Dentsply International, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 59
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K160207 | ATLANTIS ISUS Implant Suprastructures | September 21, 2016 |
| K160232 | Disposable Barrier Sleeves and Covers | June 7, 2016 |
| K151439 | ATLANTIS ISUS | February 19, 2016 |
| K152247 | ATLANTIS Crown | January 29, 2016 |
| K151039 | ATLANTIS Abutment for NobelActive 3.0 | January 14, 2016 |
| K151619 | Prime&Bond Elect Universal Dental Adhesive | October 30, 2015 |
| K150535 | Cavitron Touch Ultrasonic Scaling System | June 16, 2015 |
| K142178 | PROROOT MTA WHITE, PROROOT MTA GRAY | February 26, 2015 |
| K131907 | RAYPEX 6 | January 31, 2014 |
| K131644 | ANKYLOS SYNCONE ABUTMENT 5(DEGREE) | January 22, 2014 |
| K132145 | MTM(R) CLEAR ALIGNER | October 11, 2013 |
| K122424 | ISUS IMPLANT SUPRASTRUCTURES | July 5, 2013 |
| K123925 | MTM CLEAR ALIGNER IN-OFFICE | May 24, 2013 |
| K122268 | ANGLED XIVE MP ABUTMENT, ANGLED ANKYLOS | December 11, 2012 |
| K122331 | CAVITY VARNISH | October 15, 2012 |
| K121698 | NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN | August 6, 2012 |
| K113406 | AQUASIL ULTRA SMART WETTING IMPRESSION MATERIAL | February 13, 2012 |
| K112152 | CERCON HT | November 9, 2011 |
| K110753 | MIDWEST RDH FREEDOM CORDLESS PROPHY SYSTEM | June 6, 2011 |
| K103653 | E3 TORQUE CONTROL MOTOR | May 26, 2011 |