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Found 22 results
510(k) Data Aggregation
K Number
K200798Device Name
G-CEM ONE
Manufacturer
GC America Inc.
Date Cleared
2020-11-24
(243 days)
Product Code
EMA
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
GC America Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
1. Cementation of all types of all ceramic, resin and metal-based inlays, onlays, crowns and bridges.
2. Cementation of metal, ceramic, fiber posts, and cast post and cores.
3. Cementation of all ceramic and composite veneers.
4. Final cementation of crowns and bridges on implant abutments.
Device Description
G-CEM ONE is a dual-cured self-adhesive resin cement with a tooth primer, G-CEM ONE ADHESIVE ENHANCING PRIMER. The mixed cement hardens through polymerization. The adhesive component is an acidic monomer which also can polymerize with frame-forming monomers. This copolymerizing reaction provides higher physical strength than resin-modified glass ionomer cements. Using the primer on the prepared tooth, surface modification and cement polymerization are promoted and hardened along with the cement. The cement syringe consists of Paste A and B, which are filled in a one-body/two chamber syringe. Both pastes are automixed with a mixing tip and applied directly to restorations or prepared cavity.
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K Number
K200682Device Name
BZF-29
Manufacturer
GC America Inc.
Date Cleared
2020-10-02
(200 days)
Product Code
KLE
Regulation Number
872.3200Why did this record match?
Applicant Name (Manufacturer) :
GC America Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
BZF-29 is a two component (PRIMER and ADHESIVE), light-cured bonding agent suitable for:
- Bonding of light cured composites and acid modified composites (compomers) to tooth structure.
- Bonding of dual cured luting and core build up composites to tooth structure as long as these materials are light cured.
- Intraoral repairs of porcelain fused to metal crowns and composite veneer crowns with metal backing.
- . Intraoral repairs of all ceramic crowns (except zirconia and alumina), hybrid resin jacket crowns, CAD/CAM hybrid resin crowns and composites.
- . Intraoral repairs of porcelain fused to zirconia crowns, porcelain fused to alumina crowns and full zirconia crowns.
- . Treatment of hypersensitive teeth.
Device Description
BZF-29 is a two component, light-cured bonding agent to bond light-cured composite resins to tooth structure, composites, hybrid ceramics, ceramics and metal surfaces, and for the treatment of hypersensitive teeth.
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K Number
K193113Device Name
GC Temp Print
Manufacturer
GC America Inc.
Date Cleared
2020-07-09
(240 days)
Product Code
EBG
Regulation Number
872.3770Why did this record match?
Applicant Name (Manufacturer) :
GC America Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
1. Fabrication of temporary crowns, bridges, inlays, onlays and veneers
2. Fabrication of long-term temporary restorations
Device Description
GC Temp PRINT is 3D printable light curing composite for temporary crown and bridge. The device consists of a paste delivered in a bottle. GC Temp PRINT is fabricated with certain Digital Light Processing/Stereolithography Apparatus (DLP/SLA)a` 3D printers and post cured with light curing device into dental restorations, which are then bonded to tooth structure with adhesive temporary cement.
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K Number
K193484Device Name
GC Fuji Triage EP
Manufacturer
GC America Inc.
Date Cleared
2020-07-02
(198 days)
Product Code
EMA
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
GC America Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
1. Pit & Fissure Sealant and Root Surface Sealant
2. Hypersensitivity due to abrasion and early non-cavitated lesions
3. Protection immature enamel
4. Temporary filling including endodontic access
Device Description
GC Fuji Triage EP is a bioactive glass ionomer for temporary restorative material. The device consists of powder and liquid filled in a capsule and is mixed with a capsule mixer. Then, the mixture is applied directly to a cavity with a capsule applier. As an additional improvement, a proprietary elongation tip can be attached to the capsule nozzle which enables access to small or deep cavities. GC Fuji Triage EP contains CPP-ACP (casein phosphopeptide - amorphous calcium phosphate) in the formulation. CPP-ACP was added to moderate the strength of cement for its use and provide a source of Ca+ and HP04-2. CPP-ACP was chosen as the additive for regulating the strength because it does not interfere with the setting reaction of the material.
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K Number
K192260Device Name
everX Flow
Manufacturer
GC America Inc.
Date Cleared
2019-11-22
(93 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
GC America Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
everX Flow is a reinforcing dentin replacement material suitable for:
- 1. All direct composite restorations including large posterior cavities.
- 2. Deep cavities and endo-treated teeth.
- 3. Cavities with missing cusps or after amalgam removal and cavities where inlays would also be recommended.
- 4. Core build-up
Device Description
everX Flow is a light cured, short-fiber-reinforced composite for dentin replacement for the restoration of posterior and anterior teeth. EverX Flow is filled in a syringe. The material is available in two shades, Bulk shade and Dentin shade.
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K Number
K182854Device Name
GC FujiCEM 2 (Improved)
Manufacturer
GC America Inc.
Date Cleared
2019-07-11
(274 days)
Product Code
EMA
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
GC America Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- -Cementation of metal-based inlays, onlays, crowns and bridges
- -Cementation of resin inlays, onlays, crowns and bridges
- Cementation of all ceramic inlays -
- -Cementation of high strength (e.g. zirconia based, lithium disilicate) ceramic onlays, crowns and bridges
- Cementation of metal, ceramic and fiber posts -
Device Description
GC FujiCEM 2 (Improved) is a resin modified glass ionomer luting cement. The device is composed of the two pastes, Paste A and Paste B, packaged in an automix dual barrel syringe.
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K Number
K180917Device Name
GC Acrylic Primer
Manufacturer
GC America Inc.
Date Cleared
2018-11-20
(225 days)
Product Code
KLE
Regulation Number
872.3200Why did this record match?
Applicant Name (Manufacturer) :
GC America Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Increases the adhesiveness of light-curing composites to conventional acrylic resins used in dental laboratory procedures (e.g., modification of denture teeth/denture base resins)
Device Description
GC ACRYLIC PRIMER is a primer which raises the adhesiveness to acrylic resin and composite resin. GC ACRYLIC PRIMER is intended to use for bonding acrylics to acrylic resin, composite to composite resin, and acrylics to composite resin respectively.
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K Number
K181011Device Name
AIM2
Manufacturer
GC America Inc.
Date Cleared
2018-07-12
(86 days)
Product Code
ELW
Regulation Number
872.3660Why did this record match?
Applicant Name (Manufacturer) :
GC America Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AIM2 is a silicone impression material for taking oral impressions.
Device Description
AIM2 is a VPS silicone impression material. The components consist of the base silicone paste and the catalyst silicone paste that are extruded from a cartridge and are automixed with a mixing tip. AIM2 is available in one viscosity. The cartridge is made of high density polyethylene and the cap is made of polypropylene. The mixing tip is made of polypropylene.
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K Number
K172382Device Name
GC Fuji Direct
Manufacturer
GC America Inc.
Date Cleared
2018-04-02
(237 days)
Product Code
EMA, EBF
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
GC America Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
1. Class III and V restorations
2. Restoration of primary teeth
3. Core build-up
4. Cases where radiopacity is required
5. Base material for Class I and Class II cavities using a sandwich laminate technique.
Device Description
GC Fuji Direct is a light-cured resin-modified restorative glass ionomer cement. The device consists of two pastes filled in a Paste Pak Cartridge. Paste A and B are dispensed with Paste Pak Dispenser II and hand mixed. Paste A and B can also be automixed by attaching the GC Fuji Direct Mixing Tip to the Paste Pak Dispenser II and applied directly to the prepared cavity. The bioactive material sets by acid-base reaction of fluoroalumino-silicate glass and Polyacrylic acid, and polymerization of methacrylate monomers.
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K Number
K173500Device Name
NMF004A
Manufacturer
GC America Inc.
Date Cleared
2018-03-08
(115 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
GC America Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
1. Liner or base
2. Blocking out undercuts
3. Repair of (in) direct aesthetic restorations, temporary crown & bridge, defect margins are in enamel
4. Sealing hypersensitive areas
5. Fissure sealant
6. Direct restorative for Class I, II, III, IV, V cavities
7. Core build-up
Device Description
NMF004A is a light cured nano-filled radiopaque composite resin filled in a syringe. The device is used for the restorations of both anterior and posterior teeth. The material is available in 30 shades.
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