Identity
- Trade Name
- KALORE™ FDA UDI
- Generic Name
- Light-cured dental restorative composite resin FDA UDI
- Device Name
- KALORE™ Trial Kit (20 unitips of each: A1, A2. 10 unitips of BW (.16mL each) FDA UDI
- Model / Reference
- 003569 FDA UDI
- Description
- KALORE™ Trial Kit (20 unitips of each: A1, A2. 10 unitips of BW (.16mL each) FDA UDI
Identifiers
- Catalog Number
- 003569 FDA UDI
- Primary DI / UDI-DI
- D0470035691 FDA UDI
- 510(k) Number
- K082434 FDA UDI
- FDA Product Code
- EBF FDA UDI
- GMDN Term
- Light-cured dental restorative 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
No
FDA UDI
Category: Light-cured dental restorative composite resin
Kalore™ by Gc America Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Light-cured dental restorative composite resin.
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Cleared under the same submission
K082434 also covers:
- KALORE™ — Gc America Inc.
- KALORE™ — Gc America Inc.
- KALORE™ — Gc America Inc.
- KALORE™ — Gc America Inc.
- KALORE™ — Gc America Inc.
- KALORE™ — Gc America Inc.
- KALORE™ — Gc America Inc.
- KALORE™ — Gc America Inc.
- KALORE™ — Gc America Inc.
- KALORE™ — Gc America Inc.
- KALORE™ — Gc America Inc.
- KALORE™ — Gc America 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Gc America Inc.
Sources (1)
- FDA UDI 123494a5-2ccf-4cbe-98af-6271ed782e87 37 fields · synced Jun 1, 2026