Identity
- Trade Name
- Epic® FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- B3 Epic®-TmpT Composite in .25-gram Unit-Dose Capsules (Pkg. of 15 Capsules) FDA UDI
- Model / Reference
- S365UD FDA UDI
- Description
- B3 Epic®-TmpT Composite in .25-gram Unit-Dose Capsules (Pkg. of 15 Capsules) FDA UDI
Identifiers
- Catalog Number
- S365UD FDA UDI
- Primary DI / UDI-DI
- M595S365UD1 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
- 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Epic® by Parkell, Inc. — 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
- Parkell, Inc.
Sources (1)
- FDA UDI 65e9c0d1-675b-4602-9d4e-6b43ba3a13ae 37 fields · synced May 31, 2026