FDA UDI
In Commercial Distribution
🇺🇸 United States
BenTips Piezosurgery Unit
DI: D966BPS1LED0
·
Model: BPS1LED
·
BENNETT JACOBY, DDS, MS, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- BenTips Piezosurgery Unit
- Primary DI
- D966BPS1LED0
- Version / Model
- BPS1LED
- Company Name
- BENNETT JACOBY, DDS, MS, INC.
- Labeler DUNS
- 031283428
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-04-01
- Public Version
- 1
- Public Version Date
- 2021-04-09
- Public Version Status
- New
- Public Device Record Key
- 52a6d109-4ee6-4b62-a025-5451fa0affce
Device Description
BenTips Piezosurgery Control Unit
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 |
|---|---|---|---|---|
| DZI | Drill, Bone, Powered | Dental | 872.4120 | 2 |
| ELC | Scaler, Ultrasonic | Dental | 872.4850 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47013 | Dental ultrasonic surgical system generator | A mains electricity (AC-powered) component of a dental ultrasonic surgical system used to generate a high frequency electrical current that is converted, typically within a handpiece, into an ultrasonic oscillation to mechanically fragment and cut bone upon contact with a vibrating tip during dental surgery, typically in combination with irrigation. It provides the controls and monitoring functions for the system during the procedure, and typically regulates energy to the system via a foot-switch. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D966BPS1LED0 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K111290 | 000 |