510(k) K013908
- Device
- WATERLASE MILLENNIUM
- Applicant
- BIOLASE TECHNOLOGY, INC.
- 510(k) number
- K013908
- Product code
- MXF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-02-12
- Date received
- 2001-11-26
- Regulation
- 872.4120
- Classification name
- System, Dental, Hydrokinetic, Caries Removal & Cavity Preparation
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- IOANA M RIZOIU
- Address
- 981 Calle Amanecer Clemente CA US 92673 92673
FDA Registration Numbers#
- 3017125161
- 2027755
Source Documents#
Other 510(k) Records For Product Code MXF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K022803 | WATERLASE FOR APICOECTOMY | Biolase Technology, Inc. | 2003-02-03 |
| K012511 | WATERLASE MILLENNIUM | Biolase Technology, Inc. | 2002-01-18 |
| K990908 | MILLENNIUM | Endo Technic Corp. | 1999-05-27 |
| K990219 | MODIFICATION OF MILLENNIUM | Biolase Technology, Inc. | 1999-02-24 |
Legacy Summary#
summary
FDA Review#
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