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510(k) Data Aggregation

    K Number
    K220873
    Device Name
    Perceptive electric dental motor and control unit
    Manufacturer
    Lares Research
    Date Cleared
    2022-12-15

    (265 days)

    Product Code
    EIA
    Regulation Number
    872.6640
    Why did this record match?
    Applicant Name (Manufacturer) :

    Lares Research

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended for use in general dentistry and restorative dentists and dental professionals in a dental office.
    Device Description
    The Lares Research Perceptive electrical motor and control is an air-to-electric dental unit for use in dental restoration and prophylaxis procedures. The unit includes a power supply, control unit, user display tablet, hose and a brushless motor. The control unit is programmable to adjust motor speed, motor direction, and light intensity. The inputs to the control unit are supplied by an electronic tablet which is connected to the unit via a USB cable. The electronic tablet Perceptive application accepts both finger touch and a limited set of voice commands. The motor speed can also be controlled via the pneumatic footswitch connected to the control unit. The unit is designed to control the motor to drive ISO 3964 compatible contra angle and straight dental handpieces at an output speed of 1,000 to 40,000 rpm.
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    K Number
    K220874
    Device Name
    Smooth Drive contra angle and straight handpieces
    Manufacturer
    Lares Research
    Date Cleared
    2022-11-07

    (227 days)

    Product Code
    EGS
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    Lares Research

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Products intended for professional use only. Used in general dentistry for restoration procedures.
    Device Description
    The Lares Research Smoothdrive 1:5 contra angle is a high-speed dental handpiece which is driven by an electrical motor. The device is designed to be connected to ISO 3964 compatible electric motors operating between 0 and 40,000 rpm. The device has a 1:5 speed increasing transmission (identified by the industry standard red ring) which translates to a working end speed of 0 to 200,000 rpm. The device has a push button chucking system is designed to allow convenient bur changing for ISO 1797 type 3 burs.
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    K Number
    K141221
    Device Name
    LARES ULTRALITE PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES EURO PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES TURBO+ PR
    Manufacturer
    LARES RESEARCH, INC.
    Date Cleared
    2014-10-28

    (169 days)

    Product Code
    EFB
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    LARES RESEARCH, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended 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.
    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.
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    K Number
    K031540
    Device Name
    APEX ELECTRIC HANDPIECE SYSTEM
    Manufacturer
    LARES RESEARCH, INC.
    Date Cleared
    2003-06-30

    (45 days)

    Product Code
    EKX
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    LARES RESEARCH, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended 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.
    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.
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    K Number
    K011960
    Device Name
    LARES RESEARCH SUNLASE 800P LASER SYSTEM (TO BE SOLD AS POCKETPRO OR POCKETPRO S4)
    Manufacturer
    LARES RESEARCH, INC.
    Date Cleared
    2001-12-21

    (182 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    LARES RESEARCH, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SunLase 800P laser device is to provide the ability to perform intraoral soft tissue dental, general, oral maxillo-facial and cosmetic surgery. The device is indicated for ablating, incising, excising, vaporization and coagulation of soft tissues using a contact, fiber-optic delivery system. The device will be used in the following areas: general and cosmetic dentistry, otolaryngology, oral surgery. The following are the oropharangeal indications for use for which the device will be marketed: - Excisional and incisional biopsies - Excision and vaporization of herpes simplex I and II - Exposure of unerupted teeth - Fibroma removal - Frenectomy and Frenotomy - Gingival troughing for crown impressions - Gingivectomy - Gingivoplasty - Gingival incision and excision - Hemostasis - Implant recovery - Incision and drainage of abscess - Laser Assisted Uvulopaletoplasty (LAUP) - This laser is effective for cutting, ablating, coagulating and removing oropharangeal soft tissue that has been diagnosed as anatomically abnormal or naturally occurring hypertrophic which has been identified and confirmed as being associated with chronic palatal snoring. - Leukoplakia - Operculectomy - Oral Papillectomies - Pulpotomy and Pulpotomy as an adjunct to root canal therapy - Reduction of denture hyperplasia - Reduction of gingival hypertrophy - Reduction of filling material such as gutta percha or resin as adjunct treatment during root canal therapy - Removal of post-surgical granulations - Selective ablation of enamel (First Degree Caries Removal) - Soft tissue crown lengthening - Sulcular debridement or soft tissue curettage (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss, and tooth mobility) - Tissue retraction for impression - Treatment of Apthous ulcers - Vestibuloplasty
    Device Description
    The laser device produces an invisible treatment beam for surgery and a visible aiming beam. The pulsed Nd:YAG treatment beam is an invisible beam of light (1064 nanometer wavelength); a Helium-Neon (HeNe) laser within the laser head console supplies the red aiming beam. The laser energy is developed inside an optical resonant cavity. A crystal rod of neodymium-doped Yttrium Aluminum Garnet (pulsed Nd:YAG) is placed between two mirrors. The rod is "pumped" by a flashlamp that excites the Neodymium ions in the YAG crystal. Once excited, stimulated emission of photons occurs. Laser energy exits the cavity through a partially transmitting mirror and enters the distal end of the contact fiber-optic cable at the aperture. The laser energy is transmitted though the fiber-optic cable and exits the proximal tip of the fiber. The device is controlled by microprocessor via keyboard access by the operator, which allows various settings for energy levels, pulse widths and repetition rates. Software controls preclude emission of laser energy in any of a number of fault conditions.
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    K Number
    K983524
    Device Name
    LARES RESEARCH SUNLASE 800P LASER SYSTEM (TO BE SOLD AS PEIOLASE FOR LASERENAP)
    Manufacturer
    LARES RESEARCH, INC.
    Date Cleared
    1999-04-01

    (175 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    LARES RESEARCH, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SunLase 800P is indicated for incising, excising and coagulating intraoral soft tissue, including the marginal and interdental gingiya. This includes incising, excising and coagulating the epithelium lining, the free or marginal gingiva, sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket).
    Device Description
    Not Found
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    K Number
    K961163
    Device Name
    LARES RESEARCH AS-1 LOWSPEED HANDPIECE
    Manufacturer
    LARES RESEARCH, INC.
    Date Cleared
    1996-04-23

    (32 days)

    Product Code
    EFB
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    LARES RESEARCH, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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