DeltaFil

Basic Information

• Brand Name: DeltaFil
• Primary DI: EDMG5400041
• Version / Model: 540004
• Catalog Number: 540004
• Company Name: DMG Chemisch-Pharmazeutische Fabrik GmbH
• Labeler DUNS: 320744915
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2022-06-13
• Public Version: 3
• Public Version Date: 2022-10-26
• Public Version Status: Update
• Public Device Record Key: 7dab1cf6-694a-4490-9e8d-813492765d02

Device Description

DeltaFil is a radiopaque, classic glass ionomer restorative material in capsule form. DeltaFil chemically bonds to enamel and dentine and releases fluoride ions. It is available in the shades A1, A2, A3 and A4 based on the Vita color system and White and Dark. Each capsule contains a minimum usable amount of 0.13 ml. DeltaFil Conditioner is an aqueous polyacrylic acid solution for treating the smear layer following preparation and for conditioning the cavity, which optimizes the bonding of DeltaFil to the tooth’s structure. DeltaFil 50 Applicap @ 370 mg powder, 75 mg liquid (0.07 ml), Shade A4

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EMA	Cement, Dental	Dental	872.3275	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16704	Glass ionomer dental cement	A non-sterile substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between an aluminosilicate glass powder and an aqueous solution of a polyalkenoic acid. It typically includes some additional fillers, and may include setting substances that are in the minority (e.g., resin, metal). After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	EDMG5400040	HIBCC
Primary	EDMG5400041	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Dry
• Type: Storage Environment Temperature
• Temperature Range: 15 – 25 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 59 – 77 Degrees Fahrenheit