FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION OF MILLENNIUM
K Number: K990219
·
Decision Feb 24, 1999
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
4
Applicant Total
31
Review Days
33
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Basic Information
- Device Name
- MODIFICATION OF MILLENNIUM
- K Number
- K990219
- 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
- January 22, 1999
- Decision Date
- February 24, 1999
- 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
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MILLENNIUM
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| K121286 | EPIC 10 | Sep 28, 2012 | Substantially Equivalent |
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| 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 |