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510(k) Data Aggregation

    K Number
    K093341
    Device Name
    CENTURY MODEL 105C
    Manufacturer
    SYBRON DENTAL SPECIALTIES, INC.
    Date Cleared
    2010-04-05

    (164 days)

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

    SYBRON DENTAL SPECIALTIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Century 105C Handpieces are intended for the removal of carious material, cavities and crown preparations, removal of fillings, and processing of tooth and restoration surfaces. They are designed for use by a trained professional in the field of general dentistry.
    Device Description
    The Century 105C Handpieces are dental instruments for use by a trained professional in general dentistry. The handpieces are powered by pneumatic pressure on a rotor with roller bearings. The devices are re-usable and ergonomically shaped, and can be sterilized by the steam autoclave method.
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    K Number
    K091091
    Device Name
    SONICFILL 2010
    Manufacturer
    SYBRON DENTAL SPECIALTIES, INC.
    Date Cleared
    2009-10-14

    (181 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Why did this record match?
    Applicant Name (Manufacturer) :

    SYBRON DENTAL SPECIALTIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SONICFill 2010 is a dental delivery system intended to be used to dispense Metamorphosis, a dental restorative resin, directly into dental cavities.
    Device Description
    The SONICFill 2010 is an air driven dental delivery system intended to dispense Metamorphosis, a dental restorative resin, directly into dental cavities. The device allows fast and easy extrusion of the composite, which is held in single-dose cartridges (tips). The tips are connected to the device via a screw thread. The device is attached to the dental unit through a coupling and a hose. It is powered via compressed air supplied by the operative unit. The device is switched on and off through the footswitch of the dental unit and the power output can be adjusted through a regulating ring located on the device. The devices can be sterilized by the steam autoclave method.
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    K Number
    K080089
    Device Name
    SONICFLEX 2003 AND SONICFLEX LUX 2003 L WITH INSTRUMENT TIPS
    Manufacturer
    SYBRON DENTAL SPECIALTIES, INC.
    Date Cleared
    2008-09-04

    (234 days)

    Product Code
    ELC
    Regulation Number
    872.4850
    Why did this record match?
    Applicant Name (Manufacturer) :

    SYBRON DENTAL SPECIALTIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SONICflex 2003 and SONICflex Lux 2003 L with Instrument Tips are air-powered scalers intended for use in following areas: - · Tooth scaling and cleaning · Scaling: - · Tooth neck and subgingival treatment - · Root planning - · Initial therapy - · Implant maintenance - · Canal preparation and cleaning - · Micro retro surgery - · Inlay / onlay condensation - · Fissure cleaning - · Minimal invasive cavity cleaning - · Endodonties: · Periodontics: - · Prosthesis: The SONICflex 2003 and SONICflex Lux 2003 L with Instrument Tips are air-powered scalers for use by qualified dental practitioners in the four conventional dental applications of scaling, periodontics, endodontics and prosthesis.
    Device Description
    The SONICHex 2003 / SONICJlex Lux 2003 L. & Instrument Tips consist of a handpiece, instrument tips, quick-action coupling and accessories for changing and cleaning the instrument tips. The handpieces are attached over a coupling and a hose to a dental operative unit. The power delivered to the handpiece is adjusted via a control ring located on the handpiece. The only difference between the SONICflex 2003 and the SONICJlex Lux 2003 L scaler is that the SONICflex Lux 2003 1. has an integrated fiber optic. A variety of tips are available for specific dental applications and for reaching different areas of the mouth. The devices can be sterilized by the steam autoclave method.
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    K Number
    K073478
    Device Name
    SUPERTORQUE HIGH-SPEED HANDPIECES AND GENTLEPOWER HANDPIECES AND ATTACHEMENTS
    Manufacturer
    SYBRON DENTAL SPECIALTIES, INC.
    Date Cleared
    2008-09-03

    (267 days)

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

    SYBRON DENTAL SPECIALTIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SUPERtorque High-Speed Handpieces are intended for the removal of carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations, restorations, and for polishing teeth. They are designed for use by a trained professional in the field of general dentistry. The GENTLEpower Handpieces and Attachments are intended for the removal of carious material, excess filling material, reducing hard tooth structure, cavity and crown preparation, root canal preparation, finishing tooth preparations, restorations and for polishing teeth. They are designed for use by a trained professional in the field of general dentistry.
    Device Description
    The SUPERtorque High-Speed Handpieces are dental handpieces for use by a trained professional in general dentistry. The devices are air-powered handpieces that are reusable and ergonomically shaped, and are provided both with and without a fiber optic light system. The devices can be sterilized by the steam autoclave method. The GENTLEpower Handpieces and Attachments are dental instruments for use by a trained professional in general dentistry. The handpieces and attachments are powered by either an air-motor or electric motor. The devices are re-usable and ergonomically shaped, and can be sterilized by the steam autoclave method.
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    K Number
    K071615
    Device Name
    FIXAFLOSS
    Manufacturer
    SYBRON DENTAL SPECIALTIES, INC.
    Date Cleared
    2007-09-21

    (100 days)

    Product Code
    EEF
    Regulation Number
    872.6300
    Why did this record match?
    Applicant Name (Manufacturer) :

    SYBRON DENTAL SPECIALTIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the FixaFloss is to be placed between teeth for the fixation of rubber dams. The FixaFloss is a waxed dental floss with a silicone conical clamping element intended to be placed between teeth for rubber dam fixation.
    Device Description
    The FixaFloss is a waxed dental floss assembled with 1 size and 1 color silicone conical resilient clamping element packaged as a one string product containing 20 resilient connes in a hygienic dispenser with an integrated cutting blade.
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    K Number
    K071288
    Device Name
    MODIFICATION TO KAVO QUATTROCARE
    Manufacturer
    SYBRON DENTAL SPECIALTIES, INC.
    Date Cleared
    2007-07-19

    (72 days)

    Product Code
    EBF, EFB
    Regulation Number
    872.3690
    Why did this record match?
    Applicant Name (Manufacturer) :

    SYBRON DENTAL SPECIALTIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    KaVo QUATTROcare is a unit intended for internal cleaning, i.e, purging of old lubricant, for the maintenance of rotating dental and surgical instruments. The KaVo QUATTROcare spray can is a component of the KaVo QUATTROcare unit and is specifically designed to fit this unit only. The lubricant spray can is unable to be used manually. NOTE: The Kallo QUATTROcare should be used with only pre-cleaned dental handpieces and before they are sterilized.
    Device Description
    The KaVo QUATTROcare Modified is a unit that uses an aerosol product based upon hydrocarbon propellants with a lubricant for use in the routine maintenance (cleaning and lubrication) of dental handpieces prior to sterilization. The lubricant is housed within a spray can and is a component of the unit. The KaVo QUATTROcare Modified device was modified to enhance the secure fit of the lubricant spray can to the unit through the utilization of two independent sealing systems - the screw can sealing and an additional O-ring sealing in the connector.
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    K Number
    K070327
    Device Name
    REMOVABLE ARYLIC HERBST, ALLESEE SNORE APPLIANCE (ASA), AND ENOCH SNORINATOR
    Manufacturer
    SYBRON DENTAL SPECIALTIES, INC.
    Date Cleared
    2007-05-25

    (109 days)

    Product Code
    LRK
    Regulation Number
    872.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    SYBRON DENTAL SPECIALTIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Removable Acrylic Herbst is intended to be used for the reduction of snoring and mild to moderate obstructive sleep apnea (OSA) by repositioning the lower jaw into a prescribed relationship to the upper jaw. The Allesee Snore Appliance (ASA) is intended to be used for the reduction of snoring and mild to moderate obstructive sleep apnea (OSA) by repositioning the lower jaw into a prescribed relationship to the upper jaw. The Enoch Snorinator is intended to be used for the reduction of snoring and mild to modcrate obstructive sleep apnea (OSA) by repositioning the lower jaw into a prescribed relationship to the upper jaw.
    Device Description
    The Removable Acrylic Herbst appliance is an upper and lower arch system designed to hold the lower jaw forward which increases the lower airway passage and reduces the tendency to snore. The upper and lower appliances are connected by means of a telescoping male and female stainless steel tube (upper) and rod (lower) Herbst mechanism. The system is bilateral, left and right. While the patient can open and close their mouth, the lower jaw arcs as predetermined by the construction of the appliance. The degree to which the patient's lower jaw is supported in an anterior position is determined by the dentist. The Enoch Snorinator is a one-piece appliance designed for the upper arch only. It is a pressureformed anterior repositioning splint which postures the lower jaw forward to alleviate snoring. The anterior portion is formed into a "ramp" shape to engage the lower incisors. This ramp postures the lower jaw into the prescribed position as determined by the dentist. The Allesee Snore Appliance (ASA) is a one-piece upper and lower, pressure-formed splint. The upper and lower jaw plastic appliances are joined together with orthodontic acrylic. The appliance postures the patient's lower jaw in a forward or anterior position. The amount of advancement is patient specific and determined by the dentist. The appliance has a rectangular airway between the upper and lower anterior teeth.
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    K Number
    K060469
    Device Name
    OPTIBOND ALL-IN-ONE
    Manufacturer
    SYBRON DENTAL SPECIALTIES, INC.
    Date Cleared
    2006-03-28

    (33 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Why did this record match?
    Applicant Name (Manufacturer) :

    SYBRON DENTAL SPECIALTIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OptiBond All-In-One is a self-etching adhesive which combines the ingredients needed for etching, priming, and bonding into a single adhesive solution and is used for direct situations, i.e., light-cured composite and compomer restorations, composite/ceramic/amalgam/metal repairs, cavity sealing for amalgam restorations, lightcured or dual-cured core build-ups, and indirection situations, i.e., veneers, porcelain. composite, and metal-based inlays, onlays, crowns, bridges, endodontic posts, and cavity sealing as a pretreatment for indirect restorations.
    Device Description
    OptiBond All-In-One self-etching adhesive combines the ingredients needed for etching, priming, and bonding into a single adhesive solution, thereby eliminating separate etching and priming steps of the bonding process. OptiBond All-In-One adhesive can be used for the bonding of both direct and indirect restorations. The advantages of using OptiBond All-In-One adhesive include simplified bonding procedures and reduced post-operative sensitivity. OptiBond All-In-One incorporates the proven GPDM adhesive technology used in Optibond Solo Plus, fillers that contain fluoride and nano-fillers. This unique technology ensures the highest level of protection against microleakage while providing high bond strengths to a variety of substrates.
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    K Number
    K053565
    Device Name
    TEMPBOND CLEAR WITH TRICLOSAN
    Manufacturer
    SYBRON DENTAL SPECIALTIES, INC.
    Date Cleared
    2006-02-03

    (43 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Why did this record match?
    Applicant Name (Manufacturer) :

    SYBRON DENTAL SPECIALTIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TempBond Clear with Triclosan is a dual-cured, temporary, eugenol-free, transparent, resin-based cernent with triclosan designed to be used in conjunction with temporary restorations such as crowns, bridges, inlays, onlays and splints.
    Device Description
    TempBond Clear with Triclosan is a dual-cured, temporary, eugenol-free, resin-based cement with triclosan. This base/catalyst cement is flexible and transparent when cured. The device will be packaged in a dual-barrel syringe to eliminate hand mixing. It has excellent flow to permit the restoration to be easily and completely seated. It is strong enough to withstand the stresses of mastication, yet permits easy removal of the restoration when it is desired. TempBond Clear with Triclosan contains triclosan.
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    K Number
    K051933
    Device Name
    EXPASYL POWER APPLICATOR
    Manufacturer
    SYBRON DENTAL SPECIALTIES, INC.
    Date Cleared
    2006-01-03

    (174 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Why did this record match?
    Applicant Name (Manufacturer) :

    SYBRON DENTAL SPECIALTIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Expasyl Power Applicator is a dental handpiece intended to be used to dispense Expasyl, a hemostatic/gingival retracting agent. The paste is dispensed through a tip attached to the cartridge of Expasyl through the use of the Expasyl Power Applicator.
    Device Description
    The Expasyl Power Applicator is a dental handpiece intended to dispense Expasyl, a temporary hemostatic/gingival retracting agent. The paste is dispensed through a tip attached to the cartridge of Expasyl through the use of the Expasyl Power Applicator. The Expasyl Power Applicator is connected to any micro-motor (air or electric) that has a coupling socket and a maximum speed of 40,000 rpm. When the capsule of Expasyl is empty, the plunger on the Expassyl Power Applicator rotates and the applicator makes a repetitive clicking noise which signals the micro-motor must be stopped. The capsule holder of the Expasyl Power Applicator is autoclaveable.
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