Ecosite Bond 220758

GUDID EDMG2207581

Light-curing single component bonding agent. Quality fillings in no time. Content: 1 Bottle @ 5 ml of Ecosite Bond.

DMG Chemisch-Pharmazeutische Fabrik GmbH

Dentine bonding agent/set

• Primary Device ID: EDMG2207581
• NIH Device Record Key: d321a6e7-00b4-4ea6-adab-a9976460a13c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ecosite Bond
• Version Model Number: 220758
• Catalog Number: 220758
• Company DUNS: 320744915
• Company Name: DMG Chemisch-Pharmazeutische Fabrik GmbH
• Device Count: 1
• 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
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EDMG2207580 [Primary]
HIBCC	EDMG2207581 [Package]; Contains: EDMG2207580; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080480

FDA Product Code

• KLE: Agent, Tooth Bonding, Resin

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-06-25
• Device Publish Date: 2017-11-01

Devices Manufactured by DMG Chemisch-Pharmazeutische Fabrik GmbH

• EDMG2240081 - LuxaFlow® Ultra BL: 2024-12-09 Flowable light cure provisional add-on material Refill Content: 2 Syringes @ 1.5 g, 10 Luer-Lock-Tips. Color: BL
• EDMG2228291 - Safetip Dispenser Pro: 2024-07-22 Dispenser for direct application with all commercially available composite tips. e. g. suitable for Ecosite Elements.
• EDMG2229010 - Ecosite One: 2023-11-30 Ecosite One is a light-curing, radiopaque composite for direct fillings, especially suitable for use in the posterior region.
• EDMG2229020 - Ecosite One: 2023-11-30 Ecosite One is a light-curing, radiopaque composite for direct fillings, especially suitable for use in the posterior region.
• EDMG2229001 - Ecosite One: 2023-11-29 Ecosite One is a light-curing, radiopaque composite for direct fillings, especially suitable for use in the posterior region.
• EDMG5400050 - DeltaFil: 2022-11-07 DeltaFil is a radiopaque, classic glass ionomer restorative material in capsule form. DeltaFil chemically bonds to enamel and de
• EDMG5400060 - DeltaFil: 2022-11-07 DeltaFil is a radiopaque, classic glass ionomer restorative material in capsule form. DeltaFil chemically bonds to enamel and de
• EDMG5400100 - DeltaFil: 2022-11-07 DeltaFil is a radiopaque, classic glass ionomer restorative material in capsule form. DeltaFil chemically bonds to enamel and de