Honigum MixStar Heavy 999537

GUDID EDMG9995378

Impression material, heavy-bodied consistency. Professional precision. Content: 1 cartridge @ 380 ml paste, Accessories

DMG Chemisch-Pharmazeutische Fabrik GmbH

Silicone dental impression material

• Primary Device ID: EDMG9995378
• NIH Device Record Key: 2bbd771a-373d-4efa-9ea2-7c4cf8fbe820
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Honigum MixStar Heavy
• Version Model Number: 999537
• Catalog Number: 999537
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EDMG9995370 [Primary]
HIBCC	EDMG9995371 [Package]; Contains: EDMG9995370; Package: [1 Units]; In Commercial Distribution
HIBCC	EDMG9995378 [Package]; Contains: EDMG9995371; Package: [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K000878

FDA Product Code

• ELW: Material, Impression

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-22

Devices Manufactured by DMG Chemisch-Pharmazeutische Fabrik GmbH

• 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
• EDMG1102661 - Automix-Tips Blue 1:1: 2022-09-09 Automix-Tips Blue 1:1. Suitable for: PermaCem Automix, PermaCem Automix Dual, TempoCem Automix, TempoCem NE Automix. Content: 50