510(k) K103244
K103244 is an FDA 510(k) premarket notification submitted by Dentsply Intl., Inc. for the device "QMIX 2IN1 ENDODONTIC IRRIGATING SOLUTION". The FDA issued a decision of Substantially Equivalent on February 14, 2011. The device falls under product code KJJ (Cleanser, Root Canal), a Class U device. Dentsply Intl., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 14, 2011
- Date Received
- November 2, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cleanser, Root Canal
- Device Class
- Class U
- Regulation Number
- Review Panel
- DE
- Submission Type