Identity
- Trade Name
- OdneCure FDA UDI
- Generic Name
- Dental/surgical polymerization lamp FDA UDI
- Device Name
- 1 OdneCure Root Canal Cleaning Device consisting of Charging stand, 2 batteries, body of the lamp, packaged with Cable, Plug, 500 Sleeves, IFU, quick guide FDA UDI
- Model / Reference
- E-0001 FDA UDI
- Description
- 1 OdneCure Root Canal Cleaning Device consisting of Charging stand, 2 batteries, body of the lamp, packaged with Cable, Plug, 500 Sleeves, IFU, quick guide FDA UDI
Identifiers
- Catalog Number
- E-0001 FDA UDI
- Primary DI / UDI-DI
- 07649988156694 FDA UDI
- 510(k) Number
- K232076 FDA UDI
- FDA Product Code
- QNF 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
No
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental/surgical polymerization lamp
OdneCure by Odne AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental/surgical polymerization lamp.
- LEDEX — Dentmate Technology Co. , Ltd. · Class II
- Flashlite® — Den-Mat Holdings, LLC · Class II
- WOODPECKER — Guilin Woodpecker Medical Instrument Co., Ltd. · Class II
- VALO — ULTRADENT PRODUCTS, INC. · Class II
- WOODPECKER — Guilin Woodpecker Medical Instrument Co., Ltd. · Class II
- VALO — ULTRADENT PRODUCTS, INC. · Class II
- Coltolux — Coltene/Whaledent Inc. · Class II
- Ascent PX Charging Station — CAO GROUP, INC. · Class II
Cleared under the same submission
K232076 also covers:
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
- Odne AG
Sources (1)
- FDA UDI d89902da-68cc-4148-81cb-354416d2f27e 35 fields · synced Jun 1, 2026