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SciPharm Anterior/Posterior Resin Based Paste, Part A
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- SciPharm Anterior/Posterior Resin Based Paste, Part A FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Highly Filled Composite Restorative For Use Primarily in Class I and Class II Restoratives. FDA UDI
- Model / Reference
- SP 50-041 FDA UDI
- Description
- Highly Filled Composite Restorative For Use Primarily in Class I and Class II Restoratives. FDA UDI
Identifiers
- Catalog Number
- 50-041 FDA UDI
- Primary DI / UDI-DI
- D801SP500411 FDA UDI
- 510(k) Number
- K791078 FDA UDI
- FDA Product Code
- EBD FDA UDI
- GMDN Term
- Dental 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental composite resin
SciPharm Anterior/Posterior Resin Based Paste, Part A by Scientific Pharmaceuticals, Inc. — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Dental composite resin.
- Name: Light Curing Composite Model: Flow — Micerium S.p.A. · Class IIa
- Forma S — ULTRADENT PRODUCTS, INC. · Class II
- NovaPro Fill — NANOVA BIOMATERIALS INC · Class II
- SimpliShade — KERR CORPORATION · Class II
- 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
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 Composite Resin Paste/Paste — SCIENTIFIC PHARMACEUTICALS, INC.
- SciPharm Anterior/Posterior Resin Based Paste Jar, Part B — 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 8b345fe0-0678-4eda-9411-2d705e5854fc 37 fields · synced May 30, 2026