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.

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 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.

AI/ML Overview

The provided document is a 510(k) premarket notification for dental handpiece cleaners and lubricants. As such, it focuses on demonstrating substantial equivalence to a predicate device rather than establishing new acceptance criteria and proving performance against them in the same way a de novo device might.

Here's an analysis based on the document, addressing the requested points where applicable:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't define specific quantitative "acceptance criteria" in the traditional sense for a new device's performance benchmarks. Instead, it relies on demonstrating that the subject devices perform comparably to a legally marketed predicate device. The "acceptance criteria" are implicitly that the subject device's performance in the specified tests is equivalent to or better than the predicate device's performance, allowing it to meet its design performance requirements.

Comparison	Test	Method	Implicit Acceptance Criteria	Reported Device Performance
Spray & Clean Handpiece Cleaner & Lubricant vs. NSK Pana Spray	Handpiece Performance Testing	Cycle ( unspecified number of cycles) Bur extraction force,concentricity,noise level, and torque	Performance characteristics (bur extraction force, concentricity, noise level, torque) are comparable to the predicate.	"Met handpiece performance specification" (implies equivalence to predicate)
Maxima Handpiece Lubricant vs. NSK Pana Spray	Handpiece Performance Testing	Cycle (unspecified number of cycles) Bur extraction force,concentricity,noise level, and torque	Performance characteristics (bur extraction force, concentricity, noise level, torque) are comparable to the predicate.	"Met handpiece performance specification" (implies equivalence to predicate)

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify the sample size used for the test set (i.e., the number of handpieces or test iterations). It simply states that "performance testing... was conducted on the subject devices and the predicate device."

The data provenance is not explicitly stated regarding country of origin or whether it was retrospective or prospective. Given the nature of a 510(k) for a device like this, it is likely that the testing was conducted prospectively by the manufacturer or a contracted lab.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:

This type of information is generally not relevant for 510(k) submissions of accessories like handpiece lubricants. The "ground truth" here is objective physical and mechanical measurements of handpiece performance, not subjective expert assessment of clinical outcomes or images. Therefore, no experts were used in this capacity.

4. Adjudication Method for the Test Set:

Not applicable, as the "ground truth" is based on objective measurements, not expert consensus requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic or AI-assisted interpretation devices where human reader performance is a key metric. This device is a maintenance product for dental equipment.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Not applicable. This device is not an algorithm or an AI system. It is a physical product (lubricant). Performance is evaluated based on its effect on the mechanical function of dental handpieces.

7. The Type of Ground Truth Used:

The ground truth for the non-clinical testing was based on objective physical and mechanical measurements. Specifically, the test evaluated:

Bur extraction force
Concentricity
Noise level
Torque

These are measurable performance specifications for dental handpieces, which are expected to be maintained or improved by the lubricants.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/ML algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this type of device.

Summary

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K113674

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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 andLubricant.
Trade Name:	Spray & Clean Handpiece Cleaner & LubricantMaxima Handpiece Cleaner & LubricantEZCARE 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-powerDental, EFB

e- Substantial Equivalency is claimed against the following devices: PANA SPRAY lubricant oil by NSK America Corp. - K052700

f- Description of the device:

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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:

h - Device and Predicate Comparison Table:

DescriptiveInformation	Subject Device:	Predicate:
	Spray & Clean Handpiece Cleaner &Lubricant, Maxima HandpieceCleaner & Lubricant, and EZCAREHandpiece Cleaner & LubricantMaxima Handpiece Lubricant	NSK PANA SPRAYLUBRICANT OIL SUPERIORCLEANING &LUBRICANTNSK PANA SPRAYLUBRICANT OIL SUPERIORCLEANING &LUBRICANT
Indication of use	The Dental Handpiece Cleaner andLubricant is intended to be usedduring routine maintenance in order tolubricate and clean air-poweredDental Handpieces (including lowspeed and high speed) and Dental airmotors after each patient use andprior to sterilization.The Dental Handpiece Lubricant isintended to be used during routinemaintenance in order to lubricate air-powered Dental Handpieces(including low speed and high speed)and Dental air motors after eachpatient use and prior to sterilization.	This new device is a lubricantand is intended for use to cleanand lubricate the dental andmedical surgical handpieces.
Componentsname/Weightpercentage(% w/w)	Spray & Clean Handpiece Cleaner &Lubricant, Maxima HandpieceCleaner & Lubricant, and EZCAREHandpiece Cleaner & Lubricant(3 trade names carry the samechemical formula )Propellant: (84% w/w)Propane 7.5%n-Butane 17.5%Isopropanol 59%	PANA SPRAYPropellant: (63% w/w)PropaneIsobutanen-Butane

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	Lubricant: (16% w/w)Mineral oil 16%Hydrocarbon Range C16-C28 0%	Lubricant: (16% w/w)Petroleum OilHydrocarbon Range C16-C28
	Maxima Handpiece LubricantLubricant: (100% w/w)Severely refined Mineral oil 100%Hydrocarbon Range C16-C28 0%	Lubricant: (16% w/w)Petroleum OilHydrocarbon Range C16-C28
Fragrance	N/A	N/A

Physical Property comparison table:

Physical property	Predicate Device:Pana Spray Lubricant Oil	Subject Device:Spray & Clean HandpieceCleaner and Lubricant	Subject Device:Maxima HandpieceLubricant
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 °FConcentrate: 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 & CleanHandpieceCleaner &Lubricant vs.NSK Pana Spray	HandpiecePerformanceTesting	CycleBur extraction force,concentricity, noiselevel, and torque	Met handpieceperformancespecification
MaximaHandpieceLubricant vs.NSK Pana Spray	HandpiecePerformanceTesting	CycleBur extraction force,concentricity, noiselevel, and torque	Met handpieceperformancespecification

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.

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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.

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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.

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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

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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:

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: _______________________________________________________________________________________________________________________________________________________________

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.