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510(k) Data Aggregation

    K Number
    K232393
    Device Name
    BluTube® Dental Unit Water Purification Cartridge (BluTube®); Model Numbers: WB180, WB90, Z3 Waterline Purification Straws, Dental Unit Water Purification Cartridge
    Manufacturer
    ProEdge Dental Products, Inc.
    Date Cleared
    2023-10-27

    (79 days)

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

    ProEdge Dental Products, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BluTube@Dental Unit Water Purification Cartridge is for use on dental unit water lines attached to the dynamic dental instruments, i.e., high-speed handpiece, three-way airwater syringe and ultrasonic scaler. This cartridge in conjunction with currently recommended practices regarding sterilization and flushing of dental instruments reduces bacteria from the water supplied to the instruments to less than 200 CFU/mL, a level that will meet or exceed the current American Dental Association (ADA) recommendations for water quality.
    Device Description
    BluTube® is a dental unit waterline purification cartridge intended for use at dental offices to reduce microbial bioburden in dental unit waterlines (DUWLs). BluTube® is placed in-line with the pick-up tube of the water supply bottle of a dental operative unit (DOU). Once installed, water flows into the device and through the iodinated resin chamber. Bacterial populations in the treated water are reduced through the antimicrobial action of iodine, which is released from the iodinated resin and into the treated water. Treated water expelled from BluTube® can be used as an irrigant/coolant for nonsurgical dental procedures and is appropriate for use in dental instruments like air/water syringes or high-speed handpieces.
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    K Number
    K231338
    Device Name
    3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment
    Manufacturer
    3M ESPE Dental Products
    Date Cleared
    2023-05-10

    (2 days)

    Product Code
    LBH
    Regulation Number
    872.3260
    Why did this record match?
    Applicant Name (Manufacturer) :

    3M ESPE Dental Products

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    3MIM Clinpro™ Clear 2.1% Sodium Fluoride Treatment is indicated for the treatment of hypersensitive teeth.
    Device Description
    3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment is an aqueous fluoride coating that is applied topically to the tooth surfaces for the treatment of hypersensitive teeth. The product is sweetened with xylitol and sucralose. Clinpro 2.1% Sodium Fluoride Treatment contains 9,500 ppm fluoride and added calcium and phosphate. 3M Clinpro Clear 2.1% Sodium Fluoride Treatment uses the L-Pop™ unit dose dispensing system designed by 3M. Each L-Pop contains 0.5 ml (0.5 grams) of the coating and is offered in mint and melon flavors and a flavorless version.
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    K Number
    K230270
    Device Name
    3M™ VitCal Liner/Base
    Manufacturer
    3M ESPE Dental Products
    Date Cleared
    2023-02-06

    (6 days)

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

    3M ESPE Dental Products

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    3M VitCal Liner/Base is indicated for lining and basing applications under dental restorations. 3M VitCal Liner/Base is also indicated for direct pulp capping.
    Device Description
    3M VitCal liner/base is a two-part paste/paste, light-cured system. The paste/paste materials are contained in a Micro-Mix Syringe Dispensing System. This dispensing system provides simultaneous dispensing and mixing of each component for a consistent mix and direct application into the mouth. The composition is a combination of a resin-modified glass ionomer and calcium-based material. The first paste contains a radiopaque fluoro-aluminosilicate glass and calcium filler. The second paste contains a modified polyalkenoic acid. VitCal liner/base provides the major benefits of glass ionomer cements including adhesion to the tooth structure and sustained fluoride release. Additionally, VitCal linerbase offers a high pH environment and a combination of a prolonged working time with an on-demand set time achieved by light curing.
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    K Number
    K221695
    Device Name
    3M Filtek Supreme Flowable Restorative
    Manufacturer
    3M Company ESPE Dental Products
    Date Cleared
    2022-06-13

    (3 days)

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

    3M Company ESPE Dental Products

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Direct Restoration of all cavity classes (I-V) - Base/liner under direct restorations - Repair of small defects in esthetic indirect restorations - Repair of resin and acrylic temporary materials - Pit and fissure sealant
    Device Description
    FiltekTM Supreme Flowable Restorative is a low viscosity, visible-light activated, radiopaque, flowable nanocomposite. It is available in a variety of tooth-colored shades. Filtek™ Supreme Flowable Restorative contains Bis GMA, TEGDMA, and Procrylat K resins. The fillers are a combination of an Ytterbium Fluoride filler, a non-agglomerated/non-aggregated surface-modified silica filler, and a surface-modified aggregated zirconia/silica cluster filler. The aggregate has an average cluster particle size of 0.6 to 10 microns. The inorganic filler loading is approximately 65% by weight (46% by volume). Filtek Supreme Flowable Restorative is applied to the tooth following the use of a methacrylate-based dental adhesive such as manufactured by 3M, which permanently bonds the restoration to the tooth structure. When irradiated by light, the methacrylate functionalities of the resin and fillers undergo, in conjunction with the photoinitiator system, a light-induced polymerization to form a hard composite that is bonded to the tooth structure with a permanent dental adhesive. The product is available in both syringe and capsule delivery systems.
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    K Number
    K191122
    Device Name
    3M RelyX Pediatric Resin Modified Glass Ionomer Cement
    Manufacturer
    3M ESPE Dental Products
    Date Cleared
    2019-05-29

    (30 days)

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

    3M ESPE Dental Products

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Permanent cementation of pediatric crowns: • Stainless Steel crowns • Zirconia crowns • 3M™ Pediatric Esthetic Crowns
    Device Description
    3MTM RelyX™ Pediatric Resin Modified Glass Ionomer Cement is a radiopaque, fluoride-releasing, resin-modified glass ionomer luting cement. RelyX Pediatric Cement is intended for the cementation of preformed pediatric crowns made of stainless steel, zirconia, and resin composite material. RelyX Pediatric Cement consists of a base paste and a catalyst paste packaged in the Automix delivery system for direct delivery in consistent mix ratios. The mixing tip attachment offers convenience over traditional hand mixed cement systems and delivers consistent mix ratios. The cement is available in a white shade. The Automix syringe contains 8.5 g of cement material. The product provides both selfcuring and light curing mechanisms which makes it uniquely versatile for the cementation of different restorative materials.
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    K Number
    K183476
    Device Name
    3M Filtek Universal Restorative
    Manufacturer
    3M ESPE Dental Products
    Date Cleared
    2019-01-02

    (16 days)

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

    3M ESPE Dental Products

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    · Direct anterior and posterior restorations (including occlusal surfaces) · Core build-ups · Splinting · Indirect restorations including inlays, onlays, and veneers
    Device Description
    3MTM FiltekTM Universal Restorative, is a visible-light activated, restorative composite optimized to create esthetic anterior and posterior restorations. This material provides excellent strength and low wear for durability and improved esthetics with higher level of visual opacity. The shades are body like opacity enabling up to a 2mm depth-of-cure. The pink opaquer can be placed in 1mm thick increments. All shades are radiopaque. Filtek Universal Restorative is offered in the following shades: A1. A2, A3. A3.5. A4, B1. B2, D3. XW, and PO. The pink opaque shade option can be used to mask discolored or stained tooth structure. Filtek™ Universal Restorative is packaged in traditional syringes, for dispensing restorative on a pad outside the mouth, and single-dose capsules for dispensing restorative intraorally. The capsules are dispensed using the 3M ESPE Restorative Dispenser. Capsules may be warmed up to 70°C/158°F for one hour in a commercial warmer prior to use.
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    K Number
    K152110
    Device Name
    e-1 etchants
    Manufacturer
    E DENTAL PRODUCTS
    Date Cleared
    2015-11-20

    (114 days)

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

    E DENTAL PRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Etch enamel, dentin, and glass ionomer cements.
    Device Description
    E Dental Products e-1 etchants are colored 37% phosphoric acid aqueous solution etching gels. E Dental Products e-1 etchants are applied to be step in the tooth restoration process.
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    K Number
    K141081
    Device Name
    FILTEK BULK FILL POSTERIOR RESTROATIVE
    Manufacturer
    3M ESPE DENTAL PRODUCTS
    Date Cleared
    2014-05-08

    (13 days)

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

    3M ESPE DENTAL PRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Direct anterior and posterior restorations (including occlusal surfaces) - Base/liner under direct restorations - Core build-ups - Splinting - Indirect restorations including inlays, onlays and veneers - Restorations of deciduous teeth - Extended fissure sealing in molars and premolars - Repair of defects in porcelain restorations, enamel, and temporaries
    Device Description
    3MTM ESPETM FiltekTM Bulk Fill Posterior Restorative material is a visible-light activated, restorative composite optimized to create posterior restorations simpler and faster. This bulk fill material provides excellent strength and low wear for durability. The shades are semi-translucent and low stress curing, enabling up to a 5 mm depth-ofcure. With excellent polish retention, Filtek™ Bulk Fill Posterior Restorative is also useful for anterior restorations that call for a semi-translucent shade. All shades are radiopaque. Filtek™ Bulk Fill Posterior Restorative is offered in A.I. A2. A3. B1. and C2 shades. Filtek™ Bulk Fill Posterior Restorative is applied to the tooth following use of a methacrylate-based dental adhesive, such as manufactured by 3M™ ESPETM. which permanently bonds the restoration to the tooth structure. Filtek™ Bulk Fill Posterior Restorative is packaged in traditional syringes, for dispensing restorative on a pad outside the mouth, and single-dose capsules for dispensing restorative intraorally. The capsules are dispensed using the 3M ESPE Restorative Dispenser.
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    K Number
    K120453
    Device Name
    FILTEK BULK FILL FLOWABLE RESTORATIVE
    Manufacturer
    3M ESPE DENTAL PRODUCTS
    Date Cleared
    2012-03-19

    (34 days)

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

    3M ESPE DENTAL PRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Base under Class I and II direct restorations . - Liner under direct restorative materials . - . Pit and fissure sealant - Restoration of minimally invasive cavity preparations (including small, ◆ non stress-bearing occlusal restorations) - Class III and V restorations . - . Undercut blockout - Repair of small enamel defects . - Repair of small defects in esthetic indirect restorations . - Repair of resin and acrylic temporary materials . - As a core build-up where at least half the coronal tooth structure is . remaining to provide structural support for the crown
    Device Description
    Filtek™ Bulk Fill Flowable Restorative, is a low viscosity, visible-light activated, radiopaque, flowable. This low stress flowable material is semitranslucent enabling a 4mm depth of cure. The restorative is packaged in capsules and syringes. The shades offered with Filtek™ Bulk Fill flowable are U (Universal), A1, A2, and A3. Filtek™ Bulk Fill flowable contains bisGMA, UDMA, bisEMA(6) and Procrylat resins. The fillers are a combination of ytterbium trifluoride filler with a range of particle sizes from 0.1 to 5.0 microns and zirconia/silica with a particle size range of 0.01 to 3.5 µm. The inorganic filler loading is approximately 64.5% by weight (42.5% by volume). A dental adhesive is used to permanently bond the restoration to the tooth structure. Filtek™ Bulk Fill Flowable Restorative is a modification of predicate device Filtek™ Supreme Ultra Flowable Restorative. The formulation was modified to increase depth of cure, while decreasing polymerization shrinkage stress.
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    K Number
    K111185
    Device Name
    RELYX LUTING PLUS AUTOMIX
    Manufacturer
    3M ESPE DENTAL PRODUCTS
    Date Cleared
    2011-05-05

    (8 days)

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

    3M ESPE DENTAL PRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended for use as a dental cement. RelyX™ Luting Plus Automix (Lexus-2) is indicated for Luting: - Luting porcelain fused to metal crowns and bridges to tooth structure, amalgam, composite or glass ionomer core build ups; - Luting metal inlays, onlays or crowns; - Luting pre-fabricated and cast post cementation - Luting orthodontic appliances - Luting crowns made with all-alumina or all zirconia cores such as Procera® AllCeram
    Device Description
    3M™ ESPE™ RelyX™ Luting Plus Automix (Lexus-2) is a radiopaque, fluoride-releasing, resinmodified glass ionomer luting cement. It is self-curing with an option for tack light curing of excess cement. RelyX Luting Plus Automix (Lexus-2) consists of a base (Paste A) and catalyst (Paste B) packaged in an automix (dual barrel) syringe. The dual barrel syringe dispenses paste A and Paste B. The cement is available in a white shade.
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