510(k) K071429
K071429 is an FDA 510(k) premarket notification submitted by Kerr Corporation for the device "TI2200 TRANSILLUMINATION CABLE". The FDA issued a decision of Substantially Equivalent on September 10, 2007. The device falls under product code NTK (Light Transmission Caries Detector), a Class II device regulated under 21 CFR 872.1745. Kerr Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 10, 2007
- Date Received
- May 23, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light Transmission Caries Detector
- Device Class
- Class II
- Regulation Number
- 872.1745
- Review Panel
- DE
- Submission Type