Ecosite Elements 220801

GUDID EDMG2208011

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 – Pure Set: 5 Syringes @ 4 g in the shades B1, A2, A3, A3.5, A4 1 bottle @ 5 ml Ecosite-Bond

DMG Chemisch-Pharmazeutische Fabrik GmbH

Dental composite resin

• Primary Device ID: EDMG2208011
• NIH Device Record Key: 478d06be-d9e6-4877-b8fb-96e1cff5e4b1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ecosite Elements
• Version Model Number: 220801
• Catalog Number: 220801
• Company DUNS: 320744915
• Company Name: DMG Chemisch-Pharmazeutische Fabrik GmbH
• Device Count: 5
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EDMG2208010 [Unit of Use]
HIBCC	EDMG2208011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080480

FDA Product Code

• EBF: Material, Tooth Shade, Resin

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-09-16
• Device Publish Date: 2019-09-06

On-Brand Devices [Ecosite Elements]

• EDMG2208061: Ecosite Elements is a light-curing, esthetic, radiopaque nanohybrid composite system for the ant
• EDMG2208051: Ecosite Elements is a light-curing, esthetic, radiopaque nanohybrid composite system for the ant
• EDMG2208031: Ecosite Elements is a light-curing, esthetic, radiopaque nanohybrid composite system for the ant
• EDMG2208021: Ecosite Elements is a light-curing, esthetic, radiopaque nanohybrid composite system for the ant
• EDMG2208011: Ecosite Elements is a light-curing, esthetic, radiopaque nanohybrid composite system for the ant