Coltolux Comfort Kit, International
EUDAMEDFDA UDIClass I (EU MDR)
by Dent4You AG
Identity
- Trade Name
- Coltolux Comfort Kit, International EUDAMEDColtolux Comfort FDA UDI
- Generic Name
- LED dental light, battery-powered FDA UDI
- Device Name
- Coltolux Comfort LED Curing Light EUDAMEDCOLTOLUX COMFORT KIT, INTERNATIONAL FDA UDI
- Model / Reference
- 60034390 EUDAMEDFDA UDI
- Description
- COLTOLUX COMFORT KIT, INTERNATIONAL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630392901406 EUDAMEDFDA UDI
- Basic UDI-DI
- 76303929COMFORTLEDEP EUDAMED
- 510(k) Number
- K223142 FDA UDI
- FDA Product Code
- EBZ FDA UDI
- EMDN Code
- Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
- GMDN Term
- LED dental light, battery-powered 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
Yes
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
Yes
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
Yes
Category: Dental appliance fabrication material, ceramic
Coltolux Comfort Kit, International by Dent4You AG — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 76303929COMFORTLEDEP | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Dent4You AG
- EUDAMED SRN
- CH-MF-000028926
- Authorised Representative
- Coltène/Whaledent GmbH + Co. KG DE-AR-000005719
Sources (2)
- EUDAMED 7d14bd62-8576-4f1e-9db5-4895ac5a4bde 61 fields · synced Jul 31, 2026
- FDA UDI 2ca1baa4-6c4a-4054-969b-c978a3d990a0 35 fields · synced May 30, 2026