(45 days)
Not Found
No
The description focuses on electronic and pneumatic control systems for a dental handpiece, with no mention of AI or ML technologies.
No
The device is described as a hand-held device for dental drilling applications, cutting, finishing, and teeth cleaning/polishing, which are mechanical functions for preparing teeth rather than directly treating or curing a disease.
No
The device is described as a dental handpiece system intended for dental drilling applications such as cutting teeth for caries, crown preparation, finishing, and root canal preparation, as well as teeth cleaning and surface polishing. These are all therapeutic or procedural actions, not diagnostic ones.
No
The device description explicitly states that the system consists of hardware components: a dental handpiece, an electric motor, and a control system housed in a console. It is not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for dental drilling, cutting, finishing, and polishing applications. These are mechanical procedures performed directly on the patient's teeth and surrounding structures.
- Device Description: The description details a dental handpiece system with a motor and control system, designed to drive a dental instrument (like a bur). This aligns with a mechanical tool used in dentistry.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided text makes no mention of analyzing biological specimens.
The device is described as a Class I, non-exempt hand-held device for dental drilling applications, which is consistent with a medical device used for treatment, not diagnosis based on in vitro analysis.
N/A
Intended Use / 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 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 Handpiece 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.
Product codes
EKX
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.
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
dental professionals / general dentistry
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)
No formal performance data was submitted for this Class I device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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 |
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.
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.
1
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™ | Substantial
Equivalence |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Indications for
Use | Indicated for the
preparation of intra-oral
bone for microsurgery and
implantology and for
apicoectomies. The
device is driven by an
electric micromotor or an
air motor handpiece that
has the ISO-3964
Coupling. | 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 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. | Yes |
| Input Voltage | 115V/230V AC 50/60 Hz | 110V/220V AC 50/60 Hz | Yes |
| Materials | Electronic and mechanical
parts and components | Electronic and mechanical parts
and components | Yes |
| Drive Delivery | DC Micromotor with
Controller | DC Micromotor with Controller | Yes |
| Sterilization | Removable Motor Cover
is Autoclavable at 135°C | Removable Motor Cover is
Autoclavable at 135°C | Yes |
| | Bien Air ORL-E-92 | Lares Apex™ | Substantial
Equivalence |
| Indications for
Use | When used in conjunction
with the micromotor and
control indicated above,
the device is intended for
use where high speed is
required in general
dentistry with or without
use of coolant; such as
cutting a tooth for cavity
and/or crown preparation
and finishing, cutting
and/or finishing of
dentures, denture bases,
crowns, inlays and metal
plates. | When used in conjunction with the
micromotor and control indicated
above, the 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. | 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.
6
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
7
INDICATIONS FOR USE
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Apex™ Electric Handpiece System
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 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.
(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)
OR
Over-The-Counter Use:
(Optional Format 1-2-96)