MILLENNIUM
FDA 510(k) clearance K990908 · decided 1999-05-27
Clearance details
- K-number
- K990908
- Device name
- MILLENNIUM
- Applicant
- Endo Technic Corp.
- Decision
- Substantially Equivalent
- Date received
- 1999-03-18
- Decision date
- 1999-05-27
- Days to decision
- 70 days
- Clearance type
- Traditional
- Product code
- MXF
- Device class
- 2
- Regulation number
- 872.4120
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- San 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 |
| MODIFICATION OF MILLENNIUM (K990219) | Biolase Technology, Inc. | 1999-02-24 |
Recalls involving this device
No recalls on record reference this clearance.