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510(k) Data Aggregation

    K Number
    K243254
    Device Name
    Parkell Pit and Fissure Sealant
    Manufacturer
    Date Cleared
    2025-08-08

    (297 days)

    Product Code
    Regulation Number
    872.3765
    Why did this record match?
    Applicant Name (Manufacturer) :

    Parkell, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K210259
    Device Name
    Parkell Self-Adhesive Cement
    Manufacturer
    Date Cleared
    2022-01-20

    (353 days)

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

    Parkell, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Parkell Self-Adhesive Cement is intended for the cementation of indirect restoratives including ceramic, zirconia, composite, and metal-based inlays, onlays, crowns, bridges, and posts.
    Device Description
    Parkell Self-Adhesive Cement is a two-component, dual-cured, self-adhesive resin cement. It is designed for luting of indirect restorations (inlays, onlays, crowns, bridges, and endodontic posts) made of metal alloys, composite resins, porcelain, lithium disilicate or zirconia. The material also exhibits high bond strength and is radiopaque to allow visibility of excess in sub-gingival areas. Parkell Self-Adhesive Cement will cure in 10 seconds with a dental curing light emitting blue light at 430 - 480 nm and a minimum intensity of 600 mW/cm². The product will self-cure in 3-4 minutes at mouth temperature. Parkell Self-Adhesive Cement will be provided in 5 mL auto-mix syringes. The device comprises catalyst and base components, which are combined just prior to use via a static (1:1) mixing tip which is affixed to the dual chamber syringe.
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    K Number
    K191103
    Device Name
    Parkell Desensitizer Gel
    Manufacturer
    Date Cleared
    2019-11-22

    (211 days)

    Product Code
    Regulation Number
    872.3250
    Why did this record match?
    Applicant Name (Manufacturer) :

    Parkell, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Parkell® Desensitizer Gel is indicated for reduction of tooth hypersensitivity by the following treatments: - · treatment of dentin exposed by toothbrush abrasion, periodontal disease, and/or acid erosion; - · treatment of dentin after mechanical tooth cleaning, scaling, and/or root planning; - · treatment of tooth hypersensitivity associated with bleaching: and - · treatment of prepared dentin for fillings and/or prosthetic restorations.
    Device Description
    Parkell® Desensitizer Gel alleviates dental hypersensitivity at treatment sites. It is a gel which requires no mixing prior to use and which is applied to treatment sites using a standard applicator brush. Parkell® Desensitizer releases calcium and phosphate ions at the treatment site and stimulates hydroxyapatite formation on the surface of treated dentin and in dentinal tubules. In this manner, the Device hardens following application and forms a layer of mineral hydroxyapatite as well as hydroxyapatite plugs which occlude dentinal tubules, which results in the treatment of dental hypersensitivity. Parkell® Desensitizer Gel is packaged in any standard single-chamber syringe. The syringe is accompanied by standard snap-in tips and standard applicator brushes.
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    K Number
    K190930
    Device Name
    SmarTemp X1
    Manufacturer
    Date Cleared
    2019-09-05

    (148 days)

    Product Code
    Regulation Number
    872.3770
    Why did this record match?
    Applicant Name (Manufacturer) :

    Parkell, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    SmarTemp® X I is a self-curing composite for the fabrication of temporary crowns and bridges, inlays and veneers. SmarTemp® X1 is intended for the fabrication of: temporary crowns, bridges, inlays, long-term temporaries, and temporary veneers.
    Device Description
    SmarTemp® X1 is a self-curing, resin-based composite, suitable for the fabrication of temporary crowns, bridges, inlays, onlays, and veneers. It is a bis-acryl resin-based material comprising a 10:1 ratio of base to catalyst components, which when expressed by the user from dual-chamber syringes or cartridges mix through standard snap-in accessory mixing tips. SmarTemp® X1 self-cures in approximately 6 minutes at mouth temperature. SmarTemp® X1 is packaged in any standard, opaque, dual-chamber syringe or cartridge suitable for containing a 10:1 ratio of base and catalyst components, respectively. The syringe or cartridge is accompanied by standard snap-in automix tips.
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    K Number
    K182296
    Device Name
    HyperFil-LV
    Manufacturer
    Date Cleared
    2018-12-14

    (112 days)

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

    Parkell, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    HyperFil®-LV is a dual-cure, tooth shade, resin composite which is indicated for Class I, II, III, IV, and V restorations, including root surface cavities, post cementing, and core build-ups.
    Device Description
    HyperFil®-LV is a dual-cure, highly radiopaque, flowable, bulk-fill composite restorative material suitable for direct and indirect restorations. HyperFil®-LV is light-curable to a depth of about 3-4 mm in 40 seconds with a dental curing light emitting at 430 - 480 nm with an intensity of >600 mW/cm². It will also self-cure to any depth in about 4-5 minutes at mouth temperature. HyperFil®-LV contains a combination of filling agents which give restorations constructed with HyperFil®-LV high compressive, tensile, and flexural strength. HyperFil®-LV will be packaged in single dual-chamber 5 mL syringes. The device comprises catalyst and base components, which are combined just prior to use via a mixing tip which is affixed to the dual chamber syringe.
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    K Number
    K172176
    Device Name
    Parkell Universal Adhesive
    Manufacturer
    Date Cleared
    2017-11-21

    (125 days)

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

    Parkell, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    1. Direct dental restorations (e.g., resin-based composites, resin-modified glass ionomers, resin core build-ups, compomers). 2. Indirect dental restorations (e.g., metal, resin-based composite, dental ceramics such as porcelain, pressed ceramic, lithium disilicate, lithium silicate or zirconia). 3. Desensitization of dentin. 4. Sealing of dentin, cementum or enamel.
    Device Description
    The Parkell® Universal Adhesive is a single-component, one-bottle, light-cured universal bonding agent which utilizes proven 4-META and 10-MDP chemistry to enhance penetration into prepared enamel and dentin surfaces and to establish strong bonds to dental surfaces such as restorative composites, metals, dentin, enamel, cementum, and dental ceramics (e.g., porcelain, lithium disilicate, zirconia, or hybrid ceramics). The Device is useful for all direct and indirect dental restorations, desensitizing teeth, and sealing tooth structures against microleakage. Moreover, the Device can be used without prior acid-etching of dentin or cutting of enamel surfaces. The Parkell® Universal Adhesive will be provided in a single bottle, with standard applicator brushes for applying the adhesive to treatment surfaces.
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    K Number
    K151518
    Device Name
    BRUSH&BOND PLUS
    Manufacturer
    Date Cleared
    2015-09-18

    (105 days)

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

    Parkell, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    BRUSH&BOND® PLUS is indicated for: 1. Direct Dental Restorations (e.g., resin-modified glass ionomer, resin core build-ups, compomers). 2. Indirect Dental Restorations (e.g., metal, resin-based composite, dental ceramics (e.g., porcelain, pressed ceramic, lithium disilicate, zirconia). 3. Desensitization of dentin. 4. Sealing of dentin, cementum or enamel.
    Device Description
    BRUSH&BOND® PLUS is a self-etching. self-priming. light-cured bonding system which utilizes proven 4-META chemistry to enhance penetration into prepared enamel and dentin surfaces and to establish strong bonds to dental surfaces such as restorative composites, metals, dentin, enamel, cementum, and dental ceramics (e.g., porcelain, lithium, disilicate, zirconia, or hybrid ceramics). The Device is useful for all direct dental restorations, desensitizing teeth, and sealing tooth structures against microleakage. Moreover, the Device can be used without prior acid-etching of dentin or cutting of enamel surfaces. The BRUSH&BOND® PLUS device is essentially a single-bottle, two-component system, comprising: a liquid resin which comprises monomers and 4-META chemistry, and an activator brush which comprises a bonding promoter to ensure complete activation and polymerization when contacted with the liquid resin. After activation, the activated resin can be applied directly onto restorative surfaces (except dental ceramic surfaces) using the activator brush or any appropriate dental instrument. For ceramic surfaces, the surface must first be coated with a ceramic primer (such as EaZy Primer'M,510K no. 142848) before the activated resin is applied. BRUSH&BOND® PLUS is packaged as a single 3 mL bottle of liguid resin, an accompanying canister containing 100 activator brushes (either standard size or mini/endo size), and accompanying bottles of Parkell's ceramic rimer Ea Primer'M 5mL "A" and "B" bottles).
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    K Number
    K142848
    Device Name
    EAZY PRIMER
    Manufacturer
    Date Cleared
    2015-02-24

    (147 days)

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

    Parkell, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    EAZY PRIMER™ is indicated for use in enhancing bonding between dental ceramics (such as porcelain, lithium disilicate, zirconia or hybrid ceramics) and methacrylate resin-based materials. In addition, EAZY PRIMER™ is indicated for use in enhancing bonding between fractured dental ceramics and methacrylate resin-based materials during intra-oral repair of damaged restorations.
    Device Description
    EAZY PRIMER™ is a two-part, self-cured dental primer which is used for enhancing the bond between dental ceramics (such as porcelain, lithium disilicate, zirconia, or hybrid ceramics) and methacrylate resin-based materials. The device is intended to be used to prepare surface treatments of restorations and repairs. The device comprises both a silane-coupling agent and a phosphate-coupling agent which generate significant bond strengths between dental ceramic surfaces and methacrylate resin-based materials. The device is packaged in two 5-milliliter bottles ("bottle A" and "bottle B"), which will be mixed in a 1:1 ratio just prior to use.
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    K Number
    K132115
    Device Name
    ABSOLUTE DENTIN 2
    Manufacturer
    Date Cleared
    2014-06-25

    (351 days)

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

    PARKELL, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A dual-cure, composite resin core build-up material that is usually used to restore missing tooth structure for which a dental restoration, usually a crown, is fabricated.
    Device Description
    A dual-cure, composite resin, core build-up material that is usually used to restore missing tooth structure for which a dental restoration, usually a crown, is fabricated. It is substantially equivalent to many predicate materials that include self-, light-, and dual-cure types. This material incorporates fluoride-containing (trace amounts) glass filler particles. No Bisphenol-A or its precursors are used in the manufacturing process. The material is supplied in light-safe dual-barrel cartridges.
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    K Number
    K113839
    Device Name
    RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE
    Manufacturer
    Date Cleared
    2012-04-12

    (106 days)

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

    PARKELL, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    RETRACT is a paste containing aluminum chloride which is used for the temporary retraction and hemostasis of the gingival margin during dental procedures such as dental impressions.
    Device Description
    RETRACT is a dental product capable of controlling gingival bleeding, temporarily displacing the marginal gingiva and temporarily drying the gingival sulcus around a tooth. The paste allows the dental clinician to perform operative procedures without interference from moisture or excess soft tissue. RETRACT is supplied in 0.5 ml syringes with a hand plunger, intra-oral tips, Instructions for Use & MSDS.
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