FDA.reportPublic FDA data

Ecosite Elements Pure Refill A3.5

Primary DI
EDMG2228231
Brand
Ecosite Elements Pure Refill A3.5
Company
DMG Chemisch-Pharmazeutische Fabrik GmbH
Model
222283
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 (Opaque 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 opaque covering layer. The shade B is an ideal choice for fissures and the replication of brown spots."
Published
2026-10-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
EBFMaterial, Tooth Shade, Resin

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EDMG2228231PrimaryHIBCC0

Regulatory Flags#

DUNS number
320744915
Device count
1
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 table
Primary DIBrandModelCatalogPublished
EDMG2228071Ecosite Elements Pure Refill B12228072026-10-30
EDMG2228081Ecosite Elements Pure Refill A22228082026-10-30
EDMG2228091Ecosite Elements Pure Refill A32228092026-10-30
EDMG2228101Ecosite Elements Pure Refill A3.52228102026-10-30
EDMG2228121Ecosite Elements Layer Refill EB2228122026-10-30
EDMG2228131Ecosite Elements Layer Refill EL2228132026-10-30
EDMG2228141Ecosite Elements Layer Refill EM2228142026-10-30
EDMG2228151Ecosite Elements Layer Refill ED2228152026-10-30
EDMG2228161Ecosite Elements Highlight Refill Incisal2228162026-10-30
EDMG2228171Ecosite Elements Highlight Refill OA22228172026-10-30
EDMG2228181Ecosite Elements Highlight Refill White2228182026-10-30
EDMG2228191Ecosite Elements Highlight Refill Brown2228192026-10-30
EDMG2228201Ecosite Elements Pure Refill B12228202026-10-30
EDMG2228211Ecosite Elements Pure Refill A22228212026-10-30
EDMG2228221Ecosite Elements Pure Refill A32228222026-10-30
EDMG2228251Ecosite Elements Layer Refill EB2228152026-10-30
EDMG2228261Ecosite Elements Layer Refill EL2228262026-10-30
EDMG2228271Ecosite Elements Layer Refill EM2228272026-10-30
EDMG2228281Ecosite Elements Layer Refill ED2228282026-10-30
EDMG2228401Ecosite Elements Pure Refill BL12228402026-10-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00766054003045BelixaESSENTIAL DENTAL SYSTEMS, INC.EBF2026-11-01
00766054003052BelixaESSENTIAL DENTAL SYSTEMS, INC.EBF2026-11-01
00766054003069BelixaESSENTIAL DENTAL SYSTEMS, INC.EBF2026-11-01
00766054003076BelixaESSENTIAL DENTAL SYSTEMS, INC.EBF2026-11-01
00766054003083BelixaESSENTIAL DENTAL SYSTEMS, INC.EBF2026-11-01
00766054003090BelixaESSENTIAL DENTAL SYSTEMS, INC.EBF2026-11-01
00766054003106BelixaESSENTIAL DENTAL SYSTEMS, INC.EBF2026-11-01
00766054003113BelixaESSENTIAL DENTAL SYSTEMS, INC.EBF2026-11-01
00766054003120BelixaESSENTIAL DENTAL SYSTEMS, INC.EBF2026-11-01
00766054003137BelixaESSENTIAL DENTAL SYSTEMS, INC.EBF2026-11-01
EDMG2228071Ecosite Elements Pure Refill B1DMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228081Ecosite Elements Pure Refill A2DMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228091Ecosite Elements Pure Refill A3DMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228101Ecosite Elements Pure Refill A3.5DMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228121Ecosite Elements Layer Refill EBDMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228131Ecosite Elements Layer Refill ELDMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228141Ecosite Elements Layer Refill EMDMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228151Ecosite Elements Layer Refill EDDMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228161Ecosite Elements Highlight Refill IncisalDMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228171Ecosite Elements Highlight Refill OA2DMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228181Ecosite Elements Highlight Refill WhiteDMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228191Ecosite Elements Highlight Refill BrownDMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228201Ecosite Elements Pure Refill B1DMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228211Ecosite Elements Pure Refill A2DMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228221Ecosite Elements Pure Refill A3DMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228251Ecosite Elements Layer Refill EBDMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228261Ecosite Elements Layer Refill ELDMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228271Ecosite Elements Layer Refill EMDMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228281Ecosite Elements Layer Refill EDDMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228401Ecosite Elements Pure Refill BL1DMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30