FDA UDI
In Commercial Distribution
🇺🇸 United States
IDUP board
DI: J00716011960051
·
Model: 1601196-005
·
Bien-Air Dental SA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- IDUP board
- Primary DI
- J00716011960051
- Version / Model
- 1601196-005
- Company Name
- Bien-Air Dental SA
- Labeler DUNS
- 480082080
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-09-11
- Public Version
- 1
- Public Version Date
- 2023-09-19
- Public Version Status
- New
- Public Device Record Key
- 4500532e-2236-4a2d-9c03-109e089d7c9a
Device Description
integrable devices are electronic boards that allow the control of Bien-Air Electric micromotors as well as various dental instruments. They are intended to be integrated into a dental unit (kart or dental chair). iOPTIMA INT and Integrated Dental Unit Platform (IDUP) are dental chair’s integrated device allowing the control of dental and surgical micromotors parameters (such as torque, speed, and direction of rotation), irrigation pump and dental accessories via a user interface. For iOptima INT devices, the user interface is and Apple Device.
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
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EIA | Unit, Operative Dental | Dental | 872.6640 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41264 | Surgical power tool system control unit, line-powered | A mains electricity (AC-powered) component of a line-powered surgical/dental power tool system intended to step down the electrical power from the mains to supply the handpiece/motor (not included), and may also be intended to regulate some of the functions of the connected power tools (e.g., speed and torque); it may be intended for single or multiple clinical applications (i.e., dedicated or non-dedicated). This device may have integrated irrigation functionality and may be operated through hand and/or foot controls. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | J00716011960051 | HIBCC |