The Lares Research Apex™ Electric Handpiece System ("System" defined as and limited to: A. Contra Angle Dental Instrument B. Electric Motor and C. Control System) device consists of a dental handpiece and accessories as listed in 21 CFR 872.4200, product code EKX that is a Class I, non-exempt hand-held device for dental drilling applications. This device is indicated for use where high speeds are required in general dentistry with or without the use of coolant where precision control of the cutting bur is desired such as cutting a tooth for caries, and/or crown preparation and finishing, cutting and/or finishing for dentures, denture bases, crowns, inlays and metal plates and/or root canal preparation for restoration. The device is also indicated for use in difficult to reach areas in general dentistry with or without the use of coolant where precision control of the cutting bur is desired such as the preparing dental caries for restorations, and for use at low speeds in teeth cleaning applications and dental surface polishing. The Apex™ Electric Handbiece System device is driven by an electronically controlled DC electric motor with a pneumatic/electronic actuated control system that is connected to the Contra Angle dental instrument via an ISO-3964 coupling. The Apex™ Electric Handpiece System device is indicated for use by dental professionals only.

Device Description

The Apex™ Electric Handpiece System is a pneumatic/electronic controlled drive for dental drilling applications. The system consists of (3) components: A commercially-available electronic control system and electric motor and, Contra Angle dental instrument.
The Apex™ Electric Handpiece System consists of a console type desktop housing with the electronic microprocessor with integrated electric and pneumatic-electric controls, a high-torque motor sealed against lubrication from handpieces with removable motor sleeve and, Contra Angle dental instrument.
The Apex™ Electric Handpiece System uses a DC controlled micromotor as the driving element of the system, controlled by an electronic microprocessor that is actuated by the practicing dentist's existing air delivery system via foot pedal. Rotation of the dental instrument is controlled by the translation of air to electrical power wherein a wide range of speeds can be achieved and maintained resulting in a precise control of torque and light at the procedure site.

AI/ML Overview

The provided text is a 510(k) summary for a dental handpiece system. It pertains to a device that is classified as Class I (general controls) and specifically states that no formal performance data was submitted. This means the document does not contain information about acceptance criteria or a study proving the device meets them in the way one might expect for a higher-risk device that relies on clinical or in-vitro performance studies.

Instead, the submission relies on demonstrating substantial equivalence to legally marketed predicate devices and adherence to relevant industry standards. The primary "test" described is a biocompatibility/cytotoxicity evaluation.

Here's an analysis based on your requested information, focusing on what is available and explicitly stating what is not available in this specific document:

Acceptance Criteria and Device Performance for Apex™ Electric Handpiece System

Based on the provided 510(k) summary, the primary area where specific "acceptance criteria" and "reported performance" are detailed is regarding biocompatibility/cytotoxicity. For other aspects, the device's acceptability is demonstrated through substantial equivalence to predicate devices and compliance with recognized standards.

1. Table of Acceptance Criteria and Reported Device Performance

Criteria Category	Acceptance Criteria	Reported Device Performance
Biocompatibility - Cytotoxicity	Grade zero (0) = No Cellular Destruction, indicating no cytotoxicity substances were extractable.	Grade zero (0) = No Cellular Destruction was indicated. "The 3 Lares Handpiece samples tested... gave No indication that any cytotoxicity substances were extractable."
Functional Equivalence	Device characteristics (e.g., indications for use, input voltage, materials, drive delivery, sterilization features, speeds, lighting, water spray, bur release, coupler, autoclavability) are substantially equivalent to the predicate devices (Bien Air ORL-E-92 Surgical Drill System, W & H Synea WA-99LT, NSK Speed Increaser Contra Angle).	The comparison tables (Section XII) show "Yes" for Substantial Equivalence across all listed technical characteristics when compared to the Bien Air ORL-E-92 and another Bien Air Contra Angle (though the latter's model number is not explicitly listed at the top of the column, it can be inferred from the context of the comparison). The narrative explicitly states the device is "substantially equivalent" in design, speed, rotation, irrigation, and autoclavability.
Standards Compliance	Meets all applicable ISO, IEC, and FDA Guidance Standards.	"Lares Research, Inc. has taken all steps necessary to assure that the Apex™ Electric Handpiece System meets all applicable ISO, IEC and FDA Guidance Standards listed in Section XV of this document."

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

Test Set Sample Size:
- For the biocompatibility/cytotoxicity evaluation: Three (3) separate Lares Handpiece samples were tested.
- For functional equivalence (comparison to predicate devices) and standards compliance: Not applicable in the same way as a clinical study. The device itself is the "test article" compared against specifications and predicate device characteristics.
Data Provenance:
- Biocompatibility/cytotoxicity evaluation: Conducted by Nelson Laboratories (Salt Lake City, UT). The report is dated June 19, 2003. This is an in vitro test.
- Functional equivalence and standards compliance: Based on internal assessment by Lares Research, Inc. and comparison to publicly available information or specifications of predicate devices and standards. This is not "data provenance" in the clinical study sense.

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

Biocompatibility/Cytotoxicity: The ground truth (assessment of cellular destruction) was established by the Nelson Laboratories personnel conducting the in vitro MEM Elution test. The document does not specify the number or qualifications of these experts beyond stating the lab conducted the evaluation. It's a laboratory test with objective scoring criteria, rather than expert interpretation of complex clinical data.
Functional Equivalence/Standards Compliance: The "ground truth" here is the established specifications of the device and the predicate devices, and the requirements of the standards. The comparison was performed by Lares Research, Inc., as part of their 510(k) submission. No external "experts" were explicitly mentioned for subjective "ground truth" establishment in this context.

4. Adjudication Method for the Test Set

Biocompatibility/Cytotoxicity: The grading of cellular destruction (Grade 0) is based on a standardized and objective laboratory assay (MEM Elution). No explicit "adjudication method" (like 2+1 or 3+1 for expert review) is mentioned or likely relevant for this type of in vitro test. The result is a direct observation and scoring based on the test protocol.
Other aspects: Not applicable as there isn't a "test set" requiring adjudication in the context of clinical or image-based studies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improve with AI vs. Without AI Assistance

No, an MRMC comparative effectiveness study was not done. This document pertains to a dental handpiece (a mechanical device), not an AI or imaging diagnostic tool. Therefore, discussions of human reader improvement with AI assistance are irrelevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, performance of an algorithm (standalone or otherwise) was not done. This document is for a physical dental handpiece system, not a software algorithm.

7. The Type of Ground Truth Used

Biocompatibility/Cytotoxicity: Objective laboratory measurements/observations of cellular destruction in an in vitro MEM Elution test, scored based on established criteria for such assays.
Functional Equivalence: Comparison against predicate device technical specifications and performance characteristics and recognized industry standards.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" for this type of device submission. The device is a mechanical tool, not a machine learning model.

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

Not applicable. As there is no training set, there is no ground truth for it.

Summary:

This 510(k) submission for the Apex™ Electric Handpiece System primarily relies on demonstrating:

Biocompatibility through a specific in vitro cytotoxicity test on 3 samples, which showed no cellular destruction.
Substantial Equivalence to existing legally marketed predicate devices by comparing technical characteristics (design, speed, control, sterilization, etc.).
Compliance with recognized industry standards (ISO, IEC, FDA Guidance Standards).

The document explicitly states that "No formal performance data was submitted for this Class I device." This is typical for Class I devices where safety and effectiveness are largely demonstrated through adherence to general controls, standards, and substantial equivalence to market predecessors, rather than extensive clinical performance trials.

Summary

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June 23, 2003 Revised -Safety and Effectiveness and of Summary of Performance Data and Cytotoxicity Data Review for the Apex™ Electric Handpiece System - Original 510(k)

K031540

Premarket Notification, Lares® Research, Inc.

This 510(k) summary of safety and effectiveness information was submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

I. Submitted By:	Lares Research, Inc.
	295 Lockheed Avenue
	Chico, CA 95973 USA
	Contact: John Dahlgren
	Telephone: 530-345-1767 x262
	Fax: 530-345-1870
	E-Mail: jdahlgren@laresdental.com

II. Date: 510(k) prepared April 6, 2003

III. 510(k) Reason: Marketing and commercial distribution of this device for the first time.

IV. Trade Name: Apex™ Electric Handpiece System

V. Classification Name: Dental Handpiece and Accessories (21 CFR 872.4200)

VI. Classification: The device is a general control of Class I according to 21CFR 872.4200

VII. The Apex™ Device Description and List of Predicate Devices

Company	Device	510(k) No.	Date Cleared
Bien Air USA, Inc.	ORL-E-92 Surgical Drill System	K984244	02/23/1999
W & H	Synea WA-99LT	K993526	01/11/2000
NSK	Speed Increaser Contra Angle	K972569	10/08/1997

VIII. Biocompatibility/Cytotoxicity Data Evaluation: Nelson Laboratories (Salt Lake City, UT) was contracted to carry out a biocompatibility-cytotoxicty evaluation of this Lares Research Apex™ Electric Handpiece System after treatment with the Lares Handpiece Conditioner (with lubricant and solvent). Nelson Labs performed a Minimum Essential Medium (MEM) Elution on three (3) separate Lares Handpiece samples [See Appendix #3: Nelson Laboratories MEM Elution [and Cytotoxicty Evaluation] Method and Appendix #4: Nelson Laboratories MEM Elution ~ Final Report for the Lares Research Apex 200LS Contra-Angle Electric Handpiece Instrument] beginning June 13 and ending June 19, 2003.

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This type of testing was designed to evaluate the cytotoxicty of any extractable substances or residues associated with the 3 Lares Handpiece samples immediate after the described treatment protocol with the separately sold Lares Research Conditioner [with lubricant and solvent]. The extract of the samples was added to cell line monolayers (Mouse Heteroploid Connective Tissue L-929), and the extract and confluent monolayers incubated at 37°C with 5 +/-1% CO2 for 48 +/- 3 hrs. Cell monolavers were examined microscopically, and scored on the basis of the degree of cellular death and/or damage. Pages 5 - 8 of the attached Nelson Laboratories MEM Elution -Final Report [dated 6-19-03] for the Lares Research Apex 200LS Contra-Angle Electric Handpiece Instrument has provided results demonstration grade zero (0) = No Cellular Destruction was indicated. The 3 Lares Handpiece samples tested, even after the described treatment protocol with the separately sold Lares Research Device Conditioner [with Jubricant and solvent], qave No indication that any cytotoxicity substances were extractable [page 8 of the Nelson report of 6/19/03). Thus the Lares Handpiece Conditioner was deemed to be biocompatible for use with these Handpieces.

IX. Indications for Use: The Lares Research Apex™ Electric Handpiece System ("System" defined as and limited to: A. Contra Angle Dental Instrument B. Electric Motor and C. Control System) device consists of a dental handpiece and accessories as listed in 21 CFR 872.4200, product code EKX that is a Class I, non-exempt hand-held device for dental drilling applications. This device is indicated for use where high speeds are required in general dentistry with or without the use of coolant where precision control of the cutting bur is desired such as cutting a tooth for caries, and/or crown preparation and finishing, cutting for dentures, denture bases, crowns, inlays and metal plates and/or root canal preparation for restoration. The Apex™ Electric Handpiece System device is also indicated for use in difficult to reach areas in general dentistry with or without the use of coolant where precision control of the cutting bur is desired such as the preparing dental caries for restorations, and for use at low speeds in teeth cleaning applications and dental surface polishing. The Apex™ Electric Handpiece System device is driven by an electronically controlled DC electric motor with a pneumaticlelectronic actuated control system that is connected to the Contra Angle dental instrument via an ISO-3964 coupling. The Apex™ Electric Handpiece System device is indicated for use by dental professionals only.

X. Technical Characteristics: The Apex™ Electric Handpiece System consists of a console type desktop housing with the electronic microprocessor with integrated electric and pneumatic-electric controls, a high-torque motor sealed against lubrication from handpieces with removable motor sleeve and, Contra Angle dental instrument.

The Apex™ Electric Handpiece System uses a DC controlled micromotor as the driving element of the system, controlled by an electronic microprocessor that is actuated by the practicing dentist's existing air delivery system via foot pedal. Rotation of the dental instrument is controlled by the translation of air to electrical power wherein a wide range of speeds can be achieved and maintained resulting in a precise control of torque and light at the procedure site.

XI. Principle of Operation: The three components of the Apex™ Electric Handpiece System work in unison to deliver precise torque, speed and light at the procedure site. The principle of operation is as follows:

Apex™ Control System: The Apex™ Control System connects to an existing air unit allowing the use of the Apex™ Electric Motor. Connection of the Apex™ Control System is accomplished via existing four-hole tubing from air supply. The air pressure is reduced to accommodate proper connection of the control. The Control System is then plugged into an existing 110V electrical outlet.

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Apex™ Electric Motor: The output tubing from the Apex™ Control System is located and connected to the Apex™ Electric Motor. When connected, the existing air supply foot pedal is depressed and the air pressure is increased to operating levels while the electric motor is running.

Apex™ Contra Angle Dental Instrument: The Apex™ Contra Angle Dental Instrument is connected to the Apex™ Electric Motor via an ISO 3964 coupler. The Apex™ Electric Handpiece System is now ready for use. The dental professional then mounts the bur of choice for the procedure.

At this time, the operator then selects an appropriate speed via the Apex™ Control System control panel labeled "Motor Speed". Rotation direction can be set at the Apex™ Control System control panel to either "forward" or "reverse". Once desired speed and proper rotation initiated, the operator can proceed with the dental procedure accordingly.

	Bien Air ORL-E-92	Lares Apex™	SubstantialEquivalence
Indications forUse	Indicated for thepreparation of intra-oralbone for microsurgery andimplantology and forapicoectomies. Thedevice is driven by anelectric micromotor or anair motor handpiece thathas the ISO-3964Coupling.	Indicated for use where highspeeds are required in generaldentistry with or without the use ofcoolant where precision control ofthe cutting bur is desired such ascutting a tooth for caries, and/orcrown preparation and finishing,cutting and/or finishing fordentures, denture bases, crowns,inlays and metal plates and/or rootcanal preparation for restoration.The device is driven by anelectronically controlled DC electricmotor with a pneumatic/electronicactuated control system that isconnected to the Contra Angledental instrument via an ISO-3964coupling.	Yes
Input Voltage	115V/230V AC 50/60 Hz	110V/220V AC 50/60 Hz	Yes
Materials	Electronic and mechanicalparts and components	Electronic and mechanical partsand components	Yes
Drive Delivery	DC Micromotor withController	DC Micromotor with Controller	Yes
Sterilization	Removable Motor Coveris Autoclavable at 135°C	Removable Motor Cover isAutoclavable at 135°C	Yes
	Bien Air ORL-E-92	Lares Apex™	SubstantialEquivalence
Indications forUse	When used in conjunctionwith the micromotor andcontrol indicated above,the device is intended foruse where high speed isrequired in generaldentistry with or withoutuse of coolant; such ascutting a tooth for cavityand/or crown preparationand finishing, cuttingand/or finishing ofdentures, denture bases,crowns, inlays and metalplates.	When used in conjunction with themicromotor and control indicatedabove, the device is indicated foruse where high speeds arerequired in general dentistry withor without the use of coolant whereprecision control of the cutting buris desired such as cutting a toothfor caries, and/or crownpreparation and finishing, cuttingand/or finishing for dentures,denture bases, crowns, inlays andmetal plates and/or root canalpreparation for restoration. Thedevice is also indicated for use indifficult to reach areas in generaldentistry with or without the use ofcoolant where precision control ofthe cutting bur is desired such asthe preparing dental caries forrestorations, and for use at lowspeeds in teeth cleaningapplications and dental surfacepolishing.	Yes
Speeds	Bien Air CA 1541 1:5 0-200K	Apex™ 200LS 1:5 0-200K	Yes
	Bien Air CA 1142 1:1 0-40K	Apex™ 40LS 1:1 0-40K	Yes
	Bien Air CA 10141 10:1 0-4K	Apex™ 10LS 5:1 0-7K	Yes
Lighting	Yes	Yes	Yes
Water Spray	Yes-Triple Port	Yes-Triple Port	Yes
Bur Release	Push Button	Push Button	Yes
Coupler	ISO 3964 Compatible	ISO 3964 Compatible	Yes
Sterilization	135°C Autoclavable	135°C Autoclavable	Yes

XII. Substantial Equivalence Comparison - Micromotor and Control:

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XII. Substantial Equivalence Comparison ~ Contra Angle:

The Lares Research Apex™ Electric Handpiece System device is substantially equivalent to the Bien Air ORL-E-92 Surgical Drill System in commercial distribution by Bien Air USA, Inc. The fundamental technical characteristics of the Apex™ Electric Handpiece System are similar to those of the predicate devices, principally the Bien Air ORL-E-92 Surgical Drill System. The Apex™ Electric Handpiece System is equivalent to the Bien Air ORL-E-92 Surgical Drill System in design, speed, rotation, irrigation and autoclavability. Both Apex™ Electric Handpiece System and Bien Air ORL-E-92 Surgical Drill System use an electric micromotor, parts of which are autoclavable and an electronic control for speed regulation and direction. The range of speed of this device is equivalent to predicate devices and both systems use contra angled handpieces.

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XIII. Performance Data: No formal performance data was submitted for this Class I device. Lares Research, Inc. has taken all steps necessary to assure that the Apex™ Electric Handpiece System meets all applicable ISO, IEC and FDA Guidance Standards listed in Section XV of this document and all data supporting this statement is available at Lares Research for review by any authorized agents of the Food and Drug Administration (FDA).

XIV. 510(k) Checklist: This notification contains all information required by 21 CFR 807.87

XV. Applicable Standards:

Guidance Documents:

Guidance Document on Dental Handpieces, issued July 1995 via the Internet at: http://www.fda.gov/cdrh/ode/556.pdf

Dental Handpiece Sterilization as issued September, 1992 via the Internet at: http://www.fda.gov/cdrh/comp/589.pdf

Device Safety:

IEC 601-1, IEC 601-1-2, IEC-IA (as equivalent and fully corresponding to the European standards EN 60601-1, EN 60601-1-2, EN 60601-14)

EMC Compatibility:

IEC 601-1-2 with reference to EN 55011, EN 610004-2, EN 610004-3, EN 6100044, EN 610004-5: conformity has been certified during an independent examination by a competent bodv.

Dental Handpieces:

ISO 3964 Dental Handpieces - Coupling Dimensions

ISO 7785-2 Dental Handpieces - Part 2: Straight and geared angle handpieces

ISO 9687 Dental Equipment - Graphical Symbols

ISO 11498.1 Dental Handpieces - Dental Low Voltage Electrical Motors

XVI. 510(k) Contact Person:

For further information, please contact:

John Dahlgren, Director of Regulatory Affairs Lares Research, Inc., 295 Lockheed Avenue, Chico, CA 95973 USA Telephone: 530-345-1767 x262; Fax: 530-345-1870 E-Mail: jdahlgren@laresdental.com

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Image /page/5/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a symbol consisting of three stylized human profiles facing to the right, with flowing lines beneath them that could represent water or movement. The overall design is simple and conveys a sense of unity and service.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 3 0 2003

Lares Research, Incorporated C/O Mr. Alfredo J. Quattrone Responsible Third Party Official California Department of Health Services Food & Drug Branch P.O. Box 942732 (MS-357) Sacramento, California 94234-7320

Re: K031540

Trade/Device Name: Apex™ Electric Handpiece System Regulation Number: 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EKX Dated: June 23, 2003 Received: June 24, 2003

Dear Mr. Quattrone:

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.

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Page 2 - Mr. Quattrone

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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation 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) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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), please contact the Office of Compliance at (301) 594-4613. 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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Susan Turner

Susan Runner, DDS, MA Interim 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

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Apex™ Electric Handpiece System

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Ken Mely for VSR

(Division Sian-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K031546

Prescription Use:
(Per 21 CFR 801.109)

Over-The-Counter Use:

(Optional Format 1-2-96)

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.