System, Dental, Hydrokinetic, Caries Removal & Cavity Preparation
The Hydrokinetic Dental System for Caries Removal and Cavity Preparation uses a pressurized water-abrasive jet to remove decayed tooth structure and prepare cavities without the vibration and heat associated with traditional rotary drills. It is used in dental procedures as an alternative to conventional drilling. Classified as FDA Class 2, it requires 510(k) premarket clearance under regulation 872.4120 (Dental specialty). This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- MXF
- Device Class
- FDA class 2
- Regulation Number
- 872.4120
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K022803 | WATERLASE FOR APICOECTOMY | Feb 03, 2003 | Substantially Equivalent | Biolase Technology, Inc. |
| K013908 | WATERLASE MILLENNIUM | Feb 12, 2002 | Substantially Equivalent | Biolase Technology, Inc. |
| K012511 | WATERLASE MILLENNIUM | Jan 18, 2002 | Substantially Equivalent | Biolase Technology, Inc. |
| K990908 | MILLENNIUM | May 27, 1999 | Substantially Equivalent | Endo Technic Corp. |
| K990219 | MODIFICATION OF MILLENNIUM | Feb 24, 1999 | Substantially Equivalent | Biolase Technology, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.