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SciPharm Support Self Cured Core Build-Up Restorative
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- SciPharm Support Self Cured Core Build-Up Restorative FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Self-Cured, Core Build-Up Composite Restorative Material. All Contrast Kit. FDA UDI
- Model / Reference
- SP 55-19 FDA UDI
- Description
- Self-Cured, Core Build-Up Composite Restorative Material. All Contrast Kit. FDA UDI
Identifiers
- Catalog Number
- 55-19 FDA UDI
- Primary DI / UDI-DI
- D801SP55191 FDA UDI
- 510(k) Number
- K823732 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 Support Self Cured Core Build-Up Restorative by Scientific Pharmaceuticals, Inc. — Class II — FDA UDI — listed in FDA GUDID
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Also classified as Dental composite resin.
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- Llis — Dentscare Ltda · Class II
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- OMNICHROMA — TOKUYAMA DENTAL CORPORATION · Class II
Cleared under the same submission
K823732 also covers:
- SciPharm Pit & Fissure Sealer Bonding Agent — SCIENTIFIC PHARMACEUTICALS, INC.
- SciPharm Support Core Build-Up — SCIENTIFIC PHARMACEUTICALS, INC.
- SciPharm Support Core Build-Up — SCIENTIFIC PHARMACEUTICALS, INC.
- SciPharm Support Core Build-Up — SCIENTIFIC PHARMACEUTICALS, INC.
- SciPharm Support Self Cured Core Build-Up Restorative — SCIENTIFIC PHARMACEUTICALS, INC.
- SciPharm Support Self Cured Core Build-Up Restorative — SCIENTIFIC PHARMACEUTICALS, INC.
- SciPharm Support Self Cured Core Build-Up Restorative — SCIENTIFIC PHARMACEUTICALS, INC.
- SciPharm Support Self Cured Core Build-Up Restorative — SCIENTIFIC PHARMACEUTICALS, INC.
- SciPharm Support Self Cured Core Build-Up Restorative — SCIENTIFIC PHARMACEUTICALS, INC.
- SciPharm Support Self Cured Core Build-Up Restorative — SCIENTIFIC PHARMACEUTICALS, INC.
- SciPharm Support Self Cured Core Build-Up Restorative Part A Catalyst Jar NonBox — SCIENTIFIC PHARMACEUTICALS, INC.
- SciPharm Support Self Cured Core Build-Up Restorative Part A Contrast 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 445daf24-1dbe-408f-b58e-16ef1b4fca16 37 fields · synced Jun 1, 2026