Proxeo ULTRA PB-520
- Primary DI
- J021303240001
- Brand
- Proxeo ULTRA PB-520
- Company
- W & H Dentalwerk Bürmoos GmbH
- Model
- 30324000
- Device description
- Ultrasonic scaler drive unit
- Published
- 2023-07-19
- 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 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| J021303240000 | Direct Marking | HIBCC | 0 | |
| J021303240001 | Primary | HIBCC | 0 |
GMDN Terms#
| Term | Definition |
|---|---|
| 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. |
Regulatory Flags#
- DUNS number
- 300238441
- Device count
- 1
- Serial number
- true
- Manufacturing date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| J021122275011 | EB-75 Endea 16:1 | 12227501 | 2018-08-31 | |
| J021122279011 | EB-79 Endea 2:1 | 12227901 | 2018-08-31 | |
| J021300010031 | TG-98 L Megagen | 30001003 | 2022-03-30 | |
| J021300040031 | TG-97 L Megagen | 30004003 | 2022-03-30 | |
| J021301040001 | AM-25 A BC Air Motor | 30104000 | 2023-07-11 | |
| J021301120001 | AM-25 BC Air Motor | 30112000 | 2023-07-11 | |
| J021302120011 | WG-57 LT | 30212001 | 2023-07-11 | |
| J021302180001 | WK-66 LT S | 30218000 | 2019-09-10 | |
| J021303100021 | Assistina Twin MB-302 | 30310002 | 2022-11-29 | |
| J021303980021 | MB-301 Assistina ONE | 30398002 | 2022-08-24 | |
| J021078122001 | Tip Set: 1E, 2E, 3E, 4E, 5E, 6E | 07812200 | 2023-08-14 | |
| J021058492011 | Scaler Tip 4U | 05849201 | 2023-07-19 | |
| J021058494011 | Scaler Tip 1R | 05849401 | 2023-07-19 | |
| J021063680001 | Scaler Tip 2E | 06368000 | 2023-07-19 | |
| J021063684001 | Scaler Tip 2R | 06368400 | 2023-07-19 | |
| J021063685001 | Scaler Tip 3Rm | 06368500 | 2023-07-19 | |
| J021063686001 | Scaler Tip 3Rd | 06368600 | 2023-07-19 | |
| J021078123001 | Scaler Tip 4E | 07812300 | 2023-07-19 | |
| J021078124001 | Scaler Tip 5E | 07812400 | 2023-07-19 | |
| J021079656001 | Scaler Tip 5P | 07965600 | 2023-07-19 |
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| 07630392912617 | BioSonic | Dent4You AG | ELC | 2026-04-06 |
| 07630392912624 | BioSonic | Dent4You AG | ELC | 2026-04-06 |
| 07630392912631 | BioSonic | Dent4You AG | ELC | 2026-04-06 |
| 07630392912648 | BioSonic | Dent4You AG | ELC | 2026-04-06 |
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| 07613353335113 | PIEZON | E.M.S. Electro Medical Systems S.A. | ELC | 2025-10-21 |
| 07613353341404 | Piezon | E.M.S. Electro Medical Systems S.A. | ELC | 2025-10-21 |
| 07613353257224 | AIR-FLOW-PIEZON | E.M.S. Electro Medical Systems S.A. | ELC | 2025-10-20 |
| 07613353257323 | AIR-FLOW-PIEZON | E.M.S. Electro Medical Systems S.A. | ELC | 2025-10-20 |
| 07613353257576 | AIR-FLOW-PIEZON | E.M.S. Electro Medical Systems S.A. | ELC | 2025-10-20 |
| 07613353258061 | AIR-FLOW | E.M.S. Electro Medical Systems S.A. | ELC | 2025-10-20 |
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| 10810000521552 | Parkell® | PARKELL, INC. | ELC | 2023-10-20 |
| J021303230001 | Proxeo ULTRA PB-510 | W & H Dentalwerk Bürmoos GmbH | ELC | 2023-07-19 |
| J021303250001 | Proxeo ULTRA PB-530 | W & H Dentalwerk Bürmoos GmbH | ELC | 2023-07-19 |
| J021303260001 | Proxeo ULTRA Handpiece PB-5 L | W & H Dentalwerk Bürmoos GmbH | ELC | 2023-07-19 |
| J021303270001 | Proxeo ULTRA Handpiece PB-5 L Q | W & H Dentalwerk Bürmoos GmbH | ELC | 2023-07-19 |
| J021303280001 | Proxeo ULTRA Handpiece PB-5 L S | W & H Dentalwerk Bürmoos GmbH | ELC | 2023-07-19 |
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| J021303630001 | EXP-PD-ST-00 (Pump Controller) | W & H Dentalwerk Bürmoos GmbH | ELC | 2023-07-19 |
| J021303440001 | APP-HC-03-XX-00 (Head Controller) | W & H Dentalwerk Bürmoos GmbH | ELC | 2023-07-19 |
| J021303470001 | IFB-DC-CO.CO-HS-00 (Interface Board) | W & H Dentalwerk Bürmoos GmbH | ELC | 2023-07-19 |
| J021303480001 | RFB-03-0200-00 (Rectifier-Board) | W & H Dentalwerk Bürmoos GmbH | ELC | 2023-07-19 |
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