Ecosite Elements

Primary DI
EDMG2208021
Brand
Ecosite Elements
Company
DMG Chemisch-Pharmazeutische Fabrik GmbH
Model
220802
Catalog number
220802
Device description
Ecosite Elements is a light-curing, esthetic, radiopaque nanohybrid composite system for theanterior and posterior region. The range of highly viscous composites includes 5 VITA shades(B1, A2, A3, A3.5 and A4) and 4 enamel shades (Enamel Bleach = EB, Enamel Light = EL, EnamelMedium = EM and Enamel Dark = ED) in different opacities. This, combined with their uniquehandling and excellent polishing properties contributes to the creation of highly-aestheticrestorations.The shades OA2 (Opak A2) and INC (Incisal) are radiopaque composites with optimum flowcomposites. The shade OA2 is recommended for the veneering of slightly discolored areas andfor creating ultimate tooth opacity. The shade INC is particularly suitable for an esthetic incisaledge design thanks to its high transparency. Both shades are suitable for fissure sealing.The shades W (White) and B (Brown) are flowable composites for the customization of compositerestorations. The shade W is used for the reproduction of white spots and as an oqaque coveringlayer. The shade B is an ideal choice for fissures and the replication of brown spots. 4 Syringes @ 4 g in the shades EB, EL, EM, ED
Published
2019-09-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBFMaterial, Tooth Shade, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K080480000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080480000NANOCOMPOSITE RESTORATIVE KITDmg USA, Inc.2008-05-30EBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EDMG2208021PrimaryHIBCC0
EDMG2208020Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental composite resinA non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature36 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
201-894-5505eanagnostos@dmg-america.com

Regulatory Flags#

DUNS number
320744915
Device count
4
Lot or batch
true
Serial number
true
Expiration date on label
true

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