FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
WATERLASE FOR APICOECTOMY
K Number: K022803
·
Decision Feb 3, 2003
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
4
Applicant Total
31
Review Days
164
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- WATERLASE FOR APICOECTOMY
- K Number
- K022803
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4120
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biolase Technology, Inc.
- Date Received
- August 23, 2002
- Decision Date
- February 3, 2003
- Product Code
- MXF
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MXF | System, Dental, Hydrokinetic, Caries Removal & Cavity Preparation | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MXF), ordered by most recent decision date.
WATERLASE MILLENNIUM
FDA 510(k)
FDA Class 2
·Dental
WATERLASE MILLENNIUM
FDA 510(k)
FDA Class 2
·Dental
MILLENNIUM
FDA 510(k)
FDA Class 2
·Dental
MODIFICATION OF MILLENNIUM
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Biolase Technology, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K122368 | WATERLASE IPLUS ALL TISSUE LASER | May 2, 2013 | Substantially Equivalent |
| K130465 | EPIC 10S | Apr 11, 2013 | Substantially Equivalent |
| K121327 | DIOLASE 10S | Feb 1, 2013 | Substantially Equivalent |
| K121286 | EPIC 10 | Sep 28, 2012 | Substantially Equivalent |
| K101658 | WATERLASE MD TURBO PLUS MODEL 7200XXX | Aug 11, 2010 | Substantially Equivalent |
| K093852 | EZLASE 3 LASER SYSTEM | Mar 12, 2010 | Substantially Equivalent |
| K091746 | WATERLASE MD, MODEL 7100102 | Dec 7, 2009 | Substantially Equivalent |
| K083927 | WATERLASE MD | Oct 1, 2009 | Substantially Equivalent |
| K091922 | WATERLASE C100, MODEL 7100104 | Jul 14, 2009 | Substantially Equivalent |
| K083595 | EZLASE | Apr 14, 2009 | Substantially Equivalent |