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…
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
Who Else Makes It
Concentrated in Shandong (2), Guangdong (1).
Record
Regulatory record for DeltaFil | Listed by | DMG Chemisch Pharmazeutische Fabrik Gmbh, Germany |
| FDA product code | EMA |
| Device type | Cement, Dental |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3275 |
| Establishment | Manufacturer |
| Record published | 2022-06-13 |
| Record revised | 2022-10-28 (version 5) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, serial number |
| Storage | Special storage condition: Dry; Storage environment temperature 15 to 25 °C; Storage environment temperature 59 to 77 °F |
| Distribution end date | 2022-10-28 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.