FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KAVO POLYLUX II
K Number: K013500
·
Decision Jan 14, 2002
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
213
Applicant Total
20
Review Days
84
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Basic Information
- Device Name
- KAVO POLYLUX II
- K Number
- K013500
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.6070
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kavo America
- Date Received
- October 22, 2001
- Decision Date
- January 14, 2002
- Product Code
- EBZ
- 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 |
|---|---|---|---|
| EBZ | Activator, Ultraviolet, For Polymerization | FDA class 2 | Dental |
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| K032081 | KAVO EVEREST ZS-BLANK MODELS, 42, 20, AND 60 | Jul 24, 2003 | Substantially Equivalent |
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| K024214 | KAVO EVEREST TITANBLANK | Mar 12, 2003 | Substantially Equivalent |