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510(k) Data Aggregation
K Number
K192597Device Name
Cytrans Granules
Manufacturer
GC America, Inc.
Date Cleared
2020-08-17
(332 days)
Product Code
LYC
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
GC America, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
-Augmentation or reconstructive treatment of the alveolar ridge.
-Filling of periodontal defects.
-Filling of defects after root resection, apicocetomy, and cystectomy.
-Filling of extraction sockets to enhance preservation of the alveolar ridge.
-Elevation of the maxillary sinus floor.
-Filling of periodontal defects in conjunction with products intended Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR).
-Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).
Device Description
Cytrans Granules is composed of carbonate apatite. The material of Cytrans Granules has been formulated in terms of carbonate apatite content to the mineral content of natural bone. As Cytrans Granules is completely synthetic, there are no animal derived ingredients in the formula. Cytrans Granules is gradually resorbed and eventually replaced with new bone. Resorption is by osteoclasts under acidic conditions. Cytrans Granules is manufactured by a validated manufacturing process which guarantees batch to batch conformity and reproducibility. It is sterilized via gamma irradiation and will be marketed/sold in sterile vials for single use.
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K Number
K153231Device Name
G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer
Manufacturer
GC AMERICA, INC.
Date Cleared
2016-07-06
(240 days)
Product Code
EMA, EBF, KLE
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
GC AMERICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
G-Cem LinkForce
- 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 (up to 2 teeth)
- 4. Permanent cementation of crowns and bridges on implant abutments.
GC DUAL CURE ACTIVATOR
1. Cementation of indirect restorations.
2. Bonding of core build-ups made of light-curing composite or core build-up materials to tooth structure.
3. Bonding of resin cements and core build-up materials and self-cure composites to tooth structure.
TRY-IN PASTE
To evaluate the shade and the fitting of the restoration prior to permanent cementation.
MULTI PRIMER
- 1. Priming of the adherend surfaces of indirect restorations made of glass ceramics, oxide ceramics, hybrid ceramics, composite and metal before luting procedures.
- 2. Intra-oral and extra-oral repair of fractured indirect restorations made of ceramics, hybrid ceramics and composites.
Device Description
G-CEM LinkForce is a dual-cured resin cement. The components consists of Paste A and B, which are filled in a one-body syringe. Both pastes are automixed with a mixing tip. G-CEM LinkForce is available in 4 shades: Translucent, A2, Opaque, Bleach.
GC DUAL CURE ACTIVATOR is a primer to a tooth abutment. It must be used with G-Premio BOND (510(k) No. K143140).
TRY-IN PASTE is a hue-conformity verification material. The product is placed into a dental restoration and set on an abutment tooth to verify hue and conformity. The product has a same color as G-CEM LinkForce.
MULTI PRIMER is a priming agent designed to treat the adherend surface of glass ceramic, oxide ceramic, hybrid ceramic, composite and metal restorations to promote a strong bond to resin-based materials as resin-based cements in case of luting procedures or direct composites in case of repairs.
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K Number
K153253Device Name
GC Reline II
Manufacturer
GC AMERICA, INC.
Date Cleared
2016-03-03
(114 days)
Product Code
EBI
Regulation Number
872.3760Why did this record match?
Applicant Name (Manufacturer) :
GC AMERICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
GC RELINE II is a resilient material for making soft relining of dentures.
Device Description
GC RELINE II is a VPS silicone for relining of dentures. 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. GC Reline II is available in the following viscosities: Soft, Extra Soft, and Extra Extra Soft.
The cartridge is made of high density polyethylene and the cap is made of polypropylene. The mixing tip is made of polypropylene.
GC Reline Primer for Resin is a resin adhesive that is packaged in a glass bottle.
GC Reline Modifier is available in Liquid A and Liquid B and is similar to the Base and Catalyst of the subject device. Liquid A and Liquid B are dispensed in equal amounts onto the mixing pad and mixed together. It is used to modify (activate) the existing reline surface to accept additional Reline II material.
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K Number
K143140Device Name
G-Premio BOND
Manufacturer
GC AMERICA, INC.
Date Cleared
2015-04-20
(168 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
- 1. 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 2. are light cured.
- 3. 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, 4. CAD/CAM hybrid resin crowns and composites.
- 5. Intraoral repairs of porcelain fused to zirconia crowns, porcelain fused to alumina crowns and full zirconia crowns.
- Treatment of hypersensitive teeth. 6.
Device Description
G-Premio BOND is a one component, light-cured bonding agent available in a 5 mL liquid bottle or unit dose.
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K Number
K141562Device Name
MSN-006
Manufacturer
GC AMERICA, INC.
Date Cleared
2014-09-05
(85 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
MSN-006 is a dual-cured, temporary crown and bridge resin. The components consists of Paste A and B, which are filled in a cartridge. Both pastes are automixed with a mixing tip.
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K Number
K133182Device Name
HTFX-222
Manufacturer
GC AMERICA, INC.
Date Cleared
2014-04-09
(174 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 direct and indirect aesthetic restorations: composites, veneers, crowns and bridges (including temporary crowns and bridges), defect margins when margins are in enamel
4. Sealing hypersensitive areas
5. Fissure sealant
6. Direct restorative for small Class I, II, III, IV, and V cavities
Device Description
HTFX-222 is a light cured nano-filled radiopaque composite resin filled in a syringe. The device is a universal type. The material is available in 8 shades: A1, A2, A3, A3.5, A4, A02, AO3 and CV
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K Number
K133824Device Name
CERASMART
Manufacturer
GC AMERICA, INC.
Date Cleared
2014-03-14
(87 days)
Product Code
EBF, EBG
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
GC AMERICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The product is indicated for inlays, onlays, veneers and full crown restorations, including crowns on implants.
Device Description
CERASMART is a pre-cured composite block for milling CAD/CAM indirect restorations. The milled device is used for the restorations of both anterior and posterior teeth.
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K Number
K123631Device Name
MFP-051
Manufacturer
GC AMERICA, INC.
Date Cleared
2013-07-23
(242 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. Direct restorative for class I, II, III, IV, V cavities.
2. Direct restorative for wedge-shaped defects and root surface cavities.
3. Direct restorative for veneers and diastema closure.
Device Description
MFP-051 is a light-cured, nano-filled radiopaque composite resin filled in either a syringe or unitip. The device is a universal type. The material is available in 17 shades. The device is used for the restorations of both anterior and posterior teeth.
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K Number
K113816Device Name
GC AADVA ABUTMENT- ZIRCONIUM-BO AC BH SV
Manufacturer
GC AMERICA, INC.
Date Cleared
2013-01-30
(400 days)
Product Code
NHA
Regulation Number
872.3630Why did this record match?
Applicant Name (Manufacturer) :
GC AMERICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
GC Aadva™ Abutments -Zirconia - Bo Ac Bh Sv are dental implant abutments for use with partially or fully edentulous patients to restore chewing function by attachment to a dental implant fixture placed in the maxilla or mandible. Each abutment is accompanied by a screw in order to engage corresponding dental implant fixture.
Device Description
The "GC Aadva™ Abutments – Zirconia – Bo Ac Bh Sv" are abutments which are placed into a dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for use with the following implant fixtures: Institut straumann AG Bone Level Implant NC and RC, Nobel Biocare AB NobelActive NP and RP, BioHorizons Tapered Internal Implant, and Zimmer Dental Inc. Tapered Screw-Vent. The abutment components comply with ISO 13356:2008 – Implants for Surgery – Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP). The abutments are mounted into the implant with a screw made of Titanium grade Ti-6Al-4V, which meets the requirements of ISO : 5832-3.
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K Number
K120521Device Name
GC BLUE SILICONE
Manufacturer
GC AMERICA, INC.
Date Cleared
2012-05-10
(79 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
GC BLUE SILICONE is a silicone impression material for fit check by detecting the high spots and pressure points of ceramic crowns, ceramic bridges, ceramic inlays and the occlusal surface.
Device Description
GC BLUE SILICONE is available in a 2-part cartridge device in which part 1 is a base silicone paste and part 2 is a catalyst silicone.
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