Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dentsply International, Inc. — Predicate Candidate Screening
36 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
104 daysmedian FDA review time
237 days90th percentile
36clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K160207 | ATLANTIS ISUS Implant Suprastructures | Dentsply International, Inc. | 2016-09-21 | 237 | 0 |
| K160232 | Disposable Barrier Sleeves and Covers | Dentsply International, Inc. | 2016-06-07 | 127 | 0 |
| K151439 | ATLANTIS ISUS | Dentsply International, Inc. | 2016-02-19 | 266 | 0 |
| K152247 | ATLANTIS Crown | Dentsply International, Inc. | 2016-01-29 | 172 | 0 |
| K151039 | ATLANTIS Abutment for NobelActive 3.0 | Dentsply International, Inc. | 2016-01-14 | 269 | 0 |
| K151619 | Prime&Bond Elect Universal Dental Adhesive | Dentsply International, Inc. | 2015-10-30 | 136 | 0 |
| K150535 | Cavitron Touch Ultrasonic Scaling System | Dentsply International, Inc. | 2015-06-16 | 105 | 0 |
| K142178 | PROROOT MTA WHITE, PROROOT MTA GRAY | Dentsply International, Inc. | 2015-02-26 | 202 | 0 |
| K131907 | RAYPEX 6 | Dentsply International, Inc. | 2014-01-31 | 219 | 0 |
| K131644 | ANKYLOS SYNCONE ABUTMENT 5(DEGREE) | Dentsply International, Inc. | 2014-01-22 | 231 | 0 |
| K132145 | MTM(R) CLEAR ALIGNER | Dentsply International, Inc. | 2013-10-11 | 92 | 0 |
| K122424 | ISUS IMPLANT SUPRASTRUCTURES | Dentsply International, Inc. | 2013-07-05 | 330 | 0 |
| K123925 | MTM CLEAR ALIGNER IN-OFFICE | Dentsply International, Inc. | 2013-05-24 | 155 | 0 |
| K122331 | CAVITY VARNISH | Dentsply International, Inc. | 2012-10-15 | 74 | 0 |
| K121698 | NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN | Dentsply International, Inc. | 2012-08-06 | 59 | 0 |
| K113406 | AQUASIL ULTRA SMART WETTING IMPRESSION MATERIAL | Dentsply International, Inc. | 2012-02-13 | 87 | 0 |
| K112152 | CERCON HT | Dentsply International, Inc. | 2011-11-09 | 105 | 0 |
| K110753 | MIDWEST RDH FREEDOM CORDLESS PROPHY SYSTEM | Dentsply International, Inc. | 2011-06-06 | 80 | 0 |
| K103653 | E3 TORQUE CONTROL MOTOR | Dentsply International, Inc. | 2011-05-26 | 164 | 0 |
| K101493 | ADVANCED GLASS IONOMER (K-130) RESTORATIVE | Dentsply International, Inc. | 2010-08-19 | 79 | 0 |
| K091706 | QUATTRO PORCELAIN SYSTEM | Dentsply International, Inc. | 2009-08-28 | 79 | 0 |
| K083841 | ADAPTABLE COMPOSITE RESIN RESTORATIVE MATERIAL | Dentsply International, Inc. | 2009-04-14 | 111 | 0 |
| K083326 | FLUOROCORE 2 | Dentsply International, Inc. | 2009-02-10 | 90 | 0 |
| K073075 | FRIALIT PLUS, XIVE S PLUS, XIVE TG PLUS, ANKYLOS PLUS, DENTA | Dentsply International, Inc. | 2008-03-31 | 152 | 0 |
| K073067 | ANKYLOS DENTAL IMPLANT SYSTEM/CLAIMS | Dentsply International, Inc. | 2008-02-15 | 108 | 0 |
| K073073 | ANKYLOS TEMPORARY ABUTMENT BALANCE | Dentsply International, Inc. | 2008-02-12 | 104 | 0 |
| K072522 | THERMOFORM SHEET MATERIALS AND ACCESSORIES | Dentsply International, Inc. | 2007-11-16 | 70 | 0 |
| K072713 | ION DENTAL RESIN SYSTEM | Dentsply International, Inc. | 2007-10-12 | 17 | 0 |
| K072342 | SULTAN TOOTH ROOT DESENSITIZER | Dentsply International, Inc. | 2007-10-03 | 43 | 0 |
| K072052 | OSTEOGRAF/D-300 | Dentsply International, Inc. | 2007-08-08 | 13 | 0 |
| K072056 | OSTEOGRAF/D-700 | Dentsply International, Inc. | 2007-08-06 | 11 | 0 |
| K072057 | OSTEOGRAF/LD-300 | Dentsply International, Inc. | 2007-08-06 | 11 | 0 |
| K070307 | STERI -MATE HANDPIECE SLEEVE WITH LED LIGHT | Dentsply International, Inc. | 2007-05-02 | 90 | 0 |
| K070306 | PAINT- ON POLISH AGENT | Dentsply International, Inc. | 2007-03-22 | 49 | 0 |
| K061264 | TEMPFX ESTHETIC PROVISIONAL SYSTEM | Dentsply International, Inc. | 2006-05-23 | 18 | 0 |
| K060293 | TEMPORARY CROWN AND BRIDGE MATERIAL | Dentsply International, Inc. | 2006-02-17 | 11 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda