Ecosite Bulk Fill 220750

GUDID EDMG2207501

Light-curing, radiopaque Bulk Fill. Quality fillings in no time. Content: 3 Syringes @ 4 g in the shades Universal (2 x), Light (1 x), 1 bottle @ 5 ml of Ecosite Bond.

DMG Chemisch-Pharmazeutische Fabrik GmbH

Dental composite resin
Primary Device IDEDMG2207501
NIH Device Record Key2b9bca9f-259d-499a-b7c4-7a546d768570
Commercial Distribution StatusIn Commercial Distribution
Brand NameEcosite Bulk Fill
Version Model Number220750
Catalog Number220750
Company DUNS320744915
Company NameDMG Chemisch-Pharmazeutische Fabrik GmbH
Device Count3
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone201-894-5505
Emaileanagnostos@dmg-america.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEDMG2207500 [Unit of Use]
HIBCCEDMG2207501 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBFMaterial, Tooth Shade, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-07-08
Device Publish Date2019-06-30

On-Brand Devices [Ecosite Bulk Fill]

EDMG2207571Light-curing, radiopaque Bulk Fill. Quality fillings in no time. Content: 16 Safetips @ 0.25 g,
EDMG2207561Light-curing, radiopaque Bulk Fill. Quality fillings in no time. Content: 16 Safetips @ 0.25 g,
EDMG2207551Light-curing, radiopaque Bulk Fill. Quality fillings in no time. Content: 16 Safetips @ 0.25 g,
EDMG2207541Light-curing, radiopaque Bulk Fill. Quality fillings in no time. Content: 1 Syringe @ 4 g, shade
EDMG2207531Light-curing, radiopaque Bulk Fill. Quality fillings in no time. Content: 1 Syringe @ 4 g, shade
EDMG2207521Light-curing, radiopaque Bulk Fill. Quality fillings in no time. Content: 1 Syringe @ 4 g, shade
EDMG2207511Light-curing, radiopaque Bulk Fill. Quality fillings in no time. Content: 48 Safetips @ 0.25 g i
EDMG2207501Light-curing, radiopaque Bulk Fill. Quality fillings in no time. Content: 3 Syringes @ 4 g in th

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