510(k) K012733
K012733 is an FDA 510(k) premarket notification submitted by Kuraray Medical, Inc. for the device "CARIES DETECTOR". The FDA issued a decision of Substantially Equivalent on September 14, 2001. The device falls under product code LFC (Device, Caries Detection), a Class II device regulated under 21 CFR 872.1740. Kuraray Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 14, 2001
- Date Received
- August 14, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Caries Detection
- Device Class
- Class II
- Regulation Number
- 872.1740
- Review Panel
- DE
- Submission Type