FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIAGNODENT PERIO TIP (ACCESSORY)
K Number: K042394
·
Decision Aug 2, 2005
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
23
Applicant Total
4
Review Days
334
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Basic Information
- Device Name
- DIAGNODENT PERIO TIP (ACCESSORY)
- K Number
- K042394
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.1745
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kavo America Corporation
- Date Received
- September 2, 2004
- Decision Date
- August 2, 2005
- Product Code
- NBL
- 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 |
|---|---|---|---|
| NBL | Laser, Fluorescence Caries Detection | FDA class 2 | Dental |
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