510(k) K955445
K955445 is an FDA 510(k) premarket notification submitted by Danville Engineering, Inc. for the device "CARIES FINDER". The FDA issued a decision of Substantially Equivalent on February 8, 1996. The device falls under product code LFC (Device, Caries Detection), a Class II device regulated under 21 CFR 872.1740. Danville Engineering, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 8, 1996
- Date Received
- November 29, 1995
- 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