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510(k) Data Aggregation
K Number
K243254Device Name
Parkell Pit and Fissure Sealant
Manufacturer
Date Cleared
2025-08-08
(297 days)
Product Code
Regulation Number
872.3765Why 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
K210259Device Name
Parkell Self-Adhesive Cement
Manufacturer
Date Cleared
2022-01-20
(353 days)
Product Code
Regulation Number
872.3275Why 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
K191103Device Name
Parkell Desensitizer Gel
Manufacturer
Date Cleared
2019-11-22
(211 days)
Regulation Number
872.3250Why 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
K190930Device Name
SmarTemp X1
Manufacturer
Date Cleared
2019-09-05
(148 days)
Regulation Number
872.3770Why 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
K182296Device Name
HyperFil-LV
Manufacturer
Date Cleared
2018-12-14
(112 days)
Product Code
Regulation Number
872.3690Why 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
K172176Device Name
Parkell Universal Adhesive
Manufacturer
Date Cleared
2017-11-21
(125 days)
Product Code
Regulation Number
872.3200Why 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
K151518Device Name
BRUSH&BOND PLUS
Manufacturer
Date Cleared
2015-09-18
(105 days)
Product Code
Regulation Number
872.3200Why 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
K142848Device Name
EAZY PRIMER
Manufacturer
Date Cleared
2015-02-24
(147 days)
Product Code
Regulation Number
872.3200Why 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
K132115Device Name
ABSOLUTE DENTIN 2
Manufacturer
Date Cleared
2014-06-25
(351 days)
Product Code
Regulation Number
872.3690Why 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
K113839Device Name
RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE
Manufacturer
Date Cleared
2012-04-12
(106 days)
Product Code
Regulation Number
N/AWhy 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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