Handpiece Cleaner & Lubricant, EZcare Handpiece Cleaner & Lubricant, and Maxima Handpiece Lubricant)
Indications for Use:
The Dental Handpiece Cleaner and Lubricant is intended to be used during routine maintenance in order to lubricate and clean air-powered Dental Handpieces (including low speed and high speed) and Dental air motors after each patient use and prior to sterilization.
The Dental Handpiece Lubricant is intended to be used during routine maintenance in order to lubricate air-powered Dental Handpieces (including low speed and high speed) and Dental air motors after each patient use and prior to sterilization.
Prescription Use X (Per 21 CFR 801 Subpart D) Subpart C)
AND/OR
Over-The-Counter Use
(Per 21 CFR 801
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Othuraltneen for MSR
Page 1 of 1
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: _______________________________________________________________________________________________________________________________________________________________