Company ยท US
Pulpdent Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1990 to 2021. Name variants (Inc, Corp, punctuation) are merged.
110510(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 | 29 |
| EMA | Cement, Dental | 14 |
| KLE | Agent, Tooth Bonding, Resin | 11 |
| EBC | Sealant, Pit And Fissure, And Conditioner | 10 |
| LBH | Varnish, Cavity | 10 |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | 9 |
| KIF | Resin, Root Canal Filling | 6 |
| EJK | Liner, Cavity, Calcium Hydroxide | 4 |
| EJR | Agent, Polishing, Abrasive, Oral Cavity | 3 |
| EBG | Crown And Bridge, Temporary, Resin | 2 |
| EKJ | Burnisher, Operative | 2 |
| EBD | Coating, Filling Material, Resin | 1 |
| EIE | Dam, Rubber | 1 |
| EKL | Point, Silver, Endodontic | 1 |
| EKM | Gutta-Percha | 1 |
| ELL | Teeth, Porcelain | 1 |
| EME | Punch, Biopsy, Surgical | 1 |
| KJJ | Cleanser, Root Canal | 1 |
| LFC | Device, Caries Detection | 1 |
| LQY | Locator, Root Apex | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 22, 2021 | K210045 | ACTIVA PRESTO PACK Pulpdent Corporation | EBF |
| Jan 17, 2018 | K173020 | OBA-MCP, Orthodontic Bracket Adhesive with MCP Pulpdent Corporation | DYH |
| Jan 5, 2018 | K172169 | Pulpdent (Activa) Pit and Fissure Sealant with MCP Pulpdent Corporation | EBC |
| Apr 1, 2016 | K153249 | Pulpdent Solo Flowable Composite with MCP Pulpdent Corporation | EBF |
| Mar 29, 2013 | K130223 | RMGI FILL Pulpdent Corporation | EMA |
| Dec 7, 2012 | K123265 | RMGI LOW VISCOSITY Pulpdent Corporation | EMA |
| Jun 8, 2012 | K120784 | TUFF-TEMP 2.0 Pulpdent Corporation | EBG |
| Apr 5, 2012 | K120003 | NUCAL Pulpdent Corporation | EJK |
| Mar 30, 2012 | K120213 | ETCH-RITE SUPREME Pulpdent Corporation | KLE |
| Mar 21, 2012 | K113818 | EMBRACE WETBOND PIT AND FISSURE SEALANT, LOW FILL Pulpdent Corporation | EBC |
| Mar 5, 2012 | K113711 | LIME-LITE II Pulpdent Corporation | EJK |
| Mar 2, 2012 | K113617 | SPEE-DEE PATCH Pulpdent Corporation | EBF |
| Dec 9, 2011 | K112946 | ACTIV VARNISH Pulpdent Corporation | LBH |
| May 12, 2010 | K100503 | PULPDENT COPAL VARNISH WITH FLUORIDE Pulpdent Corporation | LBH |
| Mar 10, 2010 | K093620 | PULPDENT FLUORIDE VARNISH Pulpdent Corporation | LBH |
| May 21, 2009 | K090457 | ORALUBE Pulpdent Corporation | ONK |
| May 11, 2009 | K090391 | PULPDENT MICRO-HYBRID COMPOSITE Pulpdent Corporation | EBF |
| Sep 17, 2008 | K081810 | PULPDENT TEMPORARY CROWN AND BRIDGE MATERIAL Pulpdent Corporation | EBG |
| Jun 29, 2007 | K071278 | EMBRACE DUAL CURE COMPOSITE MATERIALS Pulpdent Corporation | EBF |
| Feb 8, 2006 | K052281 | EMBRACE WETBOND CLEAR SEALANT Pulpdent Corporation | EBC |
| Apr 20, 2004 | K040236 | PULPDENT VLC RESIN CEMENT Pulpdent Corporation | EMA |
| Dec 10, 2003 | K032953 | EMBRACE WETBOND RESTORATION AND PFM REPAIR KIT Pulpdent Corporation | KLE |
| Aug 5, 2003 | K031915 | PULPDENT ETCH-RITE ROYALE Pulpdent Corporation | KLE |
| Aug 1, 2003 | K031877 | EMBRACE WET-BOND RESTORATIVE MATERIAL Pulpdent Corporation | EBF |
| Mar 12, 2003 | K030036 | TRIPLE-CURE PASTE/PASTE RESIN-REINFORCED GLASS IONOMER CEMENT Pulpdent Corporation | DYH |
| Oct 11, 2002 | K022492 | PULPDENT SEMI-GEL ETCH Pulpdent Corporation | EBF |
| Oct 7, 2002 | K022734 | PULPDENT CALCIUM HYDROXIDE PREPARATION Pulpdent Corporation | KIF |
| Sep 26, 2002 | K022522 | PULPDENT PUTTY DAM Pulpdent Corporation | EIE |
| May 16, 2002 | K020514 | PULPDENT GLAZE II Pulpdent Corporation | KLE |
| Apr 17, 2002 | K020481 | PULPDENT POST CEMENT Pulpdent Corporation | EMA |
| Apr 17, 2002 | K020432 | PULPDENT GLAZE Pulpdent Corporation | EBF |
| Apr 12, 2002 | K020287 | DENTITION INTEGRATING MATERIAL Pulpdent Corporation | EBC |
| Mar 14, 2002 | K014138 | PULPDENT TRIPLE-CURE REINFORCED GLASS IONOMER ORTHODONTIC CEMENT Pulpdent Corp. | DYH |
| Mar 14, 2002 | K014133 | PULPDENT NO-MIX ORTHODONTIC BRACKET ADHESIVE Pulpdent Corp. | DYH |
| Feb 28, 2002 | K020115 | PULPDENT SEALANT/PASTE ORTHODONTIC BRACKET ADHESIVE SYSTEM Pulpdent Corp. | DYH |
| Feb 27, 2002 | K014059 | PULPDENT TRANS OBA ORTHODONTIC BRACKET ADHESIVE Pulpdent Corp. | DYH |
| Dec 12, 2001 | K013411 | PULPDENT CAVITY PREPARATION IV Pulpdent Corp. | LBH |
| Mar 2, 2000 | K994180 | PULPDENT CAVITY PREPARATION III Pulpdent Corp. | LBH |
| Feb 29, 2000 | K994181 | PULPDENT CAVITY PREPARATION II, PULPDENT CAVITY PREPARATION II WUTH FLUORIDE Pulpdent Corp. | LBH |
| Feb 23, 2000 | K994182 | PULPDENT CAVITY PREPARATION 1, PULPDENT CAVITY PREPARATION 1 WITH FLUORIDE Pulpdent Corp. | LBH |
| Dec 13, 1999 | K993683 | PULPDENT UNO-DUO Pulpdent Corp. | KLE |
| Mar 19, 1998 | K974202 | PULPDENT CAVITY CLEANSER, PULPDENT CAVITY CLEANSER PLUS Pulpdent Corp. | LBH |
| Feb 18, 1998 | K974398 | PULPDENT CAVITY VARNISH Pulpdent Corp. | LBH |
| Dec 17, 1997 | K974014 | PULPDENT DENTASTIC UNO Pulpdent Corp. | EMA |
| Oct 2, 1997 | K972445 | PULPDENT OX-OUT Pulpdent Corp. | EMA |
| Sep 12, 1997 | K971594 | FLOW-RITE Pulpdent Corp. | EBF |
| Jan 17, 1997 | K964430 | PULPDENT SNOOP Pulpdent Corp. | LFC |
| Nov 12, 1996 | K963921 | PULPDENT SEAL-RITE UDMA Pulpdent Corp. | EBC |
| Oct 11, 1996 | K963652 | PULPDENT DESENSITIZER Pulpdent Corp. | EBF |
| Sep 30, 1996 | K962747 | PULPDENT ENDODONTIC POST CEMENT KIT Pulpdent Corp. | EMA |
Newest 50 of 110.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||