Search Results
Found 17 results
510(k) Data Aggregation
K Number
K130920Device Name
CORRECT PLUS 1
Manufacturer
PENTRON CLINICAL
Date Cleared
2013-07-02
(90 days)
Product Code
ELW
Regulation Number
872.3660Why did this record match?
Applicant Name (Manufacturer) :
PENTRON CLINICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Correct Plus 1 is a vinyl polysiloxane impression material which is to be used for taking impression of inlays, crowns & bridges, orthodontic appliances, precision attachments and veneers.
Device Description
Correct Plus 1 impression material (Fast Set) are versatile impression materials designed to accommodate impressions of inlays, crowns and bridges, orthodontic appliances, precision attachments and veneers. The hydrophilic nature of these materials provides outstanding detail in the presence of fluids and exceptional tear strength ensures your detailed impression will remain intact upon removal. Correct Plus 1 impression material provides multiple packaging options and various set times to accommodate all of your impression needs. For optimal patient acceptance, Correct Plus 1 impression material is available in unflavored and Berry.
Ask a Question
K Number
K120013Device Name
TEMPSPAN CLEAR MATRIX
Manufacturer
PENTRON CLINICAL
Date Cleared
2012-05-22
(140 days)
Product Code
ELW
Regulation Number
872.3660Why did this record match?
Applicant Name (Manufacturer) :
PENTRON CLINICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TempSpan Clear Matrix is indicated for:
- Use as a clear template for intra oral polymerization of light activated materials to create temporary restorations.
- Use as a general impression material for monophase impression techniques.
Device Description
TempSpan Clear Matrix Material is a clear preoperative impression material that will reproduce the finest detail resulting in extremely accurate provisional restorations. Use as the preliminary impression material for intraoral and extra-oral polymerization of dual-cure provisional materials. Light curing dual-cure provisional materials may eliminate or drastically reduce the oxygen-inhibited smear layer. TempSpan Clear Matrix Material is a medium viscosity vinyl polysiloxane material. It is packaged in a 50ml auto-mix cartridge, with an oral set time of 2 minutes. TempSpan Clear Matrix Material enables provisional restorations fabricated with dual cure materials to be light cured intra-orally and extra-orally. This process shortens the provisional procedure, minimizing chair time and patient discomfort. Additional features include: clear formula for intra-oral light curing, auto-mix delivery, and a quick set time with a working time of 1 minute and an oral set time of 2 minutes.
Ask a Question
K Number
K111431Device Name
B1P ADHESIVE
Manufacturer
PENTRON CLINICAL
Date Cleared
2011-08-01
(70 days)
Product Code
KLE
Regulation Number
872.3200Why did this record match?
Applicant Name (Manufacturer) :
PENTRON CLINICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
B1P Adhesive is an adhesive designed to be used for all direct and indirect applications including, but not limited to, the following:
Direct Applications
- Direct bonding to dentin and/ or enamel .
- Bonding composite to composite, porcelain and/ or metal .
- . Opaquing metal (used in conjunction with an opaque resin stain or cement)
- Bonding with dual cure and self cure composite resins, such as cements and core build up . materials
- Amalgam sealing
- Dentin sealing ●
Indirect applications
- Indirect bonding of all composite, all ceramic, PFM and alloy crowns, bridges, inlays, ● onlays and veneers (used in conjunction with resin luting agents)
- Bonding of fiber and metal posts (in conjunction with resin luting agents) ●
Device Description
B1P Adhesive is a fifth generation dental bonding agent that is intended to be used for direct composite bonding and indirect restoration in combination with a dental restorative material. The formula is used based on a total etch technique and combines the primer and adhesive into one component. The application procedure requires steps of acid etching and rinsing, followed by the application of the B1P Adhesive. It is a light curable adhesive with the option of being dual cured when mixed with the dual cure activator.
Ask a Question
K Number
K102703Device Name
BUILD-IT TOTAL CORE
Manufacturer
PENTRON CLINICAL
Date Cleared
2011-01-05
(107 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
PENTRON CLINICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Build-It Total Core is indicated for use as a core build up material on vital and non-vital teeth, sealing root canal openings, cavity floor liner, post cementation, restorative material and dentin replacement material.
Device Description
Build-It Total Core is a dual-cure, self-adhesive composite with a continuous fluoride release. Build-It Total Core utilizes 4-MET technology to adhere to dentin and cut enamel without a separate bonding agent. Ideal flow characteristics, esthetic and contrast shades, and outstanding physical properties make Build-It Total Core an indispensable tool in every clinician's armamentarium.
Ask a Question
K Number
K091512Device Name
BUILD-IT LIGHT CURE
Manufacturer
PENTRON CLINICAL TECHNOLOGIES
Date Cleared
2009-10-30
(162 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
PENTRON CLINICAL TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Build-It Light Cure is a translucent, light activated composite material designed for core build ups. It is used as core-building material on vital teeth as well as on non-vital teeth, in combination with or without a dental post. It may also be used as a final restorative filling material.
Device Description
Build-It light Cure is a line extension to the current two-component dual curable Build-If FR core material. It is available in a translucent shade only. The depth of cure of the material is > 7 mm to facilitate the bulk is available in a tallslucein silade only. The depart of on the resin mixture and the fillers are immy. The combination of the material dalbarumborosilicate glasses with a little sodium fluoride. The cosonially the connecter of the material facilitates easy adaption to the tooth.
Ask a Question
K Number
K081887Device Name
LUTE-IT II VENEER CEMENT, MODEL NO6
Manufacturer
PENTRON CLINICAL TECHNOLOGIES
Date Cleared
2008-08-29
(58 days)
Product Code
EMA
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
PENTRON CLINICAL TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K072830Device Name
RM BOND, MODEL J032
Manufacturer
PENTRON CLINICAL TECHNOLOGIES
Date Cleared
2007-12-04
(62 days)
Product Code
DYH, EBF
Regulation Number
872.3750Why did this record match?
Applicant Name (Manufacturer) :
PENTRON CLINICAL TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
RM Bond Adhesive product is indicated for orthodontic applications using an indirect bonding treatment technique.
Device Description
The subject device is a light-cured resin adhesive in a methacrylate-based formulation; the light curing feature provides the clinician appropriate flexibility for bracket placement working-time considerations. Product is supplied as refills in a variety of delivery systems; multi-use bottle or syringe as well as a single dose delivery system.
Ask a Question
K Number
K072480Device Name
GENERATION 8 SE ADHESIVE
Manufacturer
PENTRON CLINICAL TECHNOLOGIES
Date Cleared
2007-11-21
(78 days)
Product Code
KLE
Regulation Number
872.3200Why did this record match?
Applicant Name (Manufacturer) :
PENTRON CLINICAL TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Generation 8 SE Adhesive product is indicated for direct bonding of composite and compomer materials to enamel and dentin. Additionally, device use is appropriate for adhesive bonding of other dental materials, such as composite material to ceramics, composite material to composite material and composite material to metals and amalgam.
Device Description
The subject device is a light-cured self-etching, self-priming adhesive in a solvent-free resin formulation. The Generation 8 SE Adhesive performs the etching/priming/bonding process as a single step once the restorative site has been properly prepared. Device composition is approximately 40% filler by weight with filler particle size values less than 2 microns. As with other resin products manufactured by Pentron Clinical Technologies, LLC., the predominant filler for Generation 8 SE Adhesive is a barium borosilicate glass. This filler type provides the subject device with the required strength and radiopacity features. Product is supplied as refills in a variety of delivery systems; multi-use bottle or syringe as well as a single dose delivery system.
Ask a Question
K Number
K072545Device Name
ARTISTE SE FLOWABLE COMPOSITE, MODEL N280
Manufacturer
PENTRON CLINICAL TECHNOLOGIES
Date Cleared
2007-10-26
(46 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
PENTRON CLINICAL TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Artiste SE Flowable Composite product is a self-etch, self-adhesive flowable resin composite indicated for light-cured dental restorations. Applications include:
- Self-etch base liner
- Restorations of carious lesions
- Class 1, III, and V cavity preparations
- Pit and fissure sealant.
Device Description
The subject device is a light-cured self-etching, self-adhesive composite in a BisGMA-free resin formulation. The Artiste SE Flowable Composite requires no application of etchant, primer or adhesive prior to device use once the restorative site has been properly prepared. Device composition is approximately 65% filler by weight with filler particle size values less than 2 microns. As with other resin products manufactured by Pentron Clinical Technologies, LLC., the predominant filler for Artiste SE Flowable Composite is a barium boro-silicate glass. This filler type provides the subject device with the required strength and radiopacity features. Product is supplied in various shades either in multi-use syringe or single dose delivery systems. Product packaging includes kit or refill configuration.
Ask a Question
K Number
K071500Device Name
NANO-BOND II ADHESIVE SYSTEM
Manufacturer
PENTRON CLINICAL TECHNOLOGIES
Date Cleared
2007-08-10
(71 days)
Product Code
KLE, CLA, EMA
Regulation Number
872.3200Why did this record match?
Applicant Name (Manufacturer) :
PENTRON CLINICAL TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Nano-Bond II Adhesive System is used for the adhesion of dentin to various polymeric filling materials (composites) and used with other conditioners or combination of conditioners for bonding composite to metal including amalgam, gold, semi-precious and non-precious alloys, porcelain and glass and luting of same to dentin and enamel.
Device Description
Nano-Bond II Adhesive System is a light-cured, reinforced dentin bonding agent. It is provided in a kit containing two components, Nano-Bond Self-Etch Primer and Nano-Bond II Adhesive and an optional component, Nano-Bond II Dual Cure Activator. The components also are available individually as refills.
Ask a Question
Page 1 of 2