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 ID: EDMG2207501
• NIH Device Record Key: 2b9bca9f-259d-499a-b7c4-7a546d768570
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ecosite Bulk Fill
• Version Model Number: 220750
• Catalog Number: 220750
• Company DUNS: 320744915
• Company Name: DMG Chemisch-Pharmazeutische Fabrik GmbH
• Device Count: 3
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EDMG2207500 [Unit of Use]
HIBCC	EDMG2207501 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171772

FDA Product Code

• EBF: Material, Tooth Shade, Resin

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-07-08
• Device Publish Date: 2019-06-30

On-Brand Devices [Ecosite Bulk Fill]

• EDMG2207571: Light-curing, radiopaque Bulk Fill. Quality fillings in no time. Content: 16 Safetips @ 0.25 g,
• EDMG2207561: Light-curing, radiopaque Bulk Fill. Quality fillings in no time. Content: 16 Safetips @ 0.25 g,
• EDMG2207551: Light-curing, radiopaque Bulk Fill. Quality fillings in no time. Content: 16 Safetips @ 0.25 g,
• EDMG2207541: Light-curing, radiopaque Bulk Fill. Quality fillings in no time. Content: 1 Syringe @ 4 g, shade
• EDMG2207531: Light-curing, radiopaque Bulk Fill. Quality fillings in no time. Content: 1 Syringe @ 4 g, shade
• EDMG2207521: Light-curing, radiopaque Bulk Fill. Quality fillings in no time. Content: 1 Syringe @ 4 g, shade
• EDMG2207511: Light-curing, radiopaque Bulk Fill. Quality fillings in no time. Content: 48 Safetips @ 0.25 g i
• EDMG2207501: Light-curing, radiopaque Bulk Fill. Quality fillings in no time. Content: 3 Syringes @ 4 g in th