FDA UDI
In Commercial Distribution
🇺🇸 United States
OdneCure
DI: 07649988156694
·
Model: E-0001
·
Odne AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- OdneCure
- Primary DI
- 07649988156694
- Version / Model
- E-0001
- Catalog Number
- E-0001
- Company Name
- Odne AG
- Labeler DUNS
- 480237899
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-02-01
- Public Version
- 1
- Public Version Date
- 2024-02-09
- Public Version Status
- New
- Public Device Record Key
- d89902da-68cc-4148-81cb-354416d2f27e
Device 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
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QNF | Laser Activator For Polymerization | Dental | 872.6070 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35775 | Dental/surgical polymerization lamp | A mains electricity (AC-powered), hand-held, device intended to be used to activate the polymerization of: 1) a dental resin-based material in the oral cavity; and/or 2) a surgical adhesive/sealant during an open-surgery procedure. It typically includes a light source [e.g., halogen, fluorescent, light-emitting diode (LED)] that emits light in the visible, or less frequently, ultraviolet spectrum, mounted in a handpiece that is typically attached to or used with a portable control unit or charging station. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07649988156694 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K232076 | 000 |