The following data is part of a premarket notification filed by Biolase Technology, Inc. with the FDA for Modification Of Millennium.
| Device ID | K990219 |
| 510k Number | K990219 |
| Device Name: | MODIFICATION OF MILLENNIUM |
| Classification | System, Dental, Hydrokinetic, Caries Removal & Cavity Preparation |
| Applicant | BIOLASE TECHNOLOGY, INC. 981 CALLE AMANECER San Clemente, CA 92673 |
| Contact | Andrew Kimmel |
| Correspondent | Andrew Kimmel BIOLASE TECHNOLOGY, INC. 981 CALLE AMANECER San Clemente, CA 92673 |
| Product Code | MXF |
| CFR Regulation Number | 872.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-22 |
| Decision Date | 1999-02-24 |
| Summary: | summary |