Duns Number:320744915
Device Description: Ecosite Elements is a light-curing, esthetic, radiopaque nanohybrid composite system for t 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. Module – Layer set: 64 Safetips @ 0.25 g (16 x each) in the shades EB, EL, EM, ED
Catalog Number
220806
Brand Name
Ecosite Elements
Version/Model Number
220806
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EBF
Product Code Name
Material, Tooth Shade, Resin
Public Device Record Key
a0ffccf6-e0aa-40e6-a2b2-d495262067c9
Public Version Date
November 15, 2021
Public Version Number
2
DI Record Publish Date
September 06, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 143 |