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510(k) Data Aggregation
K Number
K103474Device Name
ENA TEMP AND ENAMEL PLUS TEMP (TWO DIFFERENT PROPRIETARY NAMES FOR THE SAME PRODUCT)
Manufacturer
MICERIUM S.P.A.
Date Cleared
2011-02-07
(73 days)
Product Code
EBG
Regulation Number
872.3770Why did this record match?
Applicant Name (Manufacturer) :
MICERIUM S.P.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ENA TEMP/ ENAMEL PLUS TEMP is a system of liquid and powder resin available in different colours, for aesthetic temporary crown and bridge. It can be used both in laboratory (by indirect method: diagnostic waxing up or vacuum forming matrix) and in dental practice (by direct method in the mouth: silicone impression or preformed crown).
Device Description
ENA TEMP/ ENAMEL PLUS TEMP is a system of liquid and powder resin available in different colours, for aesthetic temporary crown and bridge. It can be used both in laboratory (by indirect method: diagnostic waxing up or vacuum forming matrix) and in dental practice (by direct method in the mouth: silicone impression or preformed crown). Please note that the resin is absolutely the same, but they will be sold with two different brand names for commercial reasons. So, in order to simplify, from here on they will be denoted as "Temp"
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K Number
K072978Device Name
TENDER ORTHO BOND-ENA BOND-ENA ETCH
Manufacturer
MICERIUM S.P.A.
Date Cleared
2008-01-17
(87 days)
Product Code
DYH
Regulation Number
872.3750Why did this record match?
Applicant Name (Manufacturer) :
MICERIUM S.P.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Adhesive for luting ceramic and metal orthodontic brackets
Device Description
Adhesive system, light curable both with halogen and LED Light, for brackets cementation. The accessories contact tissue for less than 1 hour and therefore are exempt from 510(k) requirements and are described only generally.
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K Number
K063170Device Name
TENDER FIBER
Manufacturer
MICERIUM S.P.A.
Date Cleared
2007-01-12
(86 days)
Product Code
EBI
Regulation Number
872.3760Why did this record match?
Applicant Name (Manufacturer) :
MICERIUM S.P.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Tender fiber is a semi-manufactured product made of fibers used to reinforce composite and acrylic prosthodontic appliances and to repair or reinforce denture and rethodontic appliances. It can be use as well to immobilize teeth for periodontic or orthodontic treatments.
Device Description
Tender Fiber are silanized glass fibers, impregnated with light curing resin used to reinforce prosthodontic appliances and to repair or reinforce denture and orthodontic appliances.
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K Number
K062355Device Name
ENA CEM
Manufacturer
MICERIUM S.P.A.
Date Cleared
2006-12-27
(135 days)
Product Code
EMA
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
MICERIUM S.P.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
EnaCem is a dual curing radiopaque fluorescent luting composite, available in several dentine colours, for cementation of posts, ceramic and composite inlay, onlay veneers and crowns. It can be used also for core build-up and as a liner.
Device Description
The ENA CEM is a luting material available in a flowable consistency (Ena Cem) and also in a high viscous version (Ena Cem HF) that is available in different colours. Both can be used for cementing prosthesis appliances made in laboratory to the tooth. They can be used also for post-cementation. Ena Cem HF can also be used for core build-up and as a liner. The accessories and try-in materials contact tissue for less than 1 hour and therefore are exempt from 510(k) requirements and are described only generally.
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K Number
K062367Device Name
MINISCREWS ANCHORING SYSTEM, M.A.S.
Manufacturer
MICERIUM S.P.A.
Date Cleared
2006-12-08
(116 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
MICERIUM S.P.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for single use only on adults over the age of 12.
Device Description
This device is an endosseous dental implant consisting of the major component, of root-form, screw type, and the accessories, designed to facilitate placing and using the implant in orthodontic procedures. The accessories contact tissue for less than 1 hour and therefore are exempt from 510(k) requirements and are described only generally. The smoothly curved head has a groove in the middle for the attachment of elastics, chains, or coil springs commonly used in orthodontics. The head (groove) has a aperture where a wire or auxiliary can be attached. The rounded head of the implant has an internal hexagon for insertion of the screw driver. The MAS implant is made from Group V titanium.
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K Number
K062906Device Name
ENA HFO COMPOSITE SYSTEM
Manufacturer
MICERIUM S.P.A.
Date Cleared
2006-11-17
(51 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
MICERIUM S.P.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ENA HFO is a composite system for direct and indirect aesthetic restorations in anterior and posterior sectors.
Device Description
ENA HFO is a system for direct and indirect aesthetic restorations in anterior and posterior sectors, composed by a light curing radiopaque composite, available in different colors, with accessories for application and polishing. The accessories contact tissue for less than 1 hour and therefore are exempt from 510(k) requirements and are described only generally.
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