510(k) K102821
K102821 is an FDA 510(k) premarket notification submitted by Phoenix Dental, Inc. for the device "DISCOVRED". The FDA issued a decision of Substantially Equivalent on March 11, 2011. The device falls under product code LFC (Device, Caries Detection), a Class II device regulated under 21 CFR 872.1740. Phoenix Dental, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 11, 2011
- Date Received
- September 28, 2010
- 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