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SciPharm Tempo-Rex Temporary/Intermediate Restoratives
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- SciPharm Tempo-Rex Temporary/Intermediate Restoratives FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Tempo-Rex is a versatile light-cured material for making temporary/intermediate restorations, as a restorative for deciduous teeth, and for making temporary crowns, inlays, and onlays, endodontic stopping, and emergency restorations. Gray/Brown Shade. Non-Boxed. FDA UDI
- Model / Reference
- SP 50-603 N FDA UDI
- Description
- Tempo-Rex is a versatile light-cured material for making temporary/intermediate restorations, as a restorative for deciduous teeth, and for making temporary crowns, inlays, and onlays, endodontic stopping, and emergency restorations. Gray/Brown Shade. Non-Boxed. FDA UDI
Identifiers
- Catalog Number
- 50-603 FDA UDI
- Primary DI / UDI-DI
- D801SP50603N1 FDA UDI
- 510(k) Number
- K903551 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 Tempo-Rex Temporary/Intermediate Restoratives 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
K903551 also covers:
- Tempit — CENTRIX, INC.
- Tempit — CENTRIX, INC.
- MASTER-DENT — DENTONICS, INC.
- SciPharm Tempo-Rex Temporary/Intermediate Restoratives — SCIENTIFIC PHARMACEUTICALS, INC.
- SciPharm Tempo-Rex Temporary/Intermediate Restoratives — SCIENTIFIC PHARMACEUTICALS, INC.
- SciPharm Tempo-Rex Temporary/Intermediate Restoratives — SCIENTIFIC PHARMACEUTICALS, INC.
- SciPharm Tempo-Rex Temporary/Intermediate Restoratives — SCIENTIFIC PHARMACEUTICALS, INC.
- SciPharm Tempo-Rex Temporary/Intermediate Restoratives — SCIENTIFIC PHARMACEUTICALS, INC.
- SciPharm Tempo-Rex Temporary/Intermediate Restoratives — SCIENTIFIC PHARMACEUTICALS, INC.
- SciPharm Tempo-Rex Temporary/Intermediate Restoratives — SCIENTIFIC PHARMACEUTICALS, INC.
- INTERVAL LC — Temrex Corp.
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 cfad9201-fe8e-477c-8c6b-110a11c13439 37 fields · synced Jun 8, 2026