ULTRASONIC SCALER, MODELS VARIOS 350 LUX, VARIOS 350 (NO LIGHT), VARIOS 550, VARIOS 150 LUX, VARIOS 150 (NO LIGHT)
FDA 510(k) clearance K031421 · decided 2004-03-26
Clearance details
- K-number
- K031421
- Device name
- ULTRASONIC SCALER, MODELS VARIOS 350 LUX, VARIOS 350 (NO LIGHT), VARIOS 550, VARIOS 150 LUX, VARIOS 150 (NO LIGHT)
- Applicant
- Nakanishi, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-05-05
- Decision date
- 2004-03-26
- Days to decision
- 326 days
- Clearance type
- Traditional
- Product code
- ELC
- Device class
- 2
- Regulation number
- 872.4850
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Schaumburg, IL, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
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|---|
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| BioSonic US200 Ultrasonic Scaler (60034537) (K240801) | Dent4you AG | 2024-07-01 |
| SP NEWTRON CAN-A; MODULE NEWTRON CAN-A EMB; SUPPORT XINETIC; NWT CAN SLIM LED CORD G3 SHORT; NWT CAN SLIM LED CORD G3 LONG (K233922) | Satelec - Acteon Group | 2024-03-11 |
| EDS Calculus Softener TURBO CR (K223340) | Essential Dental Systems, Inc. | 2023-12-11 |
| Ultrasonic Scaler Tips (K230641) | Guilin Refine Medical Instrument Co., Ltd. | 2023-11-21 |
| Proxeo ULTRA (PB-510, PB-520 and PB-530) (K223173) | W&H Dentalwerk Buermoss GmbH | 2023-07-14 |
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Recalls involving this device
No recalls on record reference this clearance.