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510(k) Data Aggregation
K Number
K222830Device Name
Rainbow 360
Manufacturer
Kerr Corporation
Date Cleared
2023-01-12
(115 days)
Product Code
KLE
Regulation Number
872.3200Why did this record match?
Applicant Name (Manufacturer) :
Kerr Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Rainbow 360 is a universal bonding agent intended to bond methacrylate-based restorative materials, cements and sealants to dentin, enamel, and various indirect restorative substrates. It can be used in a self-etch mode, selective etch mode or in a total-etch mode for both direct and indirect dental restorative procedures.
Direct Applications
- Light-cured, self-cured and dual-cured composite and compomer restorations.
- Composite/ceramic/metal repairs.
- Tooth preparation and root surface sealer.
- Cavity sealing for amalgam restorations.
- Light-cured or dual-cured core build-ups.
- Bonding of methacrylate-based fissure sealants.
Indirect Applications
- Cementation of veneers
- Cementation of porcelain, composite, and metal-based restorations
- Cementation of endodontic posts
- Cavity sealing as a pretreatment for indirect restorations.
- Prime metal, ceramic, and composite substrates/restorations.
Device Description
The subject device, Rainbow 360, is a single-component universal dental adhesive intended for direct and indirect dental restorations. Rainbow 360 is formulated to provide reliable bond strengths with any etch technique, on all common substrates and in combination with any resin cements without auxiliary products (silane or metal primers) even in absence of light. Rainbow 360 is available in bottles for multiple uses and Unidose™ for single use. Rainbow 360 is intended for general population use by a dental professional.
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K Number
K221255Device Name
SimpliShade Bulk Fill, SimpliShade Bulk Fill Flow
Manufacturer
Kerr Corporation
Date Cleared
2022-08-31
(121 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
Kerr Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SimpliShade Bulk Fill is indicated for:
- Direct placement of anterior and posterior restorations.
- Core build-ups.
- Repair of defects in restorations.
The SimpliShade Bulk Fill Flow is indicated for:
- Base/liner under Class I and Class II direct restorations.
- Pit and fissure sealant.
- Restoration of small cavities.
- Class III and V restorations.
- Blocking out undercuts.
- Small core build-ups.
- Repair of resin and acrylic provisional restorations.
Device Description
SimpliShade™ Bulk Fill Composite is offered in two types of viscosities: the high viscosity formula will be branded as SimpliShade™ Bulk Fill; the low viscosity formula will be branded as SimpliShade™ Bulk Fill Flow.
SimpliShade Bulk Fill is an intra-oral, light-cured, esthetic, resin-based nanohybrid dental restorative that is designed for the placement of direct restorations. SimpliShade Bulk Fill is designed to be used after placement of a dental adhesive, such as a product from the Kerr OptiBond™ family. SimpliShade Bulk Fill is available in Unidose™ compules and syringe delivery systems that are suitable for occlusal surfaces. The product offers allows a technique in which a cavity up to 5 mm in depth can be filled and cured in a single increment. SimpliShade Bulk Fill is offered in one universal shade to optically blend with a range of VITA™ shade guide equivalents. This composite can be polished with a wide variety of polishing discs, rubber cups, and brushes.
SimpliShade Bulk Fill Flow is an intra-oral, light-cured, esthetic, resin-based nanohybrid dental restorative that is designed to be used as a base or liner in Class I and II restorations and must be overlayed with a composite resin to replace the occlusal surfaces. It is also suitable to be used on nonocclusal-contact surfaces, such as pit and fissures, core build-ups and Class III and V restorations. SimpliShade Bulk Fill Flow is available in Unidose™ compules and syringe delivery systems. The product allows a technique in which a cavity up to 4 mm in depth can be filled and cured in a single increment. SimpliShade Bulk Fill Flow is offered in one universal shade to optically blend with a range of VITAM shade guide equivalents. Once light cured, the composite can be finished and polished using conventional finishing and polishing instruments.
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K Number
K191548Device Name
Nexus Universal Self-Cure
Manufacturer
Kerr Corporation
Date Cleared
2019-10-11
(121 days)
Product Code
EMA
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
Kerr Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Nexus Universal Self-Cure is a bonded resin cementation of indirect restoration of indirect restorations including veneers, inlays, onlays, crowns, bridges, posts, and the cementations to implant abutments. Nexus Universal Self-Cure can be used for the cementation of ceramic, porcelain, resin, metal-based, zirconia, and CAD/CAM block materials. Nexus Universal Self-Cure can also be used for the adhesive bonding of amalgam restorations and as a core build-up material.
Device Description
Nexus Universal Self-Cure, manufactured by Kerr Corporation, is a two-component, auto-mixing, dual-cure bonded resin cement consisting of catalyst and base paste at a 4:1 ratio, packaged into a syringe extruded out with an automix tip prior to use. The cement is designed to simplify cementation of restorative substrate such that product can be used with adhesive/bonding agents without the need to light-cure the adhesive/bonding agent on the tooth structure and to eliminate the need for primer treatment on the substrate prior to cement applications. Nexus Universal Self-Cure will be available in various shades.
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K Number
K182162Device Name
OptiBond eXTRa Universal
Manufacturer
Kerr Corporation
Date Cleared
2018-11-07
(89 days)
Product Code
KLE
Regulation Number
872.3200Why did this record match?
Applicant Name (Manufacturer) :
Kerr Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Direct Bonding Applications
- Light-cured composite and compomer restorations. .
- . Composite/ceramic/metal repairs.
- o Cavity sealing for amalgam restorations.
- Sealing of hypersensitive and/or exposed root surfaces. .
- . Core build-ups (self-cured, light-cured, or dual-cured).
Indirect Bonding Applications
- Veneers. .
- . Self-cure, dual-cure, light-cure resin cements and core buildup materials.
- Porcelain, ceramic (including zirconia-based, lithium disilicate-based and . alumina-based), composite, and metal-based (including precious and non-precious metal inlays, onlays, crowns, bridges.
- . Endodontic posts.
- Cavity sealing as a pretreatment for indirect restorations. .
Device Description
OptiBond eXTRa Universal is a two-component universal adhesive system including a PRIMER and an ADHESIVE. The OptiBond eXTRa Universal PRIMER provides effective etching to enamel and dentin without the need for a separate phosphoric acid etch, thus simplifying the bonding procedure (self-etch technique). OptiBond eXTRa Universal is compatible with total etch and selective etch techniques. The OptiBond eXTRa Universal ADHESIVE is 15% filled with 0.4 micron barium glass to help reinforce bond strength.
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K Number
K162948Device Name
Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated Retraction Cord/Materials
Manufacturer
KERR CORPORATION
Date Cleared
2017-08-08
(291 days)
Product Code
MVL
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
KERR CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Aluminum Chloride impregnated retraction material are for the temporary retraction of the gingival margins and hemostasis procedures. The Retraction Cord is place the gingival tissues for a short period prior to making an impression or for other restorative procedures.
Device Description
As part of a tissue management procedure, Styptin, Hemogin-L, Hemodettes, and GingiGEL are aluminum chloride containing astringent/ hemostatic solutions and gels that are intended to be supplied with gingival retraction cord or cotton pellets that are either pre-impregnated or for end-user impregnation by soaking the cords or cotton pellets in these solutions. The aluminum chloride impregnated retraction material is then packed into the sulcus to temporarily displace gingival tissue to expose the sub-gingival margins and control sulcular seepage and hemorrhage for impression taking and other restorative treatments. The supplied retraction material is available as an aqueous aluminum chloride solution or gel and either unit-dose 2"-pieces of braided cotton cord, braided cotton-polyester cord, or unit-dose cotton pellets.
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K Number
K163064Device Name
Demi Ultra
Manufacturer
KERR CORPORATION
Date Cleared
2017-07-18
(258 days)
Product Code
EBZ
Regulation Number
872.6070Why did this record match?
Applicant Name (Manufacturer) :
KERR CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Demi Ultra is a Light Emitting Diode (LED) visible light curing device used for the polymerization of light-cured materials by dental professionals.
Device Description
The Demi Ultra is a Light Emitting Diode (LED) visible light curing device used for the polymerization of light-cured materials by dental professionals. The Demi Ultra consists of a handpiece, LED light curing attachment, and charging dock. The aluminum and plastic molded handpiece contains two (2) ultracapacitors (electric double-layer capacitors), printed circuit boards containing the electronics and user interface buttons, receptacle for retaining the LED light curing attachment, and receptacle for interfacing with the charging dock. The LED light curing attachment contains the curing LED, clear lens and two (2) copper head spreaders, all over molded in plastic. The charging dock contains printed circuit boards containing electronics to support charging the handpiece and built-in LED radiometer functionality. For the handpiece, a digital circuit and microprocessor is utilized to control three (3) different curing modes (5, 10 and 20 seconds). Each mode specifies LED curing output and optional audible beep timing. The handpiece uses one button to activate the LED curing output and another to select the curing time mode. For the charging dock, a digital circuit and microprocessor is utilized to monitor the charging of the handpiece ultracapacitors, as well as respond to light at the radiometer input by illuminating lights on a radiometer meter. Demi Ultra is required to be used with an FDA cleared barrier sleeve.
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K Number
K162536Device Name
GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction Cord
Manufacturer
KERR CORPORATION
Date Cleared
2017-02-03
(144 days)
Product Code
MVL
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
KERR CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction Cord are for the temporary retraction of the gingival margins and hemostasis procedures. The Retraction Cord is placed in the sulcus to displace the gingival tissues for a short period prior to making an impression or for other restorative procedures.
Device Description
Dental retraction materials are used to aid in creating accurate impressions of subgingival margins by temporary gingival displacement, and control of sulcular seepage and hemorrhage. Cords are impregnated with Aluminum Potassium Sulfate. The braided GingiBraid+ and the knitted GingiKnit+ are made of cotton fiber with a different color strand running through the cord for identification of the diameter. Retraction Cords have a yellow background color for medicament identification. The usage is inherently of transient nature. Typical exposure time is less than five minutes. The braided and knitted cord configurations are available in different sizes to fit the sulcus.
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K Number
K162164Device Name
GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord
Manufacturer
KERR CORPORATION
Date Cleared
2017-01-13
(163 days)
Product Code
MVL
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
KERR CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord are for the temporary retraction of the gingival margin. The Retraction Cord is placed in the sulcus to displace gum tissue for a small period of time in dental procedures.
Device Description
GingiKnit+, GingiBraid+, and GingiBraid+ ShortCut Non-Impregnated Retraction Cord are dental retraction materials used to aid accurate impressions of sub-gingival margins by temporary gingival displacement, control sulcular seepage and control hemorrhage. Non-impregnated retraction materials are to be used in combination with an astringent/hemostatic solution of choice. The usage is inherently of transient nature. Typical exposure time is less than five minutes. The non-impregnated retraction materials consists only of braided or knitted cotton yarn soaked with an aqueous surfactant solution and then dried to facilitate absorption of medicament containing retraction solution of dentist's choice into the cotton cord. The braided and knitted cord configurations are available in different sizes to fit the sulcus.
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K Number
K162436Device Name
EndoVac Pure
Manufacturer
Kerr Corporation
Date Cleared
2016-12-21
(112 days)
Product Code
NYL
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
Kerr Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EndoVac™ Pure System is intended for the delivery and evacuation of endodontic irrigation solutions and removing debris of injured or necrotic pulp tissue during root canal procedures.
Device Description
The EndoVac Pure™ system builds on the EndoVac System and presents a unique way to irrigate during root canal treatments. The system is an apical negative pressure system that draws fluid apically by way of evacuation, reducing the risk of apical irrigant extrusion during root canal procedures. The vacuum is routed through the system and controlled independently through the dental chair vacuum system. The fluid delivery is controlled by peristaltic pumps. The pumps are driven by Printed Circuit Board Assemblies (PCBA) and controlled by Field Programmable Gate Array (FPGA) configuration files.
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K Number
K162257Device Name
P1145 Dental Restorative
Manufacturer
Kerr Corporation
Date Cleared
2016-11-07
(88 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
Kerr Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
P1145, a nanohybrid dental restorative, is indicated for direct placement in all cavity classes in anterior and posterior teeth. Additional indications include: repair of enamel defects, repair of provisionals, repair of porcelain restorations, minor occlusal build-ups, core build-ups and incisal abrasions.
Device Description
P1145 is a light-cured, esthetic, resin-based nanohybrid dental restorative designed for direct placement in both anterior and posterior restorations. It is designed to be used after placement of a dental adhesive. Once placed, the composite can be easily sculpted to the desired shape, and after curing, can easily be finished and polished to achieve a highly esthetic restoration.
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