Coltolux LED Light Curing System, 230/240V
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Identity
- Trade Name
- Coltolux LED Light Curing System, 230/240V EUDAMEDColtolux FDA UDI
- Generic Name
- Dental/surgical polymerization lamp FDA UDI
- Device Name
- LED Curing Lights EUDAMEDColtolux LED Light Curing System, 230/240V FDA UDI
- Model / Reference
- C7970230240 EUDAMEDFDA UDI
- Description
- Coltolux LED Light Curing System, 230/240V FDA UDI
Identifiers
- Primary DI / UDI-DI
- D661C79702302400 EUDAMEDFDA UDI
- Basic UDI-DI
- ++D661076L2 EUDAMED
- 510(k) Number
- K040551 FDA UDI
- FDA Product Code
- EBZ FDA UDI
- EMDN Code
- Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
- GMDN Term
- Dental/surgical polymerization lamp FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 872.6070 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
Category: Dental appliance fabrication material, ceramic
Coltolux LED Light Curing System, 230/240V by Coltene/Whaledent Inc. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
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Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K945698 | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K040551 | Class I | Active |
| EUDAMED | European Union | CE/MDR | ++D661076L2 | Class I | Active |
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Manufacturer
- Manufacturer
- Coltene/Whaledent Inc.
- EUDAMED SRN
- US-MF-000015761
- Authorised Representative
- Coltène/Whaledent GmbH + Co. KG DE-AR-000005719
Sources (3)
- EUDAMED d3b51b14-4d89-489c-9208-4a5fd34d3c05 61 fields · synced Jul 15, 2026
- FDA UDI 21e595ba-a140-495a-b736-822876379b75 36 fields · synced May 30, 2026
- FDA 510(k) K945698 1 fields · synced May 18, 2026