BenTips Insert WPUP2A
- Primary DI
- D966WPUP2A0
- Brand
- BenTips Insert WPUP2A
- Company
- BENNETT JACOBY, DDS, MS, INC.
- Model
- WPUP2A
- Device description
- BenTips Insert WPUP2A
- Published
- 2021-08-17
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
Product Codes#
| Code | Name |
|---|---|
| ELC | Scaler, Ultrasonic |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| ELC | Scaler, Ultrasonic | Dental | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K111290 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| D966WPUP2A0 | Primary | HIBCC | 0 |
GMDN Terms#
| Term | Definition |
|---|---|
| Ultrasonic dental scaling/debridement system handpiece tip, periodontal | An insert intended to be attached to an ultrasonic dental scaling/debridement system handpiece, to transmit ultrasonic energy (e.g., 25 kHz/30 kHz) from a generator to the oral cavity for the removal of accretions from tooth surfaces during dental cleaning or periodontal therapy; it is not intended for endodontic use. This device vibrates at a high frequency to provide the scaling effect. Water or a rinsing solution (e.g., chlorhexidine) is intended to be fed through the handpiece/tip assembly to assist in the process. This device is available in a variety of designs and tip shapes. This is a reusable device. |
Sterilization Methods#
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags#
- DUNS number
- 031283428
- Device count
- 1
- DM exempt
- true
- Lot or batch
- true
- Sterilization required before use
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| D966T15V331 | BenTips Stubby Tri A3 | T15v3.3 | 2022-02-17 | |
| D966T15V501 | BenTips Mod Tri A3 | T15v5.0 | 2022-02-17 | |
| D966T16V301 | BenTips Star A3 | T16v3.0 | 2022-02-17 | |
| D966T18V241 | BenTips OG Quad A | T18v2.4 | 2022-02-17 | |
| D966TTA1 | BenTips TTA | TTA | 2022-02-17 | |
| D966T15V330 | BenTips Stubby Tri A3 | T15v3.3 | 2022-02-17 | |
| D966T15V500 | BenTips Mod Tri A3 | T15v5.0 | 2022-02-17 | |
| D966T16V300 | BenTips Star A3 | T16v3.0 | 2022-02-17 | |
| D966T18V240 | BenTips OG Quad A | T18v2.4 | 2022-02-17 | |
| D966TTA0 | BenTips TTA | TTA | 2022-02-17 | |
| D966S45AV10 | BenTips Shaft 45Av1 | S45Av1 | 2021-11-01 | |
| D966S90AV10 | BenTips Shaft 90Av1 | S90Av1 | 2021-11-01 | |
| D966WPUI3A0 | BenTips Insert WPUI3A | WPUI3A | 2021-08-17 | |
| D966WPUI4A0 | BenTips Insert WPUI4A | WPUI4A | 2021-08-17 | |
| D966WPUI5A0 | BenTips Insert WPUI5A | WPUI5A | 2021-08-17 | |
| D966WPUI6A0 | BenTips Insert WPUI6A | WPUI6A | 2021-08-17 | |
| D966WPUI7A0 | BenTips Insert WPUI7A | WPUI7A | 2021-08-17 | |
| D966WPUP3A0 | BenTips Insert WPUP3A | WPUP3A | 2021-08-17 | |
| D966WPUP4A0 | BenTips Insert WPUP4A | WPUP4A | 2021-08-17 | |
| D966WPUP6A0 | BenTips Insert WPUP6A | WPUP6A | 2021-08-17 |
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