Identity
- Trade Name
- D-LUX+ FDA UDI
- Generic Name
- Dental/surgical polymerization lamp FDA UDI
- Device Name
- D-Lux+ is a dental curing light which is used for polymerization resinous dental materials. FDA UDI
- Model / Reference
- DISPOSABLE SHEATH FDA UDI
- Description
- D-Lux+ is a dental curing light which is used for polymerization resinous dental materials. FDA UDI
Identifiers
- Catalog Number
- 4008-1170 FDA UDI
- Primary DI / UDI-DI
- 08806383568845 FDA UDI
- 510(k) Number
- K200809 FDA UDI
- FDA Product Code
- EBZ FDA UDI
- GMDN Term
- Dental/surgical polymerization lamp 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
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental/surgical polymerization lamp
D-Lux+ by DiaDent Group International — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K200809 also covers:
- D-LUX+ — DiaDent Group International
- D-LUX+ — DiaDent Group International
- D-LUX+ — DiaDent Group International
- D-LUX+ — DiaDent Group International
- D-LUX+ — DiaDent Group International
- D-LUX+ — DiaDent Group International
- D-LUX+ — DiaDent Group International
- D-LUX+ — DiaDent Group International
- D-LUX+ — DiaDent Group International
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
- DiaDent Group International
Sources (1)
- FDA UDI 767527ed-36a0-4175-a9e2-57cf89d1b7ce 36 fields · synced May 30, 2026