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510(k) Data Aggregation
K Number
K201010Device Name
Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite
Manufacturer
Nobio Ltd.
Date Cleared
2020-08-14
(119 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
Nobio Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Infinix™ Universal Composite:
- Restorations in the posterior region (Class I and II)
- Anterior restorations (Class III, IV)
- Class V restorations (cervical caries, root erosion, wedge-shaped defects)
- Veneering of discolored anterior teeth
- Splinting of mobile teeth
- Extended fissure sealing in molars and premolars
- Repair of composite/ceramic veneers
The addition of the QASi particles to the Infinix™ Universal Composite reduces demineralization, which is part of the caries-formation process.
Infinix™ Flowable Composite:
- Class III and V restorations
- Restoration of minimally invasive cavity preparations (including small, non-stress-bearing occlusal restorations)
- As base/liner under direct or indirect restorations
- Repair of small defects in aesthetic indirect restorations
- Pit and fissure sealant
- Blocking out of undercuts
- Repair of resin and acrylic temporary materials
The addition of the QASi particles to the Infinix™ Flowable Composite reduces demineralization, which is part of the caries-formation process.
Infinix™ Bulk Fill Flow Composite:
- Base under Class I and II direct restorations
- Liner under direct restorative materials
- Pit and fissure sealant
- Restoration of minimally invasive cavity preparations (including small, non-stress-bearing occlusal restorations)
- Class III and V restorations
- Blocking out of undercuts
- Repair of small enamel defects
- Repair of small defects in esthetic indirect restorations
- Repair of resin and acrylic temporary materials
- As a core build-up where at least half the coronal tooth structure is remaining to provide structural support for the crown
The addition of the OASi particles to the Infinix™ Bulk Fill Flow Composite reduces demineralization, which is part of the caries-formation process.
Device Description
The Infinix™ Family of Dental Composites include the following light-cured, resinbased composite materials:
- Universal Composite
- Flowable Composite
- Bulk Fill Flow Composite
Some of the silica-based filler particles (max 1.2% wt/wt of the total formulation) contained in all the Infinix™ composites are decorated with quaternary ammonium functional groups that are covalently bound to the filler particles' silica core via a silane linker (herein referred to as "QASi"). Following light induced polymerization, QASi particles (produced by Nobio) remain permanently entrapped within the composite restoration and destroy microorganisms by contact. As the cell membrane of microorganisms is negatively charged and the QASi particles have strong positive charges, microorganisms are electrostatically attracted to the positively charged cured material's surface resulting in disruption of their cell membrane and immediate microbial lysis.
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K Number
K183391Device Name
Novidia Universal Bond
Manufacturer
Nobio Ltd.
Date Cleared
2019-09-24
(291 days)
Product Code
KLE
Regulation Number
872.3200Why did this record match?
Applicant Name (Manufacturer) :
Nobio Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Novidia Universal Bond is indicated for:
- 1) Direct restorations using light-cured composite resin or compomer
- 2) Cavity sealing as a pretreatment for indirect restorations
- 3) Treatment of hypersensitive teeth and/or exposed root surfaces
- 4) Intraoral repairs of fractured crowns/bridges made of porcelain, hybrid ceramics, or composite resin using light-cured composite resin
- 5) Surface treatment of prosthetic appliances made of porcelain, hybrid ceramics, or cured composite resin
- 6) Core build-ups using light- or dual-cured composite resin
- 7) Cavity sealing under amalgam restorations
* For indications 1, 2, 3, 6, and 7 the device exhibits an antibacterial cavity cleansing effect.
Device Description
Novidia™ Universal Bond is a resin-based bond system consisting of a self-etch primer and a light-cured bond. It is designed to enhance penetration into prepared enamel and dentin surfaces and to establish strong adhesion between mineralized dental surfaces and the restorative materials such as resin composites, resin cements, metals, and ceramics (e.g., porcelain, lithium disilicate, zirconia, or hybrid ceramics) restorations. The chemical composition of the Universal Bond's primer consists of adhesion promoter and solvent, and the Universal Bond consists of resin, solvent, initiators and antibacterial insoluble particles, which contain covalently bound quaternary ammonium (QA).
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K Number
K182921Device Name
Infinix Universal Composite
Manufacturer
Nobio Ltd.
Date Cleared
2019-09-13
(329 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
Nobio Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The InfinixTM Universal Composite is indicated for:
- · Restorations in the posterior region (Class I and II)
- · Anterior restorations (Class III, IV)
- · Class V restorations (cervical caries, root erosion, wedge-shaped defects)
- · Veneering of discolored anterior teeth
- · Splinting of mobile teeth
- · Extended fissure sealing in molars and premolars
- · Repair of composite/ceramic veneers
Device Description
Infinix™ Universal Composite is a packable (high viscosity) dental composite filling material, intended for direct anterior and posterior restorations, class V restorations, veneering of discolored anterior teeth, and repair of composite/ceramic veneers. The resin matrix of the Infinix™ Universal Composite contains Urethane dimethacrylate (UDMA), Bisphenol-a glycidyl dimethacrylate (Bis-GMA) and triethylene glycol dimethacrylate (TEGDMA). The inorganic filler of the Infinix™ Universal Composite is a mix of particles of alumino-silicate-based glasses, silica dioxide and pigments. A small percentage of the silica-based filler particles are covalently bound to quaternary ammonium residues (OASi), added to maintain the integrity of the restoration. The Infinix™ Universal Composite is provided in syringes (4 g) and in single-dose capsules (0.2 g) and is available in five shades (A1, A2, A3, B1 and translucent).
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K Number
K182714Device Name
Novidia Bulk Fill Flow Composite
Manufacturer
Nobio Ltd.
Date Cleared
2019-07-12
(288 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
Nobio Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Novidia™ Bulk Fill Flow Composite is indicated for:
- 1. Base under Class I and II direct restorations
- 2. Liner under direct restorative materials
- 3. Pit and fissure sealant
- 4. Restoration of minimally invasive cavity preparations (including small, non-stress-bearing occlusal restorations)
- 5. Class III and V restorations
- 6. Blocking out of undercuts
- 7. Repair of small enamel defects
- 8. Repair of small defects in esthetic indirect restorations
- 9. Repair of resin and acrylic temporary materials
10. As a core build-up where at least half the coronal tooth structure is remaining to provide structural support for the crown
Device Description
Novidia™ Bulk Fill Flow Composite is a low viscosity, visible-light activated, radiopaque, flowable composite indicated for minimally invasive cavity preparations as well as various other indications. The resin matrix of the Novidia™ Bulk Fill Flow Composite contains Urethane dimethacrylate (UDMA), Bisphenol-a glycidyl dimethacrylate (Bis-GMA) and triethylene glycol dimethacrylate (TEGDMA). The inorganic filler of the Novidia™ Bulk Fill Flow Composite is a mix of particles of alumino-silicate-based glasses, silica dioxide and pigments. A small percentage of the silica-based filler particles are covalently bound to quaternary ammonium residues (QASi), added to maintain the integrity of the restoration. The Novidia™ Bulk Fill Flow Composite is provided in syringes (2 g) and in single-dose capsules (0.2 g) and is available in two shades (A2 and A3).
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K Number
K182580Device Name
Novidia Flowable Composite
Manufacturer
Nobio Ltd.
Date Cleared
2019-07-03
(287 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
Nobio Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Novidia™ Flowable Composite is indicated for:
1. Class III and V restorations
2. Restoration of minimally invasive cavity preparations (including small, non-stress bearing occlusal restorations)
3. As base/liner under direct or indirect restorations
4. Repair of small defects in esthetic indirect restorations
5. Pit and fissure sealing
6. Blocking out of undercuts
7. Repair of resin and acrylic temporary materials
Device Description
Novidia™ Flowable Composite is a low viscosity, visible light activated, radiopaque, flowable composite indicated for minimally invasive cavity preparations as well as various other indications. The resin matrix of the Novidia™ Flowable Composite contains Urethane dimethacrylate (UDMA), Bisphenol-a glycidyl dimethacrylate (Bis-GMA) and triethylene glycol dimethacrylate (TEGDMA). The inorganic filler of the Novidia™ Flowable Composite is a mix of particles of alumino-silicate-based glasses, silica dioxide and pigments. A small percentage of the silica-based filler particles are covalently bound to quaternary ammonium residues (OASi), added to maintain the integrity of the restoration. The Novidia™ Flowable Composite is provided in syringes (2 g) and in single-dose capsules (0.2 g) and is available in three shades (A1, A2 and A3).
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