Company ยท US
Dentsply International, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2001 to 2016. Name variants (Inc, Corp, punctuation) are merged.
59510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| NHA | Abutment, Implant, Dental, Endosseous | 8 |
| EJT | Alloy, Gold-Based Noble Metal | 5 |
| ELC | Scaler, Ultrasonic | 5 |
| EBF | Material, Tooth Shade, Resin | 4 |
| EIH | Powder, Porcelain | 4 |
| KLE | Agent, Tooth Bonding, Resin | 3 |
| LYC | Bone Grafting Material, Synthetic | 3 |
| DZE | Implant, Endosseous, Root-Form | 2 |
| EBG | Crown And Bridge, Temporary, Resin | 2 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 2 |
| EBZ | Activator, Ultraviolet, For Polymerization | 2 |
| KIF | Resin, Root Canal Filling | 2 |
| LBH | Varnish, Cavity | 2 |
| NXC | Aligner, Sequential | 2 |
| DYW | Bracket, Plastic, Orthodontic | 1 |
| EBC | Sealant, Pit And Fissure, And Conditioner | 1 |
| EBD | Coating, Filling Material, Resin | 1 |
| EBW | Controller, Foot, Handpiece And Cord | 1 |
| EFB | Handpiece, Air-Powered, Dental | 1 |
| EJR | Agent, Polishing, Abrasive, Oral Cavity | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 21, 2016 | K160207 | ATLANTIS ISUS Implant Suprastructures Dentsply International, Inc. | NHA |
| Jun 7, 2016 | K160232 | Disposable Barrier Sleeves and Covers Dentsply International, Inc. | PEM |
| Feb 19, 2016 | K151439 | ATLANTIS ISUS Dentsply International, Inc. | NHA |
| Jan 29, 2016 | K152247 | ATLANTIS Crown Dentsply International, Inc. | EIH |
| Jan 14, 2016 | K151039 | ATLANTIS Abutment for NobelActive 3.0 Dentsply International, Inc. | NHA |
| Oct 30, 2015 | K151619 | Prime&Bond Elect Universal Dental Adhesive Dentsply International, Inc. | KLE |
| Jun 16, 2015 | K150535 | Cavitron Touch Ultrasonic Scaling System Dentsply International, Inc. | ELC |
| Feb 26, 2015 | K142178 | PROROOT MTA WHITE, PROROOT MTA GRAY Dentsply International, Inc. | KIF |
| Jan 31, 2014 | K131907 | RAYPEX 6 Dentsply International, Inc. | LQY |
| Jan 22, 2014 | K131644 | ANKYLOS SYNCONE ABUTMENT 5(DEGREE) Dentsply International, Inc. | NHA |
| Oct 11, 2013 | K132145 | MTM(R) CLEAR ALIGNER Dentsply International, Inc. | NXC |
| Jul 5, 2013 | K122424 | ISUS IMPLANT SUPRASTRUCTURES Dentsply International, Inc. | NHA |
| May 24, 2013 | K123925 | MTM CLEAR ALIGNER IN-OFFICE Dentsply International, Inc. | NXC |
| Dec 11, 2012 | K122268 | ANGLED XIVE MP ABUTMENT, ANGLED ANKYLOS Dentsply International | NHA |
| Oct 15, 2012 | K122331 | CAVITY VARNISH Dentsply International, Inc. | LBH |
| Aug 6, 2012 | K121698 | NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN Dentsply International, Inc. | EJR |
| Feb 13, 2012 | K113406 | AQUASIL ULTRA SMART WETTING IMPRESSION MATERIAL Dentsply International, Inc. | ELW |
| Nov 9, 2011 | K112152 | CERCON HT Dentsply International, Inc. | EIH |
| Jun 6, 2011 | K110753 | MIDWEST RDH FREEDOM CORDLESS PROPHY SYSTEM Dentsply International, Inc. | EKX |
| May 26, 2011 | K103653 | E3 TORQUE CONTROL MOTOR Dentsply International, Inc. | EBW |
| Aug 19, 2010 | K101493 | ADVANCED GLASS IONOMER (K-130) RESTORATIVE Dentsply International, Inc. | EMA |
| Aug 28, 2009 | K091706 | QUATTRO PORCELAIN SYSTEM Dentsply International, Inc. | EIH |
| Apr 14, 2009 | K083841 | ADAPTABLE COMPOSITE RESIN RESTORATIVE MATERIAL Dentsply International, Inc. | EBF |
| Feb 10, 2009 | K083326 | FLUOROCORE 2 Dentsply International, Inc. | EBF |
| Mar 31, 2008 | K073075 | FRIALIT PLUS, XIVE S PLUS, XIVE TG PLUS, ANKYLOS PLUS, DENTAL IMPLANT SYSTEMS Dentsply International, Inc. | DZE |
| Feb 15, 2008 | K073067 | ANKYLOS DENTAL IMPLANT SYSTEM/CLAIMS Dentsply International, Inc. | DZE |
| Feb 12, 2008 | K073073 | ANKYLOS TEMPORARY ABUTMENT BALANCE Dentsply International, Inc. | NHA |
| Nov 16, 2007 | K072522 | THERMOFORM SHEET MATERIALS AND ACCESSORIES Dentsply International, Inc. | MQC |
| Oct 12, 2007 | K072713 | ION DENTAL RESIN SYSTEM Dentsply International, Inc. | EBI |
| Oct 3, 2007 | K072342 | SULTAN TOOTH ROOT DESENSITIZER Dentsply International, Inc. | LBH |
| Aug 8, 2007 | K072052 | OSTEOGRAF/D-300 Dentsply International, Inc. | LYC |
| Aug 6, 2007 | K072057 | OSTEOGRAF/LD-300 Dentsply International, Inc. | LYC |
| Aug 6, 2007 | K072056 | OSTEOGRAF/D-700 Dentsply International, Inc. | LYC |
| May 2, 2007 | K070307 | STERI -MATE HANDPIECE SLEEVE WITH LED LIGHT Dentsply International, Inc. | ELC |
| Mar 22, 2007 | K070306 | PAINT- ON POLISH AGENT Dentsply International, Inc. | EBD |
| Jul 28, 2006 | K061580 | ECLIPSE WAX REMOVER Dentsply International | EBI |
| May 23, 2006 | K061264 | TEMPFX ESTHETIC PROVISIONAL SYSTEM Dentsply International, Inc. | EBG |
| Apr 10, 2006 | K060837 | IN-OVATION C Dentsply International | NJM |
| Mar 29, 2006 | K053368 | INTERPROXIMAL REDUCTION SYSTEM Dentsply International | EFB |
| Feb 17, 2006 | K060293 | TEMPORARY CROWN AND BRIDGE MATERIAL Dentsply International, Inc. | EBG |
| Nov 1, 2005 | K052370 | CP BRACKET SYSTEM Dentsply International | DYW |
| Aug 12, 2005 | K052097 | CERAM X UNIVERSAL MANO-CERAMIC RESTORATIVE Dentsply International | EBF |
| Jun 14, 2005 | K050208 | FRIADENT ESTHETICAP Dentsply International | NHA |
| May 11, 2005 | K050959 | DELTON ILLUMINATING PIT AND FISSURE SEALING Dentsply International | EBC |
| Feb 23, 2005 | K050386 | PRIME & BOND NT DUAL CURE NANO-TECHNOLOGY UNIVERSAL DENTAL ADHESIVE SYSTEM Dentsply International | KLE |
| Jun 24, 2004 | K041372 | SMARTLITE PS PEN-STYLE LED CURING LIGHT Dentsply International | EBZ |
| Jun 16, 2004 | K041343 | XENO NM LIGHT CURED DENTAL ADHESIVE Dentsply International | KLE |
| Jun 16, 2004 | K041335 | PTM SYSTEM Dentsply International | EIH |
| Apr 1, 2004 | K040144 | QUIXX POSTERIOR RESTORATIVE Dentsply International | EBF |
| Dec 4, 2003 | K033705 | BOBCAT PRO SCALER SYSTEM, MODEL G-130 Dentsply International | ELC |
Newest 50 of 59.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||