Not currently registered with FDA under this name
Biolase Technology, Inc.
Clemente, CA, United States. Named as applicant on 6 dental 510(k) clearances between 1998 and 2003. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 61998–2003
- Markets registered in
- 312 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1990–2026
Registered in 3 markets
Where regulators' registries name Biolase Technology, Inc. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | Biolase Technology, Inc. | 6 clearances | 1998–2003 | Below |
| South Korea | MFDS | Manufacturer | Biolase Technology, IncBIOLASE Technology, Inc. · Biolase Technology, Inc. · +1 | 9 | 2003–2013 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | BIOLASE TECHNOLOGY, INC. | 3 | 2006–2008 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
510(k) clearances
Clearances on which FDA names Biolase Technology, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 3 Feb 2003 | K022803 | WATERLASE FOR APICOECTOMY | MXF Caries Removal & Cavity Preparation Hydrokinetic Dental System |
| 12 Feb 2002 | K013908 | WATERLASE MILLENNIUM | MXF Caries Removal & Cavity Preparation Hydrokinetic Dental System |
| 18 Jan 2002 | K012511 | WATERLASE MILLENNIUM | MXF Caries Removal & Cavity Preparation Hydrokinetic Dental System |
| 14 Apr 2000 | K000290 | LAZERSMILE, LAZERWHITE | EFW Manual Toothbrush |
| 24 Feb 1999 | K990219 | MODIFICATION OF MILLENNIUM | MXF Caries Removal & Cavity Preparation Hydrokinetic Dental System |
| 8 Oct 1998 | K980585 | MILLENNIUM | EFB Dental Air-Powered Handpiece |
Sources
FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.