The Lares Research 557 and 757 ProStyle model product family of high-speed handpieces is intended to be used by licensed dental professionals to reduce hard tooth structure, carry out cavity preparations and perform restorative dentistry.

Device Description

The Lares Research 557 and 757 ProStyle model product family of high-speed handpieces are the next generation of the Lares high-speed handpiece product line. The Lares Research 557 and 757 ProStyle model product family of highspeed handpieces are substantially similar to the 557 Turbo+ and 757 Workhorse as they are light weight, air-driven high-speed turbine dental drills connected to standard ISO 9168 Type 2 and Type 3 dental unit hose connections. The Lares Research 557 and 757 ProStyle model product family of high-speed handpieces features include a solid glass fiber optic element and optional Kavo Multi-Flex compatible swivel quick connection.

AI/ML Overview

This document describes the premarket notification (510(k)) for the Lares Research 557 and 757 ProStyle model product family of high-speed handpieces. The document focuses on demonstrating substantial equivalence to existing predicate devices rather than proving performance against specific acceptance criteria through a standalone study with a defined ground truth.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present a formal table of acceptance criteria with corresponding device performance metrics in the way one might expect for a diagnostic or AI device. Instead, it relies on a comparison of technological characteristics and compliance with a general standard.

Product Characteristic	Lares 557 ProStyle & 757 ProStyle Model Product Family (New Device)	Predicate Devices (e.g., Lares 557 Turbo+, Lares 757 Workhorse, Kavo 6000B)	Assessment
Indications for Use	"reduce hard tooth structure, carry out cavity preparations and perform restorative dentistry."	Equivalent	Equivalent - The new device has the same intended uses as the predicates.
Basic operation	Air-driven, delivers drive air, cooling air and water, optional fiber optics	Identical	Identical - Fundamental operation is unchanged.
Handpiece/ hose connection	ISO 9168 type 2 or Kavo Multi-Flex compatible (optional)	ISO 9168 type 2 or Kavo Multi-Flex compatible (for Kavo predicate)	Similar/Equivalent - Offers standard connections.
Fiber optics	Solid glass rod (optional)	N/A (for 557T+), Bundled glass fiber (757W), Solid glass rod (Kavo)	Update/Similar - Change from bundled to solid glass rod for some, but within existing tech.
Handpiece head dimensions	Head diam. = 0.410" (10.4mm) / 0.510" (13.0mm); Head length = 0.486" (12.3mm) / 0.583" (14.8mm)	Similar dimensions among all devices (small variations)	Similar - Dimensions are closely comparable to predicates.
Overall handpiece length	4.61"-5.46" (Multi-Flex compatible); 4.75"-5.59" (ISO 9168 Type 2)	Similar lengths among all devices (small variations)	Similar - Lengths are closely comparable to predicates.
Type of chuck	Friction grip Push-button	Friction grip Wrench type / Friction grip Push-button	Similar/Improved - Push-button is present on some predicates, an improvement from wrench-type on one.
Materials used (patient-contact)	Stainless steel	Stainless steel	Identical - Same material.
Materials used (water/air passages)	Stainless steel, polyphenylsulfone (PPSU)	Stainless steel	Similar (with addition) - Adds PPSU, considered in biocompatibility.
Operating pressure	32 - 40 PSI	32 - 40 PSI / 30 - 51 PSI (Kavo)	Similar - Operating pressure range falls within predicate ranges.
Free-running speed	450-510 KRPM / 340-400 KRPM	450-510 KRPM / 340-400 KRPM / 370 KRPM (Kavo)	Similar - Speed ranges are comparable to predicates.
Compliance Standards	Complies with ISO 14457	Complies with ISO 7785-1, ISO 7405, ISO 9168	Updated Standard Compliance - Complies with newer, relevant ISO standard.

Study Proving Device Meets Acceptance Criteria:

The study presented is a nonclinical performance test to demonstrate compliance with the ISO 14457: 2012 standard for air-driven high-speed dental handpieces.

Acceptance Criteria for this study: The device must pass "all the applicable tests of ISO 14457: 2012." The specific tests within ISO 14457:2012 are the de facto acceptance criteria. The document states that the device "passed all the applicable tests."

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

Test Set Sample Size: "master device samples of the Lares Research 557 and 757 ProStyle model product family of high-speed handpieces." This typically means a small number of physical units (e.g., 1-3 of each model) used for testing to the standard. It is not a statistically powered clinical trial sample size.
Data Provenance: The tests were conducted on the manufactured samples of the new device. This is a prospective test specifically for this premarket notification. The document does not specify a country of origin for the testing, but the manufacturer is US-based (Chico, California).

3. Number of Experts Used to Establish Ground Truth and Qualifications:

N/A. For this type of device (dental handpiece) and the nonclinical performance testing, the "ground truth" is adherence to the technical specifications and performance requirements outlined in the ISO 14457: 2012 standard. This is determined by engineering measurements and performance tests, not by expert consensus on, for example, image interpretation. There were no human experts involved in establishing a "ground truth" related to diagnostic accuracy.

4. Adjudication Method for the Test Set:

N/A. There was no adjudication method in the sense of reconciling differences in expert opinions, as the assessment was based on objective physical measurements and adherence to technical standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. An MRMC study is not applicable to a high-speed dental handpiece. This type of study is used for diagnostic devices, particularly those involving human interpretation of data (e.g., radiologists reviewing images) to assess the impact of an AI tool on human performance.

6. Standalone Performance Study:

Yes, implicitly. The nonclinical tests conducted in accordance with ISO 14457: 2012 represent a standalone performance evaluation of the device itself, without human-in-the-loop, against established engineering and safety standards for dental handpieces.

7. Type of Ground Truth Used:

Engineering and Safety Standards / Technical Specifications: The ground truth for this device's performance evaluation against the ISO standard is derived from objective physical measurements and compliance with the defined limits and test methods specified in ISO 14457: 2012. For biocompatibility, the ground truth would be established by relevant ISO standards (e.g., ISO 10993 series), and for sterilization, by validated methods specific to sterilization.

8. Sample Size for the Training Set:

N/A. This device does not involve machine learning or AI that requires a "training set."

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

N/A. As there is no training set, this is not applicable.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October28, 2014

Lares Research Mr. Jason Orgain Engineering Manager 295 Lockheed Avenue Chico, California 95973

Re: K141221

Trade/Device Name: Lares Research 557 and 757 ProStyle model product family of highspeed handpieces Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: September 26, 2014 Received: October 6, 2014

Dear Mr. Orgain:

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 - Mr. Orgain

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K141221

Device Name

Lares Research 557 and 757 ProStyle model product family of high-speed handpieces

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Submitter

Lares Research 295 Lockheed Ave Chico. Ca 95973

Contact person: Telephone: Date prepared:

Trade Names:

Common Name:

Classification Name:

Requlation Number:

Classification Code:

Device Name

Lares Research 557 and 757 ProStyle model product family of high-speed handpieces High-speed Dental Handpiece High-speed Dental Handpiece 21 CFR 872.4200

Predicate Devices

Predicate Device #1:

Predicate Device #2:

Predicate Device #3:

Kavo GENTLEforce 6000B. K073478

Lares Research 557 Turbo+, K780038

Lares Research 757 Workhorse,

Device Description

K905541

Indications for Use

The Lares Research 557 and 757 ProStyle model product family of high-speed handpieces is intended to be used by licensed dental professionals to reduce

807.92(a)(4)

807.92(a)(5)

807.92(a)(1)

807.92(a)(2)

227-226-V-A

807.92(a)(3)

EFB

Jason Orgain

May 7, 2014

530-345-1767 ext 2860

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hard tooth structure, carry out cavity preparations and perform restorative dentistry.

Device Technological Characteristics

807.92(a)(6)

Lares Research 557 ProStyle and 757 ProStyle model product family of highspeed handpieces have ISO 9168 Type 2 connections identical to the 557 Turbo+ and 757 Workhorse, or optional Kavo Multi-Flex compatible connections equivalent to the Kavo GENTLEforce 6000B. The Lares Research 557 and 757 Pro-Style model product family of high-speed handpieces have a maximum input air and cooling fluid pressure of 40 PSI, similar to the Kavo GENTLEforce 6000B. The Lares Research 557 and 757 ProStyle model product family of high-speed handpieces also have push button chuck operation and have optional fiber optics for lighted operation equivalent to the 757 Workhorse. Cooling fluid and atomizing spray connections are integral to the Lares Research 557 and 757 ProStyle model product family of high-speed handpieces similar to all the predicate devices. Materials used in the construction of the Lares Research 557 ProStyle and 757 ProStyle model product family of high-speed handpieces include a stainless steel exterior and stainless steel and polymer interior (see Summary Table of Technological Characteristics).

Summary Table of Technological Characteristics
Product Characteristic	Lares 557 ProStyle	Lares 757ProStyle	Lares 557Turbo+(K780038)	Lares 757Workhorse(K905541)	Kavo 6000B(K073478)
Indications for use	The Lares Research 557 and757 ProStyle model productfamily of high-speedhandpieces is intended to beused by licensed dentalprofessionals to reduce hardtooth structure, carry out cavitypreparations and performrestorative dentistry.	Identical	Equivalent	Equivalent	Equivalent
Basic operation	The handpiece is connected toa dental tubing which deliversdrive air, cooling air and waterto the cutting bur area. Optionalfiber optics deliver light to thecutting area.	Identical	Identical	Identical	Identical
Handpiece/ hoseconnection	ISO 9168 type 2 or Kavo Multi-Flex compatible (optional)	ISO 9168 type 2or Kavo Multi-Flex compatible(optional)	ISO 9168 type2	ISO 9168 type2	Kavo Multi-Flex
Fiber optics	Solid glass rod (optional)	Solid glass rod(optional)	N/A	Bundled glassfiber (optional)	Solid glassrod (optional)
Handpiece headdimensions	Head diam. = 0.410" (10.4mm)Head length =0.486" (12.3mm)	Head diam. =0.510" (13.0mm)Head length=0.583" (14.8mm)	Head diam. =0.400"(10.2mm)Head length=0.486"(14.8mm)	Head diam. =0.510"(13.0mm)Head length=0.583"(14.8mm)	Head diam. =0.493"(12.5mm)Head length=0.516"(13.1mm)

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Overall handpiece length	4.61" (117.1mm) - Multi-Flexcompatible; 5.46" (138.7mm) -ISO 9168 Type 2 connection	4.75" (120.7mm)- Multi-Flexcompatible; 5.59"(142.0/mm) - ISO9168 Type 2connection	5.50"(139.7/mm) -ISO 9168 Type2 connection	5.60"(142.2/mm) -ISO 9168 Type2 connection	4.67"(118.6mm)Multi-Flexconnection
Type of chuck	Friction grip Push-button	Friction gripPush-button	Friction gripWrench type	Friction gripPush-button	Friction gripPush-button
Materials used in patient-contact surfaces (external)	Stainless steel	Stainless steel	Stainless steel	Stainless steel	Informationnot available
Materials used in the waterand air passages (internal)	Stainless steel,polyphenylsulfone (PPSU)	Stainless steel,polyphenylsulfone(PPSU)	Stainless steel	Stainless steel	Informationnot available
Operating pressure	32 - 40 PSI	32 - 40 PSI	32 - 40 PSI	32 - 40 PSI	30 - 51 PSI,40 PSIrecommended
Free-running speed	450-510 KRPM	340-400 KRPM	450-510 KRPM	340-400 kRPM	370 KRPM
Compliance Standards	Complies with ISO 14457	Complies withISO 14457	Complies withISO 7785-1	Complies withISO 7785-1	Complies withISO 7785-1,ISO 7405,ISO 9168

Nonclinical Tests Discussion

Nonclinical tests included:

Performance tests in accordance to international standards ISO 14457: 2012 for air-driven high-speed dental handpieces have been conducted to determine conformance to the standards for the intended use. Biocompatibility and Sterilization studies have been completed using master device samples of the Lares Research 557 and 757 ProStyle model product family of high-speed handpieces. The master device sample Lares Research 557 and 757 ProStyle model high-speed handpiece passed all the applicable tests of ISO 14457: 2012.

Clinical Test Discussion

No clinical field trials have been conducted with the Lares Research 557 and 757 ProStyle model product family of high-speed handpieces.

Data from predicate device post market surveillance. MDR's. MAUDE, and internal Lares Research product complaint data was reviewed to identify potential safety and effectiveness issues that would need to be addressed. No additional issues were identified and the Risk Assessment report for the Lares Research 557 and 757 ProStyle model product family of high-speed handpieces is a record of this review.

Conclusion

The Lares Research 557 and 757 Pro-Style model product family of high-speed handpieces has an equivalent intended use and identical operation as well as substantially similar technological specifications as the predicate devices (Lares Research and Kavo 6000B high-speed handpiece products). The feature

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807.92(b)(3)

807.92(b)(2)

807.92(b)(1)

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updates incorporated into the Lares Research 557 and 757 ProStyle model product family of high-speed handpieces were made to change the material of the fiber optic elements of the handpiece. Data from biocompatibility evaluations. sterilization testing and field experience of predicate devices indicate the Lares Research 557 and 757 ProStyle model product family of high-speed handpieces pose no additional risks.

Based on the device technological characteristics comparison, nonclinical tests discussion, clinical test discussion and specification comparison the Lares Research 557 and 757 ProStyle model product family of high-speed handpieces is substantially equivalent to the 557 Turbo+, 757 Workhorse and Kavo 6000B handpieces.

Guidance document used:

www.fda.gov./.../ucm142651.htm - Content of a 510(k); 510(k) Summary section. This document was used to establish the content for this section.

Format for Traditional and Abbreviated 510(K)s

This guidance document provides a process to determine which type of 510(k) submission best suits this product, and the format of the premarket 510(k) document. Based on the information provided, Lares Research determined the Abbreviated 510(k) would be best suited. Specific recommended forms and section headers indicated in this guidance document were used to create the basic formatting for the Lares Research 557 and 757 ProStyle model product family of high-speed handpieces 510(k) document. Any guidance document listed as a reference for further information in each section was also reviewed and included in this premarket 510(k) document as needed.

Bundling Multiple Devices or Multiple Indications in a Single Submission

This quidance document was used to determine if the Lares Research 557 and 757 ProStyle model product family of high-speed handpieces could be bundled into a single premarket notification. Based on the discussion in Section B of this guidance document, it was decided that the Lares Research 557 and 757 ProStyle model product family of high-speed handpieces has equivalent indications for use and substantially equivalent performance and technological characteristics, which would allow all Lares Research 557 and 757 ProStvle model product family of high-speed handpieces to be bundled into one 510(k) premarket notification.

Dental Handpieces - Premarket Notification [510(k)] Submissions

This guidance document provided specific dental product references for formatting and for information to be included in each section of the 510(k) document. This document also provided a list of standards which are recognized by the FDA for this product code. Specific performance and construction information recommended in this guidance document was also included in the 510(k) premarket notification document.

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The New 510(k) Paradigm, Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications.

This guidance document was used to structure the data supporting substantial equivalence between existing legally marketed products and Lares Research 557 and 757 ProStyle model product family of high-speed handpieces.

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.