510(k) K042394
K042394 is an FDA 510(k) premarket notification submitted by Kavo America Corporation for the device "DIAGNODENT PERIO TIP (ACCESSORY)". The FDA issued a decision of Substantially Equivalent on August 2, 2005. The device falls under product code NBL (Light-Induced Fluorescence Caries Detector), a Class II device regulated under 21 CFR 872.1745. Kavo America Corporation has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 2, 2005
- Date Received
- September 2, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light-Induced Fluorescence Caries Detector
- Device Class
- Class II
- Regulation Number
- 872.1745
- Review Panel
- DE
- Submission Type