FDA Product Code
FDA Product Code ELW — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.3660
510(k) Clearances — 404 records · page 2 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K080882 | CEREC OPTI SPRAY | Sirona Dental Systems GmbH | 2008-04-11 | Traditional | PDF ↗ |
| K080514 | PECD-01 AND PECD QUICK-01 | 3M Espe AG Dental Products | 2008-03-26 | Special | PDF ↗ |
| K080130 | OCCLUFAST CAD | Zhermack S.P.A. | 2008-03-14 | Special | PDF ↗ |
| K073475 | SYSTEM PLUS | Continental Dental Laboratory | 2008-03-10 | Traditional | PDF ↗ |
| K073005 | ELITE GLASS | Zhermack S.P.A. | 2007-12-12 | Traditional | PDF ↗ |
| K072577 | BISICO IMPRESSION SILICONES & ALGINATES | Bisico GmbH & CO KG | 2007-12-05 | Traditional | PDF ↗ |
| K072622 | STANDOUT 2 | Kerr Corp. | 2007-12-04 | Traditional | PDF ↗ |
| K072245 | EMULATE ADVANCED | Cavex Holland BV | 2007-11-08 | Traditional | PDF ↗ |
| K071192 | BLUGOO HD | Lancer Orthodontics, Inc. | 2007-06-22 | Traditional | PDF ↗ |
| K070677 | COLORISE | Zhermack S.P.A. | 2007-05-11 | Traditional | PDF ↗ |
| K070700 | FREEALGIN | Zhermack S.P.A. | 2007-04-25 | Traditional | PDF ↗ |
| K062400 | IMPRESSIX, COLORCHANGE ALGINATE | Cavex Holland BV | 2006-11-16 | Traditional | PDF ↗ |
| K060891 | VIRTUAL | Ivoclar Vivadent, Inc. | 2006-07-17 | Traditional | PDF ↗ |
| K061267 | SIMULATE, COLOR CHANGE ALGINATE | Cavex Holland BV | 2006-07-10 | Traditional | PDF ↗ |
| K061427 | PRE-IMPRESSION CONDITIONING SOLUTION | Dentsply Intl. | 2006-06-26 | Traditional | PDF ↗ |
| K053619 | COLORBITE | Zhermack S.P.A. | 2006-03-01 | Traditional | PDF ↗ |
| K053427 | FRESH, DENTAL IMPRESSION MATERIAL | Exacta Dental Products, Inc. | 2006-01-13 | Traditional | PDF ↗ |
| K051933 | EXPASYL POWER APPLICATOR | Sybron Dental Specialties, Inc. | 2006-01-03 | Traditional | PDF ↗ |
| K052455 | IMPRESSIX | Cavex Holland BV | 2005-11-23 | Traditional | PDF ↗ |
| K053014 | POLY SILOXANE IMPRESSION MATERIAL | Clinician'S Choice Dental Products, Inc. | 2005-11-15 | Traditional | PDF ↗ |
| K053018 | POLY SILOXANE IMPRESSION MATERIAL | Millennium Dental International, Inc. | 2005-11-08 | Traditional | PDF ↗ |
| K052409 | SILGIMIX ALGINATE REPLACEMENT IMPRESSION MATERIAL | Sultan Chemists, Inc. | 2005-10-20 | Traditional | PDF ↗ |
| K052090 | SPLASH! IMPRESSION MATERIAL DEVICE | Discus Dental, Inc. | 2005-08-05 | Traditional | PDF ↗ |
| K051797 | FUTURE WASH/YPS | 3M Espe AG Dental Products | 2005-07-21 | Special | PDF ↗ |
| K050417 | ELITE IMPLANT | Zhermack S.P.A. | 2005-07-19 | Traditional | PDF ↗ |
| K051424 | HYDROGUM 5 | Zhermack S.P.A. | 2005-07-15 | Traditional | PDF ↗ |
| K051535 | MODIFICATION TO:REGISTRADO X-TRA | Voco GmbH | 2005-06-28 | Special | PDF ↗ |
| K051243 | JET BLUE BITE | Coltene/Whaledent AG | 2005-06-23 | Traditional | PDF ↗ |
| K051207 | CAVEX ORTHOTRACE | Cavex Holland BV | 2005-06-21 | Traditional | PDF ↗ |
| K050604 | KERR VPS IMPRESSION MATERIAL | Sybron Dental Specialties, Inc. | 2005-04-15 | Traditional | PDF ↗ |
| K043493 | FUSION PUTTY TYPE | GC America, Inc. | 2005-03-04 | Traditional | PDF ↗ |
| K043054 | GENIE MAGIC MIX ULTRA HYDROPHILIC IMPRESSION MATERIAL | Sultan Chemists, Inc. | 2005-02-18 | Traditional | PDF ↗ |
| K050013 | RETRACTOFOAM | Coltene/Whaledent AG | 2005-02-09 | Traditional | PDF ↗ |
| K043471 | FUSION FAST | GC America, Inc. | 2005-01-27 | Traditional | PDF ↗ |
| K043118 | HYDROGUM SOFT | Zhermack S.P.A. | 2005-01-24 | Traditional | PDF ↗ |
| K042878 | FLEXITIME XTREME | Heraeus Kulzer, Inc. | 2004-12-17 | Traditional | PDF ↗ |
| K043131 | TORPICALGIN | Zhermack S.P.A. | 2004-12-15 | Traditional | PDF ↗ |
| K042860 | CORRECT DENTAL IMPRESSION MATERIAL | Handae Chemical Co., Ltd. | 2004-12-03 | Traditional | PDF ↗ |
| K041398 | GC FUSION | GC America, Inc. | 2004-06-25 | Traditional | PDF ↗ |
| K041229 | MULTIPLE (ADDITION SILICONE IMPRESSION MATERIAL) | Cosmedent, Inc. | 2004-06-17 | Traditional | PDF ↗ |
| K041028 | CROWN DELTA HYDROPHILIC IMPRESSION MATERIAL | Crown Delta Corp. | 2004-05-14 | Traditional | PDF ↗ |
| K040053 | PRECISION VPS IMPRESSION MATERIAL | Discus Dental, Inc. | 2004-03-25 | Traditional | PDF ↗ |
| K032708 | PLASTALGIN AND PLASTALGIN ORTHO | Septodont | 2003-11-20 | Traditional | PDF ↗ |
| K032289 | FIT CHECKER II | GC America, Inc. | 2003-10-20 | Traditional | PDF ↗ |
| K031439 | ALGINATE IMPRESSION MATERIAL III (FAST & REGULAR) | Harry J. Bosworth Co. | 2003-10-02 | Traditional | PDF ↗ |
| K032116 | TULIP COLORSWITCH | Cavex Holland BV | 2003-09-30 | Traditional | PDF ↗ |
| K032001 | POLY Q (GARANT L, PENTA M, PENTA H) | 3M Espe AG Dental Products | 2003-08-11 | Traditional | PDF ↗ |
| K031484 | STAND OUT | Kerr Corp. | 2003-07-03 | Traditional | PDF ↗ |
| K030776 | MEGA BITE REGISTRATION - DENTAL BITE REGISTRATION MATERIAL | Discus Dental, Inc. | 2003-05-09 | Traditional | PDF ↗ |
| K030414 | GENIE ULTRA HYDROPHILIC IMPRESSION MATERIAL | Sultan Chemists, Inc. | 2003-04-09 | Traditional | PDF ↗ |
| K030318 | P2 POLYETHER | Heraeus Kulzer, Inc. | 2003-04-03 | Traditional | PDF ↗ |
| K023751 | EXAJET | GC America, Inc. | 2003-01-22 | Traditional | PDF ↗ |
| K024041 | ZETAPLUS SOFT | Zhermack S.P.A. | 2002-12-18 | Special | PDF ↗ |
| K024034 | OCCLUFAST ROCK | Zhermack S.P.A. | 2002-12-18 | Special | PDF ↗ |
| K023466 | TULIP ALGINATE IMPRESSION MATERIAL | Cavex Holland BV | 2002-12-13 | Traditional | PDF ↗ |
| K022653 | ELITE MONOPHASE | Zhermack S.P.A. | 2002-10-28 | Traditional | PDF ↗ |
| K022430 | ISO FUNCTIONAL | GC America, Inc. | 2002-10-18 | Traditional | PDF ↗ |
| K022066 | REGISTRADO X-TRA | Voco GmbH | 2002-08-14 | Traditional | PDF ↗ |
| K021416 | AQUASIL ULTRA MONOPHASE/HEAVY/LV SMART WETTING IMPRESSION MATERIAL | Dentsply Intl. | 2002-05-13 | Special | PDF ↗ |
| K021413 | AQUASIL ULTRA RIGID SMART WETTING IMPRESSION MATERIAL | Dentsply Intl. | 2002-05-10 | Special | PDF ↗ |
| K021410 | AQUASIL ULTRA XLV SMART WETTING IMPRESSION MATERIAL | Dentsply Intl. | 2002-05-08 | Special | PDF ↗ |
| K020242 | EMULATE FAST SET AND EMULATE REGULAR SET | Cavex Holland BV | 2002-04-17 | Traditional | PDF ↗ |
| K013859 | RHODIA BITE REGISTRATION MATERIAL | Rhodia, Inc. | 2002-01-29 | Traditional | PDF ↗ |
| K012517 | CEREC3 VITABLOCKS | Sirona Dental Systems GmbH | 2001-11-01 | Traditional | PDF ↗ |
| K012767 | S & C HYDRO VINYL POLYSILOXANE IMPRESSION MATERIAL | S & C Polymer GmbH | 2001-11-01 | Traditional | PDF ↗ |
| K013336 | XANTALGIN CRONO | Cavex Holland BV | 2001-10-29 | Traditional | PDF ↗ |
| K013237 | STATUSBLUE | Dmg USA, Inc. | 2001-10-22 | Abbreviated | PDF ↗ |
| K013236 | LUXABITE | Dmg USA, Inc. | 2001-10-17 | Abbreviated | PDF ↗ |
| K013129 | RHODIA DENTAL PUTTY IMPRESSION MATERIAL | Rhodia, Inc. | 2001-10-10 | Traditional | PDF ↗ |
| K013140 | RHODIA HYDROPHILIC DENTAL IMPRESSION MATERIAL | Rhodia, Inc. | 2001-10-10 | Traditional | PDF ↗ |
| K012405 | EXTRUDE MODIFIED | Sybron Dental Specialties, Inc. | 2001-09-04 | Traditional | PDF ↗ |
| K011785 | NOVEL PRINT CYAN ALGINATES | Manufacturera Dental Continental | 2001-09-04 | Traditional | PDF ↗ |
| K011452 | CAVEX STABISIL | Cavex Holland BV | 2001-07-19 | Traditional | PDF ↗ |
| K011419 | CAVEX COLORCHANGE | Cavex Holland BV | 2001-07-16 | Traditional | PDF ↗ |
| K011450 | SILICONE IMPRESSION MATERIAL | Northeast Resins & Silicones, LLC | 2001-06-13 | Traditional | PDF ↗ |
| K010994 | TAKE ONE BITE MODIFIED | Kerr Corp. | 2001-04-23 | Traditional | PDF ↗ |
| K010926 | R-SI-LINE METAL-BITE | R-Dental Dentalerzeugnisse GmbH | 2001-04-12 | Traditional | PDF ↗ |
| K003808 | TAKE 1 | Sybron Dental Specialties, Inc. | 2001-03-01 | Traditional | PDF ↗ |
| K003650 | PERMLASTIC 3 | Sybron Dental Specialties, Inc. | 2001-02-15 | Traditional | PDF ↗ |
| K003930 | FLEXTIME MAGNUM 360 | Heraeus Kulzer, Inc. | 2001-02-01 | Traditional | PDF ↗ |
| K003426 | ALGINATE IMPRESSION MATERIAL | Rite-Dent Manufacturing Corp. | 2001-01-23 | Traditional | PDF ↗ |
| K001655 | PERMLASTIC 2 | Kerr Corp. | 2000-08-10 | Traditional | PDF ↗ |
| K001414 | KWIKKMODEL | R-Dental Dentalerzeugnisse GmbH | 2000-08-09 | Traditional | PDF ↗ |
| K001876 | TAKE 1 BITE | Sybron Dental Specialties, Inc. | 2000-07-21 | Traditional | PDF ↗ |
| K001218 | CORRECT PLUS | Jeneric/Pentron, Inc. | 2000-07-05 | Traditional | PDF ↗ |
| K000686 | KROM-ALGINATE AND ALGINATE PLUS | Cavex Holland BV | 2000-05-25 | Traditional | PDF ↗ |
| K994027 | ACTIVATOR PASTE | Harry J. Bosworth Co. | 2000-04-13 | Traditional | PDF ↗ |
| K000878 | HONIGUM | Dmg USA, Inc. | 2000-04-11 | Abbreviated | PDF ↗ |
| K000595 | DIMENSION PENTA L | Espe Dental AG | 2000-04-05 | Traditional | PDF ↗ |
| K000629 | FLEXTIME | Heraeus Kulzer, Inc. | 2000-04-05 | Traditional | PDF ↗ |
| K000588 | DIMENSION GARANT L, DIMENSION GARANT L QUICK | Espe Dental AG | 2000-03-30 | Traditional | PDF ↗ |
| K000591 | DIMENSION PENTA H, DIMENSION PENTA H QUICK | Espe Dental AG | 2000-03-30 | Traditional | PDF ↗ |
| K994172 | CEREC 3 | Sirona Dental Systems GmbH | 2000-02-08 | Special | PDF ↗ |
| K994193 | IMPREGUM PENTA DUOSOFT | Espe Dental AG | 2000-01-28 | Traditional | PDF ↗ |
| K994192 | IMPREGUM PENTA M MONOSOFT | Espe Dental AG | 2000-01-28 | Traditional | PDF ↗ |
| K994077 | AROMA FINE (NORMAL AND FAST SET) | GC America, Inc. | 2000-01-27 | Traditional | PDF ↗ |
| K994190 | IMPREGUM GARANT L DUOSOFT | Espe Dental AG | 2000-01-27 | Traditional | PDF ↗ |
| K992001 | TRAY-LINK | Silicon-Und Composite Spezialitaten GmbH | 1999-11-02 | Traditional | PDF ↗ |
| K992895 | IMPREGUM F | Espe Dental AG | 1999-09-08 | Special | PDF ↗ |
| K992897 | IMPREGUM PENTA | Espe Dental AG | 1999-09-08 | Special | PDF ↗ |
Product code ELW · Class II · Dental. Data: openFDA.