510(k) K140144
K140144 is an FDA 510(k) premarket notification submitted by Centrix, Inc. for the device "BENDA WEDGE". The FDA issued a decision of Substantially Equivalent on July 8, 2014. The device falls under product code EJB (Handle, Instrument, Dental), a Class I device regulated under 21 CFR 872.4565. Centrix, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 8, 2014
- Date Received
- January 22, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Handle, Instrument, Dental
- Device Class
- Class I
- Regulation Number
- 872.4565
- Review Panel
- DE
- Submission Type