FDA UDI
In Commercial Distribution
🇺🇸 United States
WIRELESS FOOTCTRL + DONGLE
DI: J00716011920011
·
Model: 1601192-001
·
Bien-Air Dental SA
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- WIRELESS FOOTCTRL + DONGLE
- Primary DI
- J00716011920011
- Version / Model
- 1601192-001
- Catalog Number
- 1601192-001
- Company Name
- Bien-Air Dental SA
- Labeler DUNS
- 480082080
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-02-20
- Public Version
- 1
- Public Version Date
- 2025-02-28
- Public Version Status
- New
- Public Device Record Key
- fbb47d86-4adc-425c-952a-149d0fb27587
Device Description
Used to controle the console used in dentistry for implantology, dental surgery and endodontic work.
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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EBW | Controller, Foot, Handpiece And Cord | Dental | 872.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36336 | Foot-switch, electrical | An electrically-powered pedal used by an operator of a medical device to regulate the activation and/or intensity of a parent device (e.g., electrosurgical system generator, laser, ophthalmic examination unit, dental drill/saw system control unit) to which it is connected, typically via an electrical cable. This is a reusable device. | No | Active |
| 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 | J00716011920011 | HIBCC |
Customer Contacts
- Phone
- +1 949-477-6050
- [email protected]