Identity
- Trade Name
- DeltaFil FDA UDI
- Generic Name
- Glass ionomer dental cement FDA UDI
- Device Name
- 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, A3.5 and A4 based on the Vita color system. 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 A3.5 FDA UDI
- Model / Reference
- 540003 FDA UDI
- 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, A3.5 and A4 based on the Vita color system. 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 A3.5 FDA UDI
Identifiers
- Catalog Number
- 540003 FDA UDI
- Primary DI / UDI-DI
- EDMG5400031 FDA UDI
- FDA Product Code
- EMA FDA UDI
- GMDN Term
- Glass ionomer dental cement FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3275 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
DeltaFil by DMG Chemisch-Pharmazeutische Fabrik GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- DMG Chemisch-Pharmazeutische Fabrik GmbH
Sources (1)
- FDA UDI b1e1389a-7c8d-475b-a946-75c83c0755e2 37 fields · synced May 30, 2026