FDA UDI
In Commercial Distribution
🇺🇸 United States
TU Bora 2 LED
DI: J00716011520011
·
Model: 1601152-001
·
Bien-Air Dental SA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- TU Bora 2 LED
- Primary DI
- J00716011520011
- Version / Model
- 1601152-001
- Catalog Number
- 1601152-001
- Company Name
- Bien-Air Dental SA
- Labeler DUNS
- 480082080
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-09-24
- Public Version
- 1
- Public Version Date
- 2021-10-04
- Public Version Status
- New
- Public Device Record Key
- c84219be-ec97-4215-bc77-5f351da9c974
Device Description
Turbine type high- speed handpiece. Unit supplied by a hose, via a special ISO 9168 coupling. Anti- heat push- button bur changing mechanism. Ceramic ball bearings, 4 sprays. Optical glass rod with light.
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 |
|---|---|---|---|---|
| EFB | Handpiece, Air-Powered, Dental | Dental | 872.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40958 | Dental power tool system handpiece, pneumatic | A hand-held dental device that includes a chuck for attaching a rotary dental endpiece (e.g., drill bits, burs, reamers) intended to be used in dentistry to bore/excavate bones, teeth, and tough tissues. The device incorporates a small turbine motor normally driven by compressed air, and which typically has a built-in water spray for cooling the rotating device; the endpiece(s) are not included. The handpiece is typically connected through the dental delivery system or a freestanding independent system. This is a reusable device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | J00716011520011 | HIBCC |
Customer Contacts
- Phone
- 949-477-6050
- [email protected]