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510(k) Data Aggregation
K Number
K083652Device Name
IBOND TOTAL ETCH
Manufacturer
HERAEUS KULZER GMBH
Date Cleared
2009-01-21
(43 days)
Product Code
KLE
Regulation Number
872.3200Why did this record match?
Applicant Name (Manufacturer) :
HERAEUS KULZER GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- Bonding of direct composite, Polyglas® and compomer restorations .
- Bonding of indirect laboratory-fabricated ceramic, Polyglas and composite . restorations (inlays, onlays, veneers and crowns)
- 0 Treatment of hypersensitive tooth regions
Device Description
iBond Total Etch is an improved light-component adhesive for use in adhesive restorative dentistry and was developed within the scope of the project IBTE on the base of an ethanol solution of light-activated, adhesive resins The material is characterized by the following properties in detail
- The material has been developed for the adhesive bonding of plastic filling materials (e g ♥ composites, comporner, Polyglas ) to dental hard substance and laboratory-fabricated restorations (e g ceramics)
- With IBOND Total Etch, priming, bonding and desensitizing can be done in one step .
- Before using IBOND Total Etch, the dental hard substance is conditioned with iBOND Etch 35 Gel (etch&rinse)
In its unpolymenzed state, the adhesive matenal is workable smilar to current products Cross linking reaction is initiated with light curing (QTH, LED) devices customary in dental technology Cross-Iniking of the methacrylate monomers occurs very fast, ensurng reliable curing of the adheswe layer
Thus, a highly cross-linked material results, fully complying with the mechanical requirements for a dental adhesive matenal
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K Number
K080338Device Name
CUTTERSIL ACTIVATOR UNIVERSAL PLUS
Manufacturer
HERAEUS KULZER GMBH
Date Cleared
2008-04-21
(74 days)
Product Code
ELW, FLW
Regulation Number
872.3660Why did this record match?
Applicant Name (Manufacturer) :
HERAEUS KULZER GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CutterSil Activator Universal Plus paste and liquid are used as a catalyst to induce polymerization of the CutterSil base paste which is used for all inlay, crown and bridge, partial and edentulous impressions.
Device Description
Hardener Universal Plus (Liquid and Paste) (identical with Activator Universal Plus, Liquid and Paste) is the catalyst of the two component condensation curing silicone dental impression material Cuttersil (hardener and base paste and hardener are mixed before use according to the instruction of use.
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K Number
K073554Device Name
NEUN
Manufacturer
HERAEUS KULZER GMBH
Date Cleared
2008-02-04
(48 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
HERAEUS KULZER GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Direct restorations of Black classes I V. ●
Direct composite veneers .
Shape corrections of teeth .
Temporary splinting of teeth loosened by trauma or periodontal disease .
. Indirect restorations (inlays, veneers)
. Restoration of primary teeth
Core build-up .
Temporary repairs of composite and ceramics (in combination with a suitable . repair system)
Device Description
An improved light curing dental filling composite was developed within the scope of the project NEUN on the base of customary radical cross linking (meth)-acrylate monomers and dental glass fillers. The material is characterized by the following properties in detail:
- The material is a light curing nano hybride composite. .
- . The monomer matrix included is a particularly low-shrink mixture of polyether and urethane monomers preponderantly.
- A special TCD backbone monomer makes the excellent mechanical properties and the low . shrinkage possible. (TCD = tricyclodecane)
- . The composite material does not contain any Bis-GMA monomer making it toxicologically advantageous, as no Bisphenol-A can be released.
- The filler contained is a mixture of various particle size fractions of a customary, radiopaque dental . alass.
- The composite material contains non-agglomerated nano particles cross-linking to the polymer . network.
- . The material has a pasty consistency and can be applied plastically into the cavity. It is hardly sticky, packable, can be moulded, cured by blue light and polished with common systems.
- . Handling is comparable with customary light curing dental composite materials. For deeper cavities layering technique is recommended.
In its unpolymerized state, the composite material is plastically workable (pliable) similar to current products. Using a special initiator system reduced the sensitivity to ambient light. Cross-linking reaction is initiated with light curing devices (QTH, LED) customary in dental technology. Radical cross-linking of the (meth)- acrylate monomers occurs very fast, ensuring complete curing of a layer with a thickness of over 2 mm in an irradiation time of 20 seconds.
Thus, a highly cross-linked composite material results, fully complying with the mechanical requirements for a dental filling material in the Black classes I, II, III, IV and V according to the international standard EN ISO 4049.
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K Number
K062515Device Name
RETENTION FLOW OPAQUE
Manufacturer
HERAEUS KULZER GMBH
Date Cleared
2006-11-22
(86 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
HERAEUS KULZER GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Retention Flow Opaque is a light curing, transparent component for filling undercut areas in retentions.
Device Description
Not Found
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K Number
K050085Device Name
OSTEOPAL V
Manufacturer
HERAEUS KULZER GMBH
Date Cleared
2005-09-14
(244 days)
Product Code
LOD, NDN
Regulation Number
888.3027Why did this record match?
Applicant Name (Manufacturer) :
HERAEUS KULZER GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
OSTEOPAL® V bone cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a vertebroplasty or balloon kyphoplasty procedure.
Device Description
Osteopal® V is an acrylic cement for use in vertebroplasty and kyphoplasty. It is formed from powder and liquid by exothermic polymerization.
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K Number
K050854Device Name
PALACOS LV+G
Manufacturer
HERAEUS KULZER GMBH
Date Cleared
2005-07-07
(94 days)
Product Code
LOD
Regulation Number
888.3027Why did this record match?
Applicant Name (Manufacturer) :
HERAEUS KULZER GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PALACOS® LV + G is indicated for use in the second stage of a two stage revision for total joint arthroplasty after the initial infection has been cleared.
Device Description
Palacos® LV + G is an acrylic bone cement for use in orthopedic surgery. It is formed from powder and liquid by exothermic polymerization. It secures the fixation of the grafted artificial joint improving the transfer of forces at the interface implant - bone.
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K Number
K050855Device Name
PALAMED G
Manufacturer
HERAEUS KULZER GMBH
Date Cleared
2005-07-07
(94 days)
Product Code
LOD
Regulation Number
888.3027Why did this record match?
Applicant Name (Manufacturer) :
HERAEUS KULZER GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PALAMED® G is indicated for use in the second stage of a two stage revision for total joint arthroplasty after the initial infection has been cleared.
Device Description
PALAMED® G is an acrylic bone cement for use in orthopedic surgery. It is formed from powder and liquid by exothermic polymerization. It secures the fixation of the grafted artificial joint improving the transfer of forces at the interface implant - bone.
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K Number
K051006Device Name
IBOND NEXT GENERATION
Manufacturer
HERAEUS KULZER GMBH
Date Cleared
2005-06-07
(48 days)
Product Code
KLE
Regulation Number
872.3200Why did this record match?
Applicant Name (Manufacturer) :
HERAEUS KULZER GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- Bonding of direct composite restorations (including Polyglas® and Compomer)
- Bonding of direct composite restoration with a light-curing luting cement:
- Bonding of indirect restoration in combination with a light-curing luting cement: Porcelain, Polyglas®, and composite restorations (inlays, onlays, veneers, crowns).
- Sealing hypersensitive areas of teeth.
Device Description
Not Found
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K Number
K042199Device Name
TRANSLUX POWER BLUE
Manufacturer
HERAEUS KULZER GMBH
Date Cleared
2004-09-08
(26 days)
Product Code
EBZ
Regulation Number
872.6070Why did this record match?
Applicant Name (Manufacturer) :
HERAEUS KULZER GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Activator for light-induced intraoral polymerization of resin dental pit and fissure sealant, restorative materials, bonding , or luting materials.
Device Description
Not Found
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K Number
K031673Device Name
REFOBACIN -PALACOS G
Manufacturer
HERAEUS KULZER GMBH & CO. KG
Date Cleared
2004-05-25
(361 days)
Product Code
LOD
Regulation Number
888.3027Why did this record match?
Applicant Name (Manufacturer) :
HERAEUS KULZER GMBH & CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PALACOS G is indicated for use in the second stage of a two stage revision for total joint arthroplasty after the initial infection has been cleared.
Device Description
Palacos® G is an acrylic bone cement for use in orthopedic surgery. It is formed from powder and liquid by exothermic polymerization. It secures the fixation of the grafted artificial joint improving the transfer of forces at the interface implant - bone.
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