Ecosite Elements 220803

GUDID EDMG2208031

Ecosite Elements is a light-curing, esthetic, radiopaque nanohybrid composite system for the anterior 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, Enamel Medium = EM and Enamel Dark = ED) in different opacities. This, combined with their unique handling and excellent polishing properties contributes to the creation of highly-aesthetic restorations. The shades OA2 (Opak A2) and INC (Incisal) are radiopaque composites with optimum flow composites. The shade OA2 is recommended for the veneering of slightly discolored areas and for creating ultimate tooth opacity. The shade INC is particularly suitable for an esthetic incisal edge 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 composite restorations. The shade W is used for the reproduction of white spots and as an oqaque covering layer. The shade B is an ideal choice for fissures and the replication of brown spots. Module – Highlight set: 4 Syringes @ 2 g in the shades INC, OA2, W, B

DMG Chemisch-Pharmazeutische Fabrik GmbH

Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin
Primary Device IDEDMG2208031
NIH Device Record Key6cd0e671-33ee-4272-bcb1-abd7862a8934
Commercial Distribution StatusIn Commercial Distribution
Brand NameEcosite Elements
Version Model Number220803
Catalog Number220803
Company DUNS320744915
Company NameDMG Chemisch-Pharmazeutische Fabrik GmbH
Device Count4
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone201-894-5505
Emaileanagnostos@dmg-america.com
Phone201-894-5505
Emaileanagnostos@dmg-america.com
Phone201-894-5505
Emaileanagnostos@dmg-america.com
Phone201-894-5505
Emaileanagnostos@dmg-america.com
Phone201-894-5505
Emaileanagnostos@dmg-america.com
Phone201-894-5505
Emaileanagnostos@dmg-america.com
Phone201-894-5505
Emaileanagnostos@dmg-america.com
Phone201-894-5505
Emaileanagnostos@dmg-america.com
Phone201-894-5505
Emaileanagnostos@dmg-america.com
Phone201-894-5505
Emaileanagnostos@dmg-america.com
Phone201-894-5505
Emaileanagnostos@dmg-america.com
Phone201-894-5505
Emaileanagnostos@dmg-america.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEDMG2208030 [Unit of Use]
HIBCCEDMG2208031 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBFMaterial, Tooth Shade, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-09-16
Device Publish Date2019-09-06

On-Brand Devices [Ecosite Elements]

EDMG2208061Ecosite Elements is a light-curing, esthetic, radiopaque nanohybrid composite system for the ant
EDMG2208051Ecosite Elements is a light-curing, esthetic, radiopaque nanohybrid composite system for the ant
EDMG2208031Ecosite Elements is a light-curing, esthetic, radiopaque nanohybrid composite system for the ant
EDMG2208021Ecosite Elements is a light-curing, esthetic, radiopaque nanohybrid composite system for the ant
EDMG2208011Ecosite Elements is a light-curing, esthetic, radiopaque nanohybrid composite system for the ant

Trademark Results [Ecosite Elements]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ECOSITE ELEMENTS
ECOSITE ELEMENTS
79270462 not registered Live/Pending
Mühlbauer Technology GmbH
2019-08-15

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