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SciPharm Anterior/Posterior Composite Resin Paste/Paste
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- SciPharm Anterior/Posterior Composite Resin Paste/Paste FDA UDI
- Generic Name
- Self-cured dental restorative composite resin FDA UDI
- Device Name
- Anterior/Posterior Resin Based Restorative Material FDA UDI
- Model / Reference
- SP 50-04 FDA UDI
- Description
- Anterior/Posterior Resin Based Restorative Material FDA UDI
Identifiers
- Catalog Number
- 50-04 FDA UDI
- Primary DI / UDI-DI
- D80150041 FDA UDI
- 510(k) Number
- K791078 FDA UDI
- FDA Product Code
- EBD FDA UDI
- GMDN Term
- Self-cured dental restorative composite resin FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3310 FDA UDI
- Commercial Distribution
- 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Self-cured dental restorative composite resin
SciPharm Anterior/Posterior Composite Resin Paste/Paste by Scientific Pharmaceuticals, Inc. — Class II — FDA UDI — listed in FDA GUDID
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Also classified as Self-cured dental restorative composite resin.
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Cleared under the same submission
K791078 also covers:
- MASTER-DENT — DENTONICS, INC.
- MASTER-DENT — DENTONICS, INC.
- MASTER-DENT — DENTONICS, INC.
- MASTER-DENT — DENTONICS, INC.
- MASTER-DENT — DENTONICS, INC.
- SciPharm Anterior/Posterior Composite Bonding Agent, Part A — SCIENTIFIC PHARMACEUTICALS, INC.
- SciPharm Anterior/Posterior Composite Bonding Agent, Part B — SCIENTIFIC PHARMACEUTICALS, INC.
- SciPharm Anterior/Posterior Resin Based Paste Jar, Part B — SCIENTIFIC PHARMACEUTICALS, INC.
- SciPharm Anterior/Posterior Resin Based Paste, Part A — SCIENTIFIC PHARMACEUTICALS, INC.
- SciPharm Anterior/Posterior Resin Based Paste/Paste Spanish — SCIENTIFIC PHARMACEUTICALS, INC.
- SciPharm Anterior/Posterior Restoratives — SCIENTIFIC PHARMACEUTICALS, INC.
- SciPharm Non-Activated Porcelain Conditioner, Non-Boxed — SCIENTIFIC PHARMACEUTICALS, INC.
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
- Scientific Pharmaceuticals, Inc.
Sources (1)
- FDA UDI aab876ff-9e41-4527-9209-5036d69fafa4 36 fields · synced Jun 1, 2026