DeltaFil 540010
GUDID EDMG5400100
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 Sample Pack: 5 Applicap @ 370 mg powder, 75 mg liquid (0.07 ml) (3x Shade A2, 1x White, 1x Dark), DeltaFil Conditioner 1 Bottle @ 2 g
DMG Chemisch-Pharmazeutische Fabrik GmbH
Glass ionomer dental cement| Primary Device ID | EDMG5400100 |
| NIH Device Record Key | 49fdf5a4-58e3-411e-bd3c-b9025cb1eae6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DeltaFil |
| Version Model Number | 540010 |
| Catalog Number | 540010 |
| Company DUNS | 320744915 |
| Company Name | DMG Chemisch-Pharmazeutische Fabrik GmbH |
| Device Count | 50 |
| 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 | true |
| 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 |
| ccosta@dmg-america.com | |
| Phone | 201-894-5505 |
| ccosta@dmg-america.com | |
| Phone | 201-894-5505 |
| ccosta@dmg-america.com | |
| Phone | 201-894-5505 |
| ccosta@dmg-america.com | |
| Phone | 201-894-5505 |
| ccosta@dmg-america.com | |
| Phone | 201-894-5505 |
| ccosta@dmg-america.com | |
| Phone | 201-894-5505 |
| ccosta@dmg-america.com | |
| Phone | 201-894-5505 |
| ccosta@dmg-america.com | |
| Phone | 201-894-5505 |
| ccosta@dmg-america.com | |
| Phone | 201-894-5505 |
| ccosta@dmg-america.com | |
| Phone | 201-894-5505 |
| ccosta@dmg-america.com | |
| Phone | 201-894-5505 |
| ccosta@dmg-america.com | |
| Phone | 201-894-5505 |
| ccosta@dmg-america.com | |
| Phone | 201-894-5505 |
| ccosta@dmg-america.com | |
| Phone | 201-894-5505 |
| ccosta@dmg-america.com | |
| Phone | 201-894-5505 |
| ccosta@dmg-america.com | |
| Phone | 201-894-5505 |
| ccosta@dmg-america.com | |
| Phone | 201-894-5505 |
| ccosta@dmg-america.com |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Dry |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | EDMG5400100 [Unit of Use] |
| HIBCC | EDMG5400101 [Primary] |
FDA Product Code
| EMA | Cement, Dental |
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 | 2022-11-07 |
| Device Publish Date | 2022-10-28 |
On-Brand Devices [DeltaFil]
| EDMG5400040 | DeltaFil is a radiopaque, classic glass ionomer restorative material in capsule form. DeltaFil c |
| EDMG5400030 | DeltaFil is a radiopaque, classic glass ionomer restorative material in capsule form. DeltaFil c |
| EDMG5400020 | DeltaFil is a radiopaque, classic glass ionomer restorative material in capsule form. DeltaFil c |
| EDMG5400010 | DeltaFil is a radiopaque, classic glass ionomer restorative material in capsule form. DeltaFil c |
| EDMG5400000 | DeltaFil is a radiopaque, classic glass ionomer restorative material in capsule form. DeltaFil c |
| EDMG5400100 | DeltaFil is a radiopaque, classic glass ionomer restorative material in capsule form. DeltaFil c |
| EDMG5400060 | DeltaFil is a radiopaque, classic glass ionomer restorative material in capsule form. DeltaFil c |
| EDMG5400050 | DeltaFil is a radiopaque, classic glass ionomer restorative material in capsule form. DeltaFil c |
Trademark Results [DeltaFil]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DELTAFIL 79307782 not registered Live/Pending |
Mühlbauer Technology GmbH 2021-02-24 |
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