510(k) K000140
K000140 is an FDA 510(k) premarket notification submitted by The Precident Group for the device "CLINI-DENT". The FDA issued a decision of Substantially Equivalent on May 3, 2000. The device falls under product code MAU (Eraser, Dental Stain), a Class I device regulated under 21 CFR 872.6855.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 3, 2000
- Date Received
- January 18, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Eraser, Dental Stain
- Device Class
- Class I
- Regulation Number
- 872.6855
- Review Panel
- DE
- Submission Type