FDA UDI
In Commercial Distribution
🇺🇸 United States
High-speed Turbine Handpieces for Single Use
DI: 06970278690057
·
Model: TBY03-DZJ
·
Beijing Dongbo Dental Handpiece Co.,Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- High-speed Turbine Handpieces for Single Use
- Primary DI
- 06970278690057
- Version / Model
- TBY03-DZJ
- Company Name
- Beijing Dongbo Dental Handpiece Co.,Ltd.
- Labeler DUNS
- 544504276
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-12-11
- Public Version
- 1
- Public Version Date
- 2019-01-11
- Public Version Status
- New
- Public Device Record Key
- 2a8b708f-106c-4ae2-b656-895b7d5bdb50
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
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 | 06970278690057 | GS1 | ||||
| Package | 06970278690200 | GS1 | 10 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K172543 | 000 |