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510(k) Data Aggregation
K Number
K191385Device Name
BRILLIANT COMPONEER
Manufacturer
Date Cleared
2019-10-29
(159 days)
Product Code
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
Coltene/Whaledent AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Clinical indications
- Restoration of caries defects
- Reconstruction of lost tooth substance due to attrition, abrasion, erosion
- Restoration of tooth fractures
- Correction of anatomical malformation
Cosmetic indications
- Optimization of old composite restorations
- Extending incisors
- Correction of malpositioned teeth
- Cosmetic corrections for tooth discoloration or incorrect shading
- Closure of diastema
Device Description
The subject device BRILLIANT COMPONEER is a polymerized, highly filled, submicron hybrid composite enamel shell(s) for direct veneering. It simplifies the direct restoration of front teeth and premolars without having to model the basic shape of the top enamel layer. The thin, anatomical composite shells are available in different shades and shapes allowing a natural, high aesthetic restoration.
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K Number
K190597Device Name
BRILLIANT EverGlow Flow
Manufacturer
Date Cleared
2019-06-21
(106 days)
Product Code
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
Coltene/Whaledent AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
BRILLIANT EverGlow Flow Universal and Translucent shades are suitable for:
- · Direct class V fillings (cervical caries, root erosion, wedge-shaped defects)
- · Fillings in the anterior tooth region (Class III and IV)
- · Small fillings of all cavity classes (not occlusion-bearing)
- · Blocking out of undercuts
- · Adhesive luting of indirect composite and ceramic restorations in as far as accuracy of fit and light permeability are given
- · Repairs of direct and indirect composite restorations
- · Preventive resin restorations
- · Cavity lining
BRILLIANT EverGlow Flow opaque shade is also suitable for:
- · Aesthetic corrections (e.g. deviations in chroma)
- · Masking of dark areas
Device Description
BRILLIANT EverGlow Flow is a flowable radiopaque submicron hybrid composite and available in several shades that allows for high aesthetic restorations with a clear spectrum of shades. It is applied in the increment technique and available in 7 universal, 2 translucent and 3 opaque shades.
BRILLIANT EverGlow Flow is chemically characterized by its composition, which can be categorized in three groups based on their chemical and functional similarity: resin components (matrix monomers based on methacrylates), fillers, and additives. The largest part of BRILLIANT EverGlow Flow's composition is represented by fillers (>58% w/w), followed by resin components (<40% w/w), and additives (<2% w/w). BRILLIANT EverGlow Flow is, after curing, a crosslinked methacrylate-based composite material with a three-dimensional polymer network, containing embedded filler particles and incorporated additives.
BRILLIANT EverGlow Flow has long term contact (>30 days) with tissue/bone/dentin.
BRILLIANT EverGlow Flow is the supplemental flowable, radiopaque submicron hybrid material version of the universal composite BRILLIANT EverGlow. BRILLIANT EverGlow Flow is, due to its lower viscosity, considered an enhancement of BRILLIANT EverGlow for applications with non-easily accessible areas in the oral cavity (e.g. blocking out of undercuts) and/or extended fissure-sealing. BRILLIANT EverGlow Flow combines a low viscous consistency with high stability and thixotropy, allowing a controlled and comfortable application. BRILLIANT EverGlow Flow is available in different shades and gradations of translucency. BRILLIANT EverGlow Flow is delivered with two application needle sizes (standard size [Ø 0.8mm] and fine size [Ø 0.4mm]). The fine size needle is to improve the accessory range and to allow an application with higher precision.
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K Number
K181500Device Name
BRILLIANT Crios
Manufacturer
Date Cleared
2018-08-15
(69 days)
Product Code
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
Coltene/Whaledent AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
BRILLIANT Crios is indicated for:
- Crowns, inlays, onlays and veneers
- Implant-supported crowns.
Device Description
BRILLIANT Crios is a radiopaque composite material composed of crosslinked methacrylate based polymerized monomers and dental glass fillers. The subject device is made available in block forms of different sizes, shades and translucencies for the fabrication of permanent tooth restorations such as inlays, onlays, crowns and veneers using CAD/CAM milling equipment.
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K Number
K160800Device Name
DuoCem
Manufacturer
Date Cleared
2016-11-16
(238 days)
Product Code
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
COLTENE/WHALEDENT AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
DuoCem is indicated for:
- permanent cementing of crowns, inlays, onlays (ceramic, metal, composite)
- permanent cementing of root posts of all types
Device Description
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K Number
K152927Device Name
BRILLIANT EVERGLOW
Manufacturer
Date Cleared
2016-04-28
(206 days)
Product Code
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
COLTENE/WHALEDENT AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
BRILLIANT EverGlow Bleach (BL), A1/B1, A2/B2, A3/D3, A3,5/B3, C2/C3, A4/C4 are indicated for:
- Direct filling of class I, II, III, IV and V cavities
- Cementation and repair of composite and ceramic restorations (e.g. COMPONEER)
BRILLIANT EverGlow Translucent (Trans) and Bleach Translucent (BL Trans) are indicated for:
- Shape and color corrections to enhance the individual esthetics
- Reconstruction of incisal edges
- Cementation and repair of composite and ceramic restorations (e.g. COMPONEER)
Device Description
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K Number
K152243Device Name
One Coat 7 Universal
Manufacturer
Date Cleared
2015-12-09
(121 days)
Product Code
Regulation Number
872.3200Why did this record match?
Applicant Name (Manufacturer) :
Coltene/Whaledent AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
One Coat 7 Universal is indicated for:
- bonding in adhesive restoration techniques
- adhesive attachment of composite materials and compomers on enamel and dentin
- adhesive attachment of ceramic and composite restorations on enamel and dentine
- composite material on ceramic, composite material, metal and amalgam
- dentine sealing
Device Description
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K Number
K150218Device Name
Fill-Up!
Manufacturer
Date Cleared
2015-06-23
(144 days)
Product Code
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
COLTENE/WHALEDENT AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Fill-Up! is indicated for - direct restoration of class I and II cavities - cavity lining - first layer for class I and II cavities - core build-ups
Device Description
Not Found
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K Number
K130137Device Name
BIOSONIC SUVI PIEZEOELECTRIC SCALER AND POLISHER
Manufacturer
Date Cleared
2013-08-23
(217 days)
Regulation Number
872.4850Why did this record match?
Applicant Name (Manufacturer) :
COLTENE/WHALEDENT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The BioSonic Suvi ultrasonic scaler is intended for use in dental applications such as supra and subgingival scaling, periodontal therapy, endodontic procedures, cavity preparation, and restorative dentistry.
The BioSonic Suvi Air Polisher is intended for use in the cleaning, surface preparation and polishing of teeth by the projection of water, air and dental powders onto the tooth surface. The device removes dental plaque, soft deposits, and surface stains from pits, grooves, interproximal spaces or smooth surfaces of teeth. The BioSonic Suvi Air Polisher is also indicated for the nonsurgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment.
Device Description
The BioSonic Suvi Piezoelectric Scaler and Air Polisher (BioSonic Suvi) is a combination scaler and polisher device for use in dental care. It combines the functions of an ultrasonic scaler and dental air polisher into a single device.
The scaler is used for removal of tartar or calculus on teeth and other dental work where ultrasonic vibration is beneficial. The polisher unit is used for removal of plaque, cleaning discolored teeth and other dental work where air polishing is beneficial.
The BioSonic Suyi will be offered in (4) four different models. These are the BioSonic Suvi Premier, BioSonic Suvi Premier Plus, BioSonic Suvi Elite and the BioSonic Suvi Elite Plus. The Premier and Premier Plus are scalers only. The Elite and Elite Plus are combination scaler and polisher units
The Premier and Plus versions differ in whether they include a standard tap water supply attachment or an optional medicament dispenser system. The standard tap water versions connect directly to a tap water supply using a hose connection. The medicament dispenser system provides either medicine or clean water using a medicament bottle which connects to the side of the unit.
The medicament versions utilize an internal air compressor to pressurize the medicament. During use, compressed air forces fluids from the bottle, through the hose, to the hand piece and the tip/nozzle. Thus medication can be provided if desired.
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K Number
K121621Device Name
SOLOCEM
Manufacturer
Date Cleared
2013-01-08
(221 days)
Product Code
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
COLTENE/WHALEDENT AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
SoloCem is indicated for
- permanent cementation of root posts of all types
- permanent cementation of crowns, bridges, inlays, onlays
- permanent cementation of implant abutments
Device Description
Not Found
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K Number
K112168Device Name
COMPONEER
Manufacturer
Date Cleared
2011-11-21
(116 days)
Product Code
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
COLTENE/WHALEDENT AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
- -restoration therapy for caries
- -optimisation of old restorations
- -tooth fractures
- -extending incisors
- -malpositioned teeth
- -tooth discoloration, incorrect shading
- -anatomical malformation
- -diasteme
- -attrition, abrasion, erosion
- -cosmetic correction
Device Description
COMPONEER are polymerised, radio-opaque composite shells
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