MODIFICATION OF MILLENNIUM
FDA 510(k) clearance K990219 · decided 1999-02-24
Clearance details
- K-number
- K990219
- Device name
- MODIFICATION OF MILLENNIUM
- Applicant
- Biolase Technology, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-01-22
- Decision date
- 1999-02-24
- Days to decision
- 33 days
- Clearance type
- Traditional
- Product code
- MXF
- Device class
- 2
- Regulation number
- 872.4120
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Clemente, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| WATERLASE FOR APICOECTOMY (K022803) | Biolase Technology, Inc. | 2003-02-03 |
| WATERLASE MILLENNIUM (K013908) | Biolase Technology, Inc. | 2002-02-12 |
| WATERLASE MILLENNIUM (K012511) | Biolase Technology, Inc. | 2002-01-18 |
| MILLENNIUM (K990908) | Endo Technic Corp. | 1999-05-27 |
Recalls involving this device
No recalls on record reference this clearance.