Identity
- Trade Name
- SciPharm Anterior/Posterior Restoratives FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- CuRay II - Visible Light-Cured, Highly Filled Composite Restorative For Use Primarily in Class I and Class II Restorations. Shade A2/A3.5. FDA UDI
- Model / Reference
- SP 51-11 FDA UDI
- Description
- CuRay II - Visible Light-Cured, Highly Filled Composite Restorative For Use Primarily in Class I and Class II Restorations. Shade A2/A3.5. FDA UDI
Identifiers
- Catalog Number
- 51-11 FDA UDI
- Primary DI / UDI-DI
- D801SP51111 FDA UDI
- 510(k) Number
- K823510 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
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 Restoratives by Scientific Pharmaceuticals, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K823510 also covers:
- VersaLite — CENTRIX, INC.
- VersaLite — CENTRIX, INC.
- VersaLite — CENTRIX, INC.
- VersaLite — CENTRIX, INC.
- VersaLite — CENTRIX, INC.
- VersaLite — CENTRIX, INC.
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC
- MASTER-DENT — DENTONICS, INC.
- MASTER-DENT — DENTONICS, INC.
- MASTER-DENT — DENTONICS, INC.
- MASTER-DENT — DENTONICS, INC.
- Henry Schein — HENRY SCHEIN, 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 8524d295-a6a1-4fb7-8592-cd1e9aa6cdf4 37 fields · synced May 30, 2026