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510(k) Data Aggregation

    K Number
    K240743
    Device Name
    Peak Universal Bond
    Manufacturer
    Ultradent Products, Inc.
    Date Cleared
    2024-03-20

    (2 days)

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

    Ultradent Products, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Use for virtually all etching and bonding needs in restorative dentistry for patients of all ages. Peak Universal Bond is used for desensitizing/sealing of tooth structure. Peak Universal Bond adhesive bonds to the following materials: - · Dentin and Enamel - · Porcelain, Zirconia - Metal - · Composite
    Device Description
    Peak™M Universal Bond is a bottle, syringe, or unit dose delivered bonding resin. It can be used with selfetch or with total etch techniques. It is 7.5% filled with an ethyl alcohol solvent carrier and will cure with most high intensity lights including LEDs. Peak Universal Bond adhesive contains 0.2% chlorhexidine which may ensure long term bond strengths. Its mode of action produces a mechanical occlusion of dentin tubules by the resins, thus reducing tooth hypersensitivity.
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    K Number
    K240694
    Device Name
    FORMA Composite (Shade A3D)
    Manufacturer
    Ultradent Products, Inc.
    Date Cleared
    2024-03-15

    (1 days)

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

    Ultradent Products, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    FORMA Composite is designed for restorations in anterior and posterior teeth. FORMA™ Composite is used for direct and indirect restorations in both the anterior and posterior regions.
    Device Description
    FORMA™ Composite is a Bis-GMA-based restorative composite. FORMA™ composite is designed for restorations in anterior and posterior teeth and is suitable for occlusal surfaces. Its formula contains a zirconia/silica inorganic filler combination and barium glass. FORMA™ composite is shaded based on the VITA shade guide, and is radiopaque. FORMA™ composite has a radiopacity value greater than 2 mm of aluminum has a radiopacity equivalent to that of dentin. Thus, 1 mm of material having a radiopacity equivalent to 1 mm of aluminum has a radiopacity equivalent to that of dentin and 2 mm of aluminum is equivalent to enamel. FORMA™ composite A3D is filled 78% w/w. FORMA™ composite is a nanohybrid composite with nanoparticles entombed within the composite's formulation.
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    K Number
    K221909
    Device Name
    J-Temp
    Manufacturer
    Ultradent Products, Inc.
    Date Cleared
    2022-07-01

    (1 days)

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

    Ultradent Products, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    •Temporary restorations •Splinting between implant copings for impressions to resist impression material distortion •To provide structure for isolation clamping and to act as a barrier for endodontic irrigants • Bite ramps and temporary occlusal buildups during orthodontics
    Device Description
    J-Temp temporary resin is a flowable resin material designed to be durable enough to stay in place after being applied. It is delivered via syringe and light cured.
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    K Number
    K220471
    Device Name
    VALO X, VALO X Accessory Lenses
    Manufacturer
    Ultradent Products, Inc.
    Date Cleared
    2022-02-22

    (4 days)

    Product Code
    EBZ, EAQ, PEQ
    Regulation Number
    872.6070
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ultradent Products, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VALO X curing light is a source of illumination for curing photo-active materials and adhesives. It is also intended to provide illumination to aid in visualization during oral procedures. VALO X curing light accessory/ diffusor lenses are not intended for complete cure of photo-activated materials and adhesives.
    Device Description
    VALO™ X: With its broadband spectrum, VALO™ X curing light is designed to polymerize all light-cured products in the wavelength range of 380-515 nm per ISO 10650:2018. The VALO X curing light can be used in a corded or cordless configuration using the Ultradent VALO rechargeable batteries or provided VALO X cord adapter. The curing light is designed to rest in a standard dental unit bracket or can be custom-mounted using the VALO surface mounting bracket included with the kit. VALO™ X Accessory Lenses: Accessory: PointCure Lens, Mode: Curing Mode, Description: Augments the VALO X curing light to polymerize composite through a translucent prosthetic. Accessory: ProxiCure Ball, Mode: Curing Mode, Description: Augments the VALO X curing light to polymerize composite and help shape contact area matrix of an interproximal restoration. Accessory: Diffuser Lens, Mode: White Light Diagnostic Aid Mode, Description: Augments the VALO X curing light to provide a visual aid for accurate color/shade comparison or whenever natural light is needed. Accessory: Diffuser Lens, Mode: Black Light Diagnostic Aid Mode, Description: Augments the VALO X curing light to provide visualization of fluorescing chemicals in dental resins. Accessory: Interproximal Lens, Mode: White Light Diagnostic Aid Mode, Description: Augments the VALO X curing light in visualization of teeth and dental prostheses. Accessory: Translume, Mode: Curing or Diagnostic Aid Modes, Description: Augments the VALO X curing light in visualization by providing longer wavelength light to transilluminate teeth and dental prostheses.
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    K Number
    K211905
    Device Name
    UltraCal XS
    Manufacturer
    Ultradent Products, Inc.
    Date Cleared
    2021-10-13

    (114 days)

    Product Code
    KIF, EJK
    Regulation Number
    872.3820
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ultradent Products, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    UltraCal XS calcium hydroxide paste is indicated to be used for: - temporary dressing for root canals - apexification and/or perforation - vital pulpotomy - direct pulp capping - indirect pulp capping - root resorption - root canal filling for primary teeth
    Device Description
    UltraCal XS calcium hydroxide paste is an aqueous, 12.0 to 12.5 pH, radiopaque, premixed paste for direct application.
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    K Number
    K211237
    Device Name
    UltraTemp Rez II
    Manufacturer
    Ultradent Products, Inc.
    Date Cleared
    2021-07-13

    (78 days)

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

    Ultradent Products, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    UltraTemp REZ II is indicated for temporization of provisional prosthesis or restorative provisional crowns, bridges, inlays, and on lays).
    Device Description
    UltraTemp™ REZ II temporary resin cement is a low viscosity, temporary luting/filling material featuring a hydrophilic resin-based formula which is recommended for the retention of provisional restorations of provisional prosthesis. UltraTemp REZ II temporary resin cement may also be used for temporary restorative procedures (i.e. provisional crowns, bridges, inlays, and on lays). It is available in Fast Set (1 to 2 minutes) and Regular Set (2 to 3 minutes).
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    K Number
    K190627
    Device Name
    VALO Grand Corded
    Manufacturer
    Ultradent Products, Inc.
    Date Cleared
    2019-04-29

    (48 days)

    Product Code
    EBZ
    Regulation Number
    872.6070
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ultradent Products, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The source of illumination for curing photo-activated dental restorative materials and adhesives.
    Device Description
    VALO® Grand Corded is a mains-powered, visible light activator for polymerization of dental resins of all photo-initiated dental materials. The VALO® Grand Corded version functions the same as the predicate, VALO® (K083647), as a professional hand-held, LED-based, visible light curing device. The modified device, VALO® Grand Corded, is manufactured from the same materials (anodized aluminum, rubber buttons, LED light source, printed circuit board, silicone adhesive, plastic), is used for the same indications, and has the same intended use as the predicate devices have three power output modes ranging from 800 - 2300 mW/cm2. Both the new device and predicate cure dental composite materials in the 395 -480 nm range using an LED light source. Differences from the predicate include an increased light head diameter to provide a larger curing area over a tooth, an additional LED activation ('power') button, and the middle power mode setting has been increased to make it more central between the Standard and Xtra Power modes. Additionally, VALO Grand Corded will include one pair of Blue Light Blocking Glasses, which will replace the Light Shield.
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    K Number
    K173163
    Device Name
    ChlorCid, ChlorCid V, ChlorCid Surf
    Manufacturer
    Ultradent Products, Inc.
    Date Cleared
    2018-02-09

    (133 days)

    Product Code
    KJJ
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ultradent Products, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ChlorCid, ChlorCid V and ChlorCid Surf are used for irrigating, instrumentation and debriding of root canal preparations.
    Device Description
    The ChlorCid family of products are aqueous solutions of 3% sodium hypochlorite used for endodontic procedures. When desired, ChlorCid V is a more viscous solution for enhanced flow control and lubrication, and ChlorCid Surf includes a surfactant which assists in the product's ability to penetrate in tight canal spaces.
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    K Number
    K160551
    Device Name
    VALO Grand
    Manufacturer
    ULTRADENT PRODUCTS, INC.
    Date Cleared
    2016-07-13

    (135 days)

    Product Code
    EBZ
    Regulation Number
    872.6070
    Why did this record match?
    Applicant Name (Manufacturer) :

    ULTRADENT PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VALO® Grand is a source of illumination for curing photo-activated dental restorative materials and adhesives.
    Device Description
    VALO® Grand is a battery operated, visible light activator for polymerization of dental resins of all photo-initiated dental materials. The VALO® Grand version functions the same as the predicate, VALO® Cordless, K110582, as a professional hand-held, LED-based, visible light curing device. The modified device, VALO® Grand, is manufactured from the same materials (anodized aluminum, rubber buttons, LED light source, printed circuit board, silicone adhesive, plastic), is used for the same indications, and has the same intended use as the predicate device. Both devices have three power output modes ranging from 800 – 2300 mW/cm². Both the new device and predicate cure dental composite materials in the 395 – 480 nm range using an LED light source. Differences from the predicate include an increased light head diameter to provide a larger curing area over a tooth, an additional LED activation ('power') button for better ergonomics, and the middle power mode setting has been changed from 1400 to 1600 mW/cm², which makes it more central between the Standard and Xtra Power modes.
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    K Number
    K152064
    Device Name
    Astringedent Clear
    Manufacturer
    ULTRADENT PRODUCTS, INC.
    Date Cleared
    2015-09-24

    (62 days)

    Product Code
    MVL
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    ULTRADENT PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Astringedent Clear is intended for sulcus retraction prior to impression making and to control bleeding and gingival oozing in restorative and operative dentistry used with gingival retraction cord and/or the solution facilitates the insertion of the cord into the sulcus.
    Device Description
    Astringedent Clear is a 12% w/w aluminum chloride solution in a non-viscous, aqueous vehicle. It leaves no residue or stain, making it ideal for use in the esthetic zone. It is packaged in two configurations: 30 mL IndiSpense, 30 mL bottle packaged with retraction cord. It is used both for obtaining clear dental impressions, as well as operative dental procedures requiring hemostasis and fluid control.
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