AccessGUDID - DEVICE: Ecosite Elements (EDMG2208051)

GUDID

Device Identifier (DI) Information

Brand Name: Ecosite Elements
Version or Model: 220805
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 220805
Company Name: DMG Chemisch-Pharmazeutische Fabrik GmbH

Primary DI Number: EDMG2208051
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 80
Labeler D-U-N-S® Number*: 320744915 *Terms of Use

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: 80 Safetips @ 0.25 g (16 x each) in the shades B1, A2, A3, A3.5, A4, 1 bottle @ 5 ml Ecosite-Bond

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35870	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBF	Material, Tooth Shade, Resin

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 36 and 77 Degrees Fahrenheit
Storage Environment Temperature: between 2 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9f2adc2e-0699-415a-9073-8bc65f875a2d
Public Version Date: November 15, 2021
Public Version Number: 2
DI Record Publish Date: September 06, 2019