Company ยท US
Dentsply Intl.
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 2014. Name variants (Inc, Corp, punctuation) are merged.
291510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| EBF | Material, Tooth Shade, Resin | 28 |
| EIH | Powder, Porcelain | 23 |
| KLE | Agent, Tooth Bonding, Resin | 20 |
| EMA | Cement, Dental | 19 |
| ELW | Material, Impression | 18 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 16 |
| ELC | Scaler, Ultrasonic | 13 |
| EBC | Sealant, Pit And Fissure, And Conditioner | 11 |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | 8 |
| EFB | Handpiece, Air-Powered, Dental | 8 |
| LBH | Varnish, Cavity | 6 |
| EBH | Material, Impression Tray, Resin | 5 |
| EBZ | Activator, Ultraviolet, For Polymerization | 5 |
| EJH | Alloy, Metal, Base | 5 |
| EJR | Agent, Polishing, Abrasive, Oral Cavity | 5 |
| ELL | Teeth, Porcelain | 5 |
| KIF | Resin, Root Canal Filling | 5 |
| EHD | Unit, X-Ray, Extraoral With Timer | 4 |
| EJK | Liner, Cavity, Calcium Hydroxide | 4 |
| EJT | Alloy, Gold-Based Noble Metal | 4 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 20, 2014 | K140347 | ANKYLOS C/X IMPLANT SYSTEM Dentsply Intl., Inc. | DZE |
| Jul 23, 2013 | K130862 | CAVITRON PROPHY-JET AIR POLISHING PROPHYLAXIS SYSTEM Dentsply Intl., Inc. | ELC |
| Feb 22, 2013 | K123615 | IRIS - HIGH STRENGTH GLASS CERAMIC Dentsply Intl. | EIH |
| Feb 14, 2011 | K103244 | QMIX 2IN1 ENDODONTIC IRRIGATING SOLUTION Dentsply Intl., Inc. | KJJ |
| Oct 30, 2009 | K093221 | PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION II Dentsply Intl., Inc. | DYH |
| May 22, 2009 | K083805 | ANKYLOS C/X DENTAL IMPLANT SYSTEM Dentsply Intl., Inc. | DZE |
| Oct 29, 2008 | K082198 | DURASHIELD PLUS Dentsply Intl., Inc. | LBH |
| Mar 27, 2008 | K072730 | FRIADENT CERCON AND ANKYLOS CERCON BALANCE ABUTMENTS Dentsply Intl. | NHA |
| Jan 28, 2008 | K072989 | AXIS SYSTEM Dentsply Intl., Inc. | EFB |
| Dec 19, 2007 | K073117 | DENTIN DESENSITIZER AGENT Dentsply Intl., Inc. | LBH |
| Mar 14, 2007 | K070538 | XP BOND DUAL CURE UNIVERSAL TOTAL ETCH ADHESIVE Dentsply Intl. | KLE |
| Jan 26, 2007 | K070019 | CARRARA VOLUMIA Dentsply Intl. | EIH |
| Nov 27, 2006 | K062828 | MOUTHGUARD AND ALIGNER MATERIALS Dentsply Intl., Inc. | MQC |
| Oct 27, 2006 | K060836 | VISTADENT OC - VERSION 4 Dentsply Intl., Inc. | LLZ |
| Jun 26, 2006 | K061427 | PRE-IMPRESSION CONDITIONING SOLUTION Dentsply Intl. | ELW |
| Dec 8, 2005 | K053167 | BIOPURE MTAD ROOT CANAL CLEANSER Dentsply Intl., Inc. | KJJ |
| Nov 22, 2005 | K053010 | VISTADENT AT COMPLETE, MODEL 3.1 Dentsply Intl., Inc. | LLZ |
| Sep 2, 2005 | K052334 | CAVITRON RF ULTRASONIC SCALER SYSTEM WITH STERIMATE HANDPIECE, MODEL G-131 Dentsply Intl. | ELC |
| Jul 15, 2005 | K051707 | ECLIPSE BONDING AGENT Dentsply Intl. | KLE |
| Jul 12, 2005 | K051463 | XENO ADHESIVE WITH ACTIVATOR Dentsply Intl. | KLE |
| Jun 24, 2005 | K051462 | MODIFICATION TO: CERCON BASE Dentsply Intl. | EIH |
| Apr 22, 2005 | K050880 | DYRACT EXTRA RESTORATIVE Dentsply Intl. | EBF |
| Apr 6, 2005 | K050750 | LC BRACKET ADHESIVE SYSTEM Dentsply Intl. | DYH |
| Dec 22, 2004 | K043247 | DUCERA ALLCERAM Dentsply Intl. | EIH |
| Nov 4, 2004 | K042905 | NEO-CLIP ORTHODONTIC BRACKET ACCESSORY Dentsply Intl. | NJM |
| Oct 18, 2004 | K041272 | DYRACT CEM PLUS CEMENT Dentsply Intl. | EMA |
| Aug 30, 2004 | K042178 | ORTHODONTIC CERAMIC BRACKETS Dentsply Intl. | NJM |
| Jul 30, 2004 | K041707 | CERCON CERAM EXPRESS CERAMIC SYSTEM Dentsply Intl. | EIH |
| Jun 16, 2004 | K041141 | DENTSPLY CAVITRON JET WAVE AIR POLISHING PROPHYLAXIS SYSTEM, MODEL G125 Dentsply Intl. | EFB |
| Jun 16, 2004 | K040906 | CALIBRA CEMENT Dentsply Intl. | EMA |
| May 21, 2004 | K040895 | INTEGRITY TEMPORARY CEMENT Dentsply Intl. | EMA |
| Apr 2, 2004 | K040375 | IDEAL 1 ORTHODONTIC BAND CEMENT Dentsply Intl. | DYH |
| Mar 30, 2004 | K040635 | CARRARA INTERACTION CERAMIC SYSTEM Dentsply Intl. | EIH |
| Mar 18, 2004 | K040421 | DUCERAGOLD PORCELAINS Dentsply Intl. | EIH |
| Mar 18, 2004 | K040420 | DUCERAM PLUS CERAMIC SYSTEM Dentsply Intl. | EIH |
| Feb 6, 2004 | K033703 | IDEAL 1 ORTHODONTIC BRACKET ADHESIVE Dentsply Intl. | DYH |
| Jan 23, 2004 | K033667 | CARRARA PRESS SYSTEM Dentsply Intl. | EIH |
| Jan 12, 2004 | K032361 | ENDOPURE ROOT CANAL CLEANSER Dentsply Intl. | KJJ |
| Dec 2, 2003 | K033553 | PFZ PORCELAIN SYSTEM Dentsply Intl. | EIH |
| Oct 14, 2003 | K032904 | ACUCAM CONCEPT IV FWT, MODEL 110-0185G1 Dentsply Intl. | EIA |
| Oct 1, 2003 | K024133 | CLS-2000 UNIT Dentsply Intl. | FLE |
| Sep 30, 2003 | K032317 | ORION GX ALLOY Dentsply Intl. | EJT |
| Sep 30, 2003 | K032316 | ORION E ALLOY Dentsply Intl. | EJT |
| Sep 26, 2003 | K032892 | MODIFICATION TO TRUBYTE DENTURE BASE RESIN SYSTEM Dentsply Intl. | EBI |
| Sep 15, 2003 | K031932 | FLUORIDE VARNISH Dentsply Intl. | LBH |
| Aug 5, 2003 | K031461 | CARRIER TIPS Dentsply Intl. | ELC |
| Jul 15, 2003 | K031145 | ESTYLUS ELECTRIC MOTOR SYSTEM Dentsply Intl. | EFB |
| Jan 23, 2003 | K023776 | XENO III DENTAL ADHESIVE Dentsply Intl. | KLE |
| Sep 6, 2002 | K022796 | CERCON CERAM S PORCELAIN Dentsply Intl. | EIH |
| Aug 19, 2002 | K021805 | SEAL & PROTECT PROTECTIVE SEALANT Dentsply Intl. | LBH |
Newest 50 of 291.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||