Identity
- Trade Name
- Slimax-C Plus FDA UDI
- Generic Name
- Dental laboratory curing unit FDA UDI
- Device Name
- LED Curing Light, Blue, Built-in Radiometer FDA UDI
- Model / Reference
- SM1003P-B FDA UDI
- Description
- LED Curing Light, Blue, Built-in Radiometer FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00628504370674 FDA UDI
- 510(k) Number
- K080025 FDA UDI
- FDA Product Code
- EBZ FDA UDI
- GMDN Term
- Dental laboratory curing unit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.6070 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental laboratory curing unit
Slimax-C Plus by Beyes Dental Canada Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K080025 also covers:
- Luminary-3D Dental — 3D DENTAL DESIGNS AND DEVELOPMENT, LLC
- Slimax-C Plus — Beyes Dental Canada Inc
- Slimax-C Plus — Beyes Dental Canada Inc
- Slimax-C Plus — Beyes Dental Canada Inc
- Slimax-C Plus — Beyes Dental Canada Inc
- Slimax-C Plus — Beyes Dental Canada Inc
- FLIGHT DENTAL SYSTEMS — Flight Dental Systems
- Flight Dental Systems — Flight Dental Systems
- DBA — Guilin Woodpecker Medical Instrument Co., Ltd.
- DTE — Guilin Woodpecker Medical Instrument Co., Ltd.
- DTE — Guilin Woodpecker Medical Instrument Co., Ltd.
- DTE — Guilin Woodpecker Medical Instrument Co., Ltd.
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
- Beyes Dental Canada Inc
Sources (1)
- FDA UDI c73aafc8-6662-46e6-a569-2caa1d78dca1 34 fields · synced Jun 8, 2026