FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MILLENNIUM
K Number: K990908
·
Decision May 27, 1999
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
4
Applicant Total
10
Review Days
70
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Basic Information
- Device Name
- MILLENNIUM
- K Number
- K990908
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4120
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Endo Technic Corp.
- Date Received
- March 18, 1999
- Decision Date
- May 27, 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
Other 510(k) clearances with the same product code (MXF), ordered by most recent decision date.
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WATERLASE MILLENNIUM
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MODIFICATION OF MILLENNIUM
FDA 510(k)
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·Dental
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