Identity
- Trade Name
- Ezfil A4 FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Dental composite resin is a device intended to restore carious lesions or structural defects in teeth. Ezfil is indicated for Class 1, 2, 3, 4, 5 restorations, Core-buildup to replace missing tooth structure, Diastema closures, Direct veneers, Composite and porcelain repairs. The color is 18 colors with A1, A2, A3, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, D4, OP and TL. FDA UDI
- Model / Reference
- 9420 FDA UDI
- Description
- Dental composite resin is a device intended to restore carious lesions or structural defects in teeth. Ezfil is indicated for Class 1, 2, 3, 4, 5 restorations, Core-buildup to replace missing tooth structure, Diastema closures, Direct veneers, Composite and porcelain repairs. The color is 18 colors with A1, A2, A3, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, D4, OP and TL. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806387894209 FDA UDI
- FDA Product Code
- EBF FDA UDI
- GMDN Term
- Dental composite resin FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3690 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental composite resin
Ezfil A4 by Meta Biomed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Bright Flow Core DC 5ml Dentine — DMP Dental Industry S.A. · Class IIa
- Llis — Dentscare Ltda · Class II
- Capo Universal, 6 g — Schütz Dental GmbH · Class II
- OMNICHROMA — TOKUYAMA DENTAL CORPORATION · Class II
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
- Meta Biomed, Inc.
Sources (1)
- FDA UDI 7aba236d-ba80-4aa9-b771-8358e115c588 33 fields · synced Jun 1, 2026