Ecosite Elements
- Primary DI
- EDMG2208011
- Brand
- Ecosite Elements
- Company
- DMG Chemisch-Pharmazeutische Fabrik GmbH
- Model
- 220801
- Catalog number
- 220801
- Device description
- 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
- Published
- 2019-09-06
- Public version status
- Update
- Distribution status
- Not in Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Contact Domains#
Product Codes#
| Code | Name |
|---|---|
| EBF | Material, Tooth Shade, Resin |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | Dental | 2 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| EDMG2208011 | Primary | HIBCC | 0 | |
| EDMG2208010 | Unit of Use | HIBCC | 0 |
GMDN Terms#
| Term | Definition |
|---|---|
| Dental composite resin | A 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 | Condition |
|---|---|---|---|
| Storage Environment Temperature | 0 | 0 |
Contacts#
| Phone | |
|---|---|
| 201-894-5505 | eanagnostos@dmg-america.com |
Regulatory Flags#
- DUNS number
- 320744915
- Device count
- 5
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- true
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| EDMG2133201 | TECO | 213320 | 213320 | 2016-09-22 |
| EDMG2208021 | Ecosite Elements | 220802 | 220802 | 2019-09-06 |
| EDMG2208031 | Ecosite Elements | 220803 | 220803 | 2019-09-06 |
| EDMG2208051 | Ecosite Elements | 220805 | 220805 | 2019-09-06 |
| EDMG2208061 | Ecosite Elements | 220806 | 220806 | 2019-09-06 |
| EDMG2225541 | Flairesse Bleaching Gel CP 16% Starter Pack | 222554 | 2026-09-01 | |
| EDMG2225551 | Flairesse Bleaching Gel CP 16% Refill | 222555 | 2026-09-01 | |
| EDMG1103600 | Luxatemp® Automix Solar | 110360 | 110360 | 2016-09-21 |
| EDMG1103680 | Luxatemp® Automix Plus | 110368 | 110368 | 2016-09-21 |
| EDMG1104000 | Luxatemp® Automix Plus | 110400 | 110400 | 2016-09-21 |
| EDMG1104010 | Luxatemp® Automix Plus | 110401 | 110401 | 2016-09-21 |
| EDMG1104020 | Luxatemp® Automix Plus | 110402 | 110402 | 2016-09-21 |
| EDMG1104030 | Luxatemp® Automix Plus | 110403 | 110403 | 2016-09-21 |
| EDMG1104040 | Luxatemp® Automix Plus | 110404 | 110404 | 2016-09-21 |
| EDMG1104060 | Luxatemp® Automix Plus | 110406 | 110406 | 2016-09-21 |
| EDMG1105850 | Luxatemp® Fluorescence | 110585 | 110585 | 2016-09-21 |
| EDMG1105860 | Luxatemp® Fluorescence | 110586 | 110586 | 2016-09-21 |
| EDMG1105870 | Luxatemp® Fluorescence | 110587 | 110587 | 2016-09-21 |
| EDMG1105880 | Luxatemp® Fluorescence | 110588 | 110588 | 2016-09-21 |
| EDMG1105890 | Luxatemp® Fluorescence | 110589 | 110589 | 2016-09-21 |
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