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510(k) Data Aggregation
K Number
K242816Device Name
Quantium
Manufacturer
Bisco, Inc.
Date Cleared
2024-12-17
(90 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
Bisco, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
• Direct anterior and posterior restorations
• Core build ups
• Splinting
• Indirect restorations including inlays, onlays, and veneers
Device Description
Quantium is a light-cured, radiopaque, universal composite. Quantium is designed to blend with the tooth structure when used alone or in the layering technique.
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K Number
K192007Device Name
TheraBase, TheraBase Ca
Manufacturer
Bisco, Inc.
Date Cleared
2020-03-17
(232 days)
Product Code
EMA, CLA
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
Bisco, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- 1. Metal crowns, bridges, inlays (includes porcelain-fused -to- metal and composite-to-metal)
- 2. Porcelain, Ceramic Crowns, inlays, and onlays (includes alumina and zirconia)
- 3. Resin crowns, bridges, inlays, and onlays (resin-based composite-ceramic hybrid)
- 4. Metal (prefabricated or cast) and non-metal/fiber endodontic posts
- 5. Implant supported restorations
- 6. Orthodontic Appliances (brackets, bands)
- 7. Lining and basing applications under restorations
Device Description
TheraBase and TheraBase Ca are a self-etching, self-adhesive, dual-cured resin luting cement and base/liner that is exclusively formulated for luting crowns, bridges, inlays, onlays and posts (prefabricated metal and non-metal/fiber posts, as well as cast posts) and basing/lining under restorations. TheraBase is a paste/paste, fluoride- and calcium-releasing, luting cement and base/liner which requires no etching, no priming or bonding of the prepared surfaces. TheraBase Ca is a paste/paste, calcium-releasing, luting cement and base/liner which requires no etching, no priming or bonding of the prepared surfaces. They are easy-to use, require only a short chair time, and produce a good bond to most dental materials. The cements are available in a Natural shade. They are radiopaque, allowing for easy identification on radiographs.
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K Number
K180344Device Name
TheraCal DC
Manufacturer
Bisco, Inc.
Date Cleared
2018-04-05
(56 days)
Product Code
EJK, CLA
Regulation Number
872.3250Why did this record match?
Applicant Name (Manufacturer) :
Bisco, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TheraCal DC is indicated for use for:
1. Pulpotomy
2. Temporary Filling Material
3. Repair of Root Perforations
4. Repair of Furcation Perforations
5. Repair of Perforating Internal and External Resorptions
6. Root-End Filling in Endodontic Surgery
7. Pulp Exposures (Direct Pulp Capping)
8. Protective Liner (Indirect Pulp Capping) and Base for Use Under a Variety of Substrates
Device Description
TheraCal DC is a biocompatible, dual-cured, resin-modified calcium silicate that is used to treat damaged dentin in both the crown and the root. TheraCal DC's precise placement allows its use in all deep cavity preparations and endodontic repairs. The dual-cure set permits immediate placement and condensation of the restorative material. Its proprietary formulation allows for a command set with a light curing unit while maintaining ease of placement due to its thixotropic properties.
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K Number
K171147Device Name
REVEAL Bulk
Manufacturer
Bisco, Inc.
Date Cleared
2017-08-04
(107 days)
Product Code
EBF, CLA
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
Bisco, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
1) Direct anterior and posterior restorations (including occlusal surfaces)
2) Base/liner under direct restorations
3) Core build-ups
4) Splinting
5) Indirect restorations including inlays, onlays and veneers
6) Restorations of deciduous teeth
7) Extended fissure sealing in molars and premolars
8) Repair of defects in porcelain restorations, enamel, and temporaries
Device Description
REVEAL Bulk is a light-activated restorative composite, optimized to allow for simpler and faster posterior restorations. REVEAL Bulk is intended to combine superior levels of handling, depth of cure, and polishability to perform as an optimum functional and aesthetic bulk fill composite.
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K Number
K162598Device Name
HAPI Seal
Manufacturer
BISCO, INC.
Date Cleared
2017-05-23
(246 days)
Product Code
EBC, CLA
Regulation Number
872.3765Why did this record match?
Applicant Name (Manufacturer) :
BISCO, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Pit and fissure sealant
Device Description
HAPI Seal is a light-cured, fluoride containing, resin-based pit & fissure sealant designed for sealing the enamel pits and fissures of teeth.
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K Number
K163171Device Name
CeraClean
Manufacturer
Bisco, Inc.
Date Cleared
2017-04-14
(151 days)
Product Code
PME
Regulation Number
872.3260Why did this record match?
Applicant Name (Manufacturer) :
Bisco, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CeraClean is an extraoral cleaner of pre-treated ceramic, zirconia and metal restoration surfaces which have been contaminated during intraoral try-in.
Device Description
CeraClean is used outside the mouth, as an extraoral cleaning gel suitable for non-abrasive cleaning of the bonding surfaces of prosthetic restorations after intraoral try-in. CeraClean is applied through a single-use tip or application to the prosthetic restorations and rinsed off prior to the application of a primer or cement for final placement of the restoration.
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K Number
K161051Device Name
All-Bond Universal w/BAC (not finalized)
Manufacturer
Bisco, Inc.
Date Cleared
2016-09-09
(148 days)
Product Code
KLE, CLA
Regulation Number
872.3200Why did this record match?
Applicant Name (Manufacturer) :
Bisco, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ALL-BOND UNIVERSAL w/BAC adhesive is used for:
1. all direct restorations
2. all indirect restorations
3. intra-oral repairs (i.e. repair of any fixed dental prosthesis containing zirconia, alumina, metals, glass ceramics, tooth structure, and composites)
4. desensitizing/sealing of tooth structure
5. protective varnish for glass ionomer fillings
6. priming of enamel for orthodontic use
Device Description
BISCO's ALL-BOND UNIVERSAL w/BAC is a light-cured single-component dental bonding agent that combines etching, priming, and bonding with benzalkonium chloride (BAC) in one bottle. ALL-BOND UNIVERSAL w/BAC is an ethanol/water-based dental adhesive which bonds to dentin and cut and un-cut enamel. ALL-BOND UNIVERSAL w/BAC has been designed to be fully compatible with light-cured and dual-cured composite materials. ALL-BOND UNIVERSAL w/BAC can be used for the bonding of both direct and indirect restorations. ALL-BOND UNIVERSAL w/BAC may be used with or without phosphoric acid etchant.
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K Number
K161256Device Name
TheraCem
Manufacturer
BISCO, INC.
Date Cleared
2016-07-29
(86 days)
Product Code
EMA, CLA, DAT
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
BISCO, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Use TheraCem to cement the following:
- 1. Metal crowns, bridges, inlays and onlays (includes porcelain-fused-to-metal and composite-to-metal)
- 2. Porcelain, Ceramic Crowns, inlays and onlays (includes alumina and zirconia)
- 3. Resin crowns, bridges, inlays and onlays (resin-based composite-ceramic hybrid)
- 4. Metal (prefabricated or cast) and non-metal/fiber endodontic posts
- 5. Implant supported restorations
- 6. Orthodontic Appliances (brackets, bands)
Device Description
TheraCem is a self-etching, self-adhesive, dual-cured resin luting cement that is exclusively formulated for luting crowns, bridges, inlays, onlays and posts (prefabricated metal and nonmetal/fiber posts, as well as cast posts). TheraCem is a paste/paste, fluoride- and calciumreleasing, luting cement which requires no etching, no priming or bonding of the prepared surfaces. It is easy-to use, requires only a short chair time, and produces a good bond to most dental materials. The cement is available in a Natural shade. It is radiopaque, allowing for easy identification on radiographs.
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K Number
K141439Device Name
ORTHODONTIC ACRYLIC (NOT FINALIZED)
Manufacturer
BISCO, INC.
Date Cleared
2014-09-12
(102 days)
Product Code
EBI
Regulation Number
872.3760Why did this record match?
Applicant Name (Manufacturer) :
BISCO, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Orthodontic Acrylic intended for the fabrication of methacrylate-based orthodontic appliances (such as retainers, bite guards, and bite plates, etc.).
Device Description
Orthodontic Acrylic is a fast curing self-cure 2-part system. The system consists of a powder and a liquid. The combination of the powder and liquid is converted into a hard methacrylate finished product.
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K Number
K131734Device Name
ALL-BOND UNIVERSAL SC (NOT FINALIZED)
Manufacturer
BISCO, INC.
Date Cleared
2014-04-11
(302 days)
Product Code
KLE, CLA
Regulation Number
872.3200Why did this record match?
Applicant Name (Manufacturer) :
BISCO, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
All-Bond Universal SC adhesive is used for:
- Direct Restorations (e.g. resin-based composite, resin-modified glass ionomer, core build-ups)
- Indirect Restorations (e.g. metal, glass, ceramics, zirconia/alumina)
- Bonding Resin or Primer for Substrates
- Desensitization/Sealing of Tooth
- Intraoral Repair (e.g. chipped porcelain, additions to direct restorations)
Device Description
All-Bond Universal SC is an auto-polymerizing adhesive with a light-curing alternative. It is designed for the dentist who prefers not to light cure the adhesive layer under indirect restorations. All-Bond Universal SC has a low film thickness (<5 µm). All-Bond Universal SC has a chemical formulation that allows the adhesive to be used in either self-etch or total-etch mode, based on the clinical situation and dentist preference. All-Bond Universal SC is compatible with light-cured, self-cured, dual-cured resin composite and cement base materials for direct and indirect procedures without any additional activators.
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