Identity
- Trade Name
- INTERVAL LC FDA UDI
- Generic Name
- Dental acrylic resin FDA UDI
- Device Name
- LIGHT CURE DENTAL FILLING MATERIAL FDA UDI
- Model / Reference
- 7575 FDA UDI
- Description
- LIGHT CURE DENTAL FILLING MATERIAL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850015110344 FDA UDI
- 510(k) Number
- K903551 FDA UDI
- FDA Product Code
- EBF FDA UDI
- GMDN Term
- Dental acrylic 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
No
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
No
FDA UDI
Category: Dental acrylic resin
Interval Lc by Temrex Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental acrylic resin.
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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.
- SciPharm Tempo-Rex Temporary/Intermediate Restoratives — 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
- Temrex Corp.
Sources (1)
- FDA UDI a17024d2-b28d-4df7-9297-91fa174fb848 34 fields · synced May 29, 2026