PermaCem Smartmix Dual 212035

GUDID EDMG2120351

Permanent luting cement automix system. The highlight of restorations. Content: 2 syringes @ 10 g paste, Accessories

DMG Chemisch-Pharmazeutische Fabrik GmbH

Dental composite resin

• Primary Device ID: EDMG2120351
• NIH Device Record Key: 5e6a38c4-8dce-4b84-83d2-31f615350fa4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PermaCem Smartmix Dual
• Version Model Number: 212035
• Catalog Number: 212035
• 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 36 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EDMG2120350 [Primary]
HIBCC	EDMG2120351 [Package]; Contains: EDMG2120350; Package: [2 Units]; In Commercial Distribution
HIBCC	EDMG2120358 [Package]; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K982895

FDA Product Code

• EMA: Cement, Dental

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

• 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
• EDMG1103511 - Automix-Tips Blue 10:1: 2022-09-09 Automix-Tips Blue 10:1. Suitable for: Luxatemp Ultra, Luxatemp Fluorescence, Luxatemp Plus, Luxatemp Solar.