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510(k) Data Aggregation
K Number
K240823Device Name
els extra low shrinkage® composite & els extra low shrinkage® flow
Manufacturer
Saremco Dental AG
Date Cleared
2024-06-27
(93 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
Saremco Dental AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
els extra low shrinkage® composite & els extra low shrinkage® flow are restorative materials intended for the reconstruction or correction of natural dentition.
els extra low shrinkage® composite is indicated for:
- Restoration of class I, II, III, IV and V cavities on anterior and posterior teeth
- Indirect anterior and posterior restorations including inlays, onlays and veneers
- Aesthetic corrections of interdental spaces, enamel hypoplasia, discolorations
- Splinting
els extra low shrinkage® flow is indicated for:
- Restorations with minimally invasive preparation technique
- Restorations of small cavities and extended fissure sealing
- Alternate restorations for undercut cavities
- Restorations of class III V including wedged shaped defects and cervical caries
- Repair of fillings, veneers and methacrylate-based temporary restorations
- First layer of fillings for Class I and II
- Interlocking of loosened teeth
- Adhesive attachment of indirect composite and ceramic restorations
Device Description
els extra low shrinkage® composite is classified as a Type 1, Class 2, Group 1 & 2 Polymerbased restorative material according to ISO 4049:2009 - Dentistry - Polymer-based restorative materials.
els extra low shrinkage® flow is classified as Type 2, Class 2, Group 1 Polymer-based restorative material according to ISO 4049:2009 – Dentistry – Polymer-based restorative materials.
els extra low shrinkage® composite & els extra low shrinkage® flow are light-cured methacrylate-based resins that are intended to fill and restore small to large defects or carious lesions in teeth.
els extra low shrinkage® composite & els extra low shrinkage® flow are light cured radiopaque microhybrid composites with extremely low shrinkage stress.
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K Number
K232050Device Name
saremco print BRIDGETEC
Manufacturer
Saremco Dental AG
Date Cleared
2023-11-14
(127 days)
Product Code
EBF, EBG, PZY
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
Saremco Dental AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
saremco print BRIDGETEC is a light-curing 3D-printed material intended as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The saremco print BRIDGETEC material is used for fabricating permanent restorations such as inlays, onlays, veneers, full crown and 3-part bridge restorations. saremco print BRIDGETEC can also be used for the fabrication of artificial teeth and temporary crowns & bridges.
Device Description
saremco print BRIDGETEC is a resin-based material for the production of permanent and temporary restorations, veneers and artificial teeth on 3D printers. The material is an alternative to traditional heat-cured and auto polymerization resins. It requires a computer-aided and manufacturing (CAD/CAM) system including scanner, design software, additive printer and a post-curing unit.
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K Number
K213343Device Name
Saremco Print CROWNTEC
Manufacturer
Saremco Dental AG
Date Cleared
2022-01-21
(106 days)
Product Code
EBF, EBG, PZY
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
Saremco Dental AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
saremco print CROWNTEC is a light-curing 3D-printed material intended as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The saremco print CROWNTEC material is used for fabricating permanent restorations such as inlays, onlays, veneers and full crown restorations. saremco print CROWNTEC can also be used for the fabrication of artificial teeth and temporary crowns & bridges.
Device Description
saremco print CROWNTEC is a resin-based material for the production of permanent and temporary restorations, veneers and artificial teeth on 3D printers. The material is an alternative to traditional heat-cured and auto polymerization resins. It requires a computer-aided and manufacturing (CAD/CAM) system including scanner, design software, additive printer and a post-curing unit.
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