Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML terms or functionalities.

Therapeutic

No
The device is a high-speed dental handpiece used for physical operations like reducing tooth structure and preparing cavities, rather than for directly treating or curing a disease or condition.

Diagnostic

No
The device is described as a high-speed dental handpiece used for reducing hard tooth structure, preparing cavities, and performing restorative dentistry, which are treatment-oriented functions, not diagnostic ones.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical, air-driven dental handpiece, which is a hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to "reduce hard tooth structure, carry out cavity preparations and perform restorative dentistry." This is a direct surgical/procedural intervention on the patient's body, not a test performed on a sample taken from the body.
Device Description: The device is described as an "air-driven high-speed turbine dental drill." This is a tool used for mechanical manipulation of tissue, not for analyzing biological samples.
Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (like blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This dental handpiece does not fit that definition.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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

Product codes (comma separated list FDA assigned to the subject device)

EFB

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Hard tooth structure

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Licensed dental professionals

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)

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.

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.

Kavo GENTLEforce 6000B. K073478, Lares Research 557 Turbo+, K780038, Lares Research 757 Workhorse, K905541

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

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.

Summary

0

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a human face in profile, with three overlapping profiles to represent the department's focus on health, human services, and the well-being of the nation. The seal is black and white.

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.

1

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

2

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)

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.

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)

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:

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3

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

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.

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

4

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 757
ProStyle	Lares 557
Turbo+
(K780038)	Lares 757
Workhorse
(K905541)	Kavo 6000B
(K073478)
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 hard
tooth structure, carry out cavity
preparations and perform
restorative dentistry.	Identical	Equivalent	Equivalent	Equivalent
Basic operation	The handpiece is connected to
a dental tubing which delivers
drive air, cooling air and water
to the cutting bur area. Optional
fiber optics deliver light to the
cutting area.	Identical	Identical	Identical	Identical
Handpiece/ hose
connection	ISO 9168 type 2 or Kavo Multi-
Flex compatible (optional)	ISO 9168 type 2
or Kavo Multi-
Flex compatible
(optional)	ISO 9168 type
2	ISO 9168 type
2	Kavo Multi-
Flex
Fiber optics	Solid glass rod (optional)	Solid glass rod
(optional)	N/A	Bundled glass
fiber (optional)	Solid glass
rod (optional)
Handpiece head
dimensions	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)

5

| Overall handpiece length | 4.61" (117.1mm) - Multi-Flex
compatible; 5.46" (138.7mm) -
ISO 9168 Type 2 connection | 4.75" (120.7mm)

Multi-Flex
compatible; 5.59"
(142.0/mm) - ISO
9168 Type 2
connection | 5.50"
(139.7/mm) -
ISO 9168 Type
2 connection | 5.60"
(142.2/mm) -
ISO 9168 Type
2 connection | 4.67"
(118.6mm)
Multi-Flex
connection |
|------------------------------------------------------------|---------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|--------------------------------------------------------|--------------------------------------------------------|-------------------------------------------------------|
| Type of chuck | Friction grip Push-button | Friction grip
Push-button | Friction grip
Wrench type | Friction grip
Push-button | Friction grip
Push-button |
| Materials used in patient-
contact surfaces (external) | Stainless steel | Stainless steel | Stainless steel | Stainless steel | Information
not available |
| Materials used in the water
and air passages (internal) | Stainless steel,
polyphenylsulfone (PPSU) | Stainless steel,
polyphenylsulfone
(PPSU) | Stainless steel | Stainless steel | Information
not available |
| Operating pressure | 32 - 40 PSI | 32 - 40 PSI | 32 - 40 PSI | 32 - 40 PSI | 30 - 51 PSI,
40 PSI
recommended |
| Free-running speed | 450-510 KRPM | 340-400 KRPM | 450-510 KRPM | 340-400 kRPM | 370 KRPM |
| Compliance Standards | Complies with ISO 14457 | Complies with
ISO 14457 | Complies with
ISO 7785-1 | Complies with
ISO 7785-1 | Complies with
ISO 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

Page 3 of 5

807.92(b)(3)

807.92(b)(2)

807.92(b)(1)

6

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.

7

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.