FDA Product Code
FDA Product Code KLE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.3200
510(k) Clearances — 420 records · page 2 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K110302 | ADHESIVE EXL-759 | 3M Espe AG | 2011-05-19 | Traditional | PDF ↗ |
| K110252 | BEAUTIBOND MULTI PR PLUS | Shofu Dental Corp. | 2011-05-13 | Traditional | PDF ↗ |
| K110235 | BEAUTIBOND MULTI | Shofu Dental Corp. | 2011-05-13 | Traditional | PDF ↗ |
| K102254 | DMP SINGLE BONDING | Dmp, Ltd. | 2010-11-23 | Traditional | PDF ↗ |
| K102844 | ALL-BOUND 3 | Bisco, Inc. | 2010-10-29 | Special | PDF ↗ |
| K101485 | ALL-ETCH, ALL- ETCH WITH BAC; UNI- ETCH, UNI- ETCH WITH BAC; ETCH- 37, ETCH- 37 WITH BAC; DARK- ETCH, DARK ETCH (BLUE- E | Bisco, Inc. | 2010-08-26 | Traditional | PDF ↗ |
| K101423 | OPTIBOND XTR | Kerr Corporation | 2010-07-30 | Traditional | PDF ↗ |
| K100752 | PEAK UNIVERSAL BOND (LIGHT CURE RESIN ADHESIVE AND CHLORHEXIDINE) | Ultradent Products, Inc. | 2010-07-16 | Traditional | PDF ↗ |
| K100347 | OPTIBOND SE | Kerr Corporation | 2010-04-30 | Traditional | PDF ↗ |
| K093014 | AMERICAN DENTAL PRODUCTS SE BONDEASY | American Dental Products, Inc. | 2010-04-16 | Traditional | PDF ↗ |
| K093744 | EXCITE F AND EXCITE DSC | Ivoclar Vivadent, Inc. | 2010-03-10 | Traditional | PDF ↗ |
| K092616 | ASCENT BOND UNIVERSAL ADHESIVE SYSTEM, MODELS 006-00029, 006-00030, 006-00044, 006-00045 | CAO Group, Inc. | 2009-10-21 | Traditional | PDF ↗ |
| K091705 | PRIMER PLUS | Bisco, Inc. | 2009-08-28 | Traditional | PDF ↗ |
| K091300 | ASCENT PORCELAIN PRIMER, MODEL 006-00078, 00600079 | CAO Group, Inc. | 2009-07-23 | Traditional | PDF ↗ |
| K090941 | ADHESE ONE F | Ivoclar Vivadent, Inc. | 2009-07-17 | Traditional | PDF ↗ |
| K090826 | MONOBOND PLUS | Ivoclar Vivadent, Inc. | 2009-05-11 | Traditional | PDF ↗ |
| K090106 | PRELUDE ONE | Danville Materials, Inc. | 2009-03-31 | Traditional | PDF ↗ |
| K083652 | IBOND TOTAL ETCH | Heraeus Kulzer,GmbH | 2009-01-21 | Traditional | PDF ↗ |
| K082744 | BEAUTIBOND | Shofu Dental Corp. | 2008-12-11 | Traditional | PDF ↗ |
| K082753 | FUTURABOND M/FUTURABOND M SINGLE DOSE | Voco GmbH | 2008-11-24 | Traditional | PDF ↗ |
| K082768 | G-BOND PLUS | GC America, Inc. | 2008-10-21 | Traditional | PDF ↗ |
| K072480 | GENERATION 8 SE ADHESIVE | Pentron Clinical Technologies | 2007-11-21 | Traditional | PDF ↗ |
| K071688 | RELIANCE S.E.P. | Reliance Orthodontic Products, Inc. | 2007-09-07 | Traditional | PDF ↗ |
| K071500 | NANO-BOND II ADHESIVE SYSTEM | Pentron Clinical Technologies | 2007-08-10 | Traditional | PDF ↗ |
| K071131 | UNO | 3M Espe AG Dental Products | 2007-07-25 | Traditional | PDF ↗ |
| K071260 | HERMES BOND 3 | 3M Espe AG Dental Products | 2007-07-17 | Traditional | PDF ↗ |
| K071452 | FL BOND II | Shofu Dental Corp. | 2007-07-09 | Traditional | PDF ↗ |
| K070723 | FUTURABOND DC/SINGLE DOSE | Voco GmbH | 2007-06-07 | Traditional | PDF ↗ |
| K070956 | SEA2 SELF ETCH ADHESIVE | 3M Espe Dental Products | 2007-05-22 | Traditional | PDF ↗ |
| K070646 | ADHESE ONE | Ivoclar Vivadent, Inc. | 2007-05-11 | Traditional | PDF ↗ |
| K070413 | ASCENT UNIVERSAL ADHESIVE, MODEL 006-00028 | CAO Group, Inc. | 2007-04-26 | Traditional | PDF ↗ |
| K070215 | TOKUYAMA BOND FORCE | Tokuyama Dental Corporation | 2007-03-30 | Traditional | PDF ↗ |
| K063444 | TOTAL ETCH BONDING AGENT | Dmg USA, Inc. | 2007-03-20 | Abbreviated | PDF ↗ |
| K070538 | XP BOND DUAL CURE UNIVERSAL TOTAL ETCH ADHESIVE | Dentsply Intl. | 2007-03-14 | Special | PDF ↗ |
| K063780 | ACE BOND SE | Bisco, Inc. | 2007-01-19 | Special | PDF ↗ |
| K063558 | PEAK SE, MODEL 5135 | Ultradent Products, Inc. | 2006-12-14 | Special | PDF ↗ |
| K063557 | PEAK BOND, MODEL 5133 | Ultradent Products, Inc. | 2006-12-12 | Special | PDF ↗ |
| K063062 | HKBOND 2006 | Heraeus Kulzer, Inc. | 2006-12-01 | Traditional | PDF ↗ |
| K062713 | ADHESIVE DC ACTIVATOR | Ivoclar Vivadent, Inc. | 2006-11-02 | Traditional | PDF ↗ |
| K061998 | PREMIER SELF-ETCHING BOND ENHANCER | Premier Dental Products Co. | 2006-10-04 | Traditional | PDF ↗ |
| K062382 | CLEARFIL DC BOND | Kuraray Medical, Inc. | 2006-09-27 | Traditional | PDF ↗ |
| K061611 | BOSWORTH DENTIN RESIN | Harry J. Bosworth Co. | 2006-09-11 | Traditional | PDF ↗ |
| K060882 | EXCEL BOND DC, MODEL 28-200100 | J. Morita USA, Inc. | 2006-09-01 | Traditional | PDF ↗ |
| K061981 | SURPASS | Apex Dental Materials, Inc. | 2006-07-31 | Abbreviated | PDF ↗ |
| K061322 | PORCELAIN PRIMER | J. Morita USA, Inc. | 2006-06-02 | Traditional | PDF ↗ |
| K060684 | ADPER PROMPT, ADPER PROMPT L-POP | 3M Espe AG Dental Products | 2006-04-24 | Traditional | PDF ↗ |
| K060469 | OPTIBOND ALL-IN-ONE | Sybron Dental Specialties, Inc. | 2006-03-28 | Traditional | PDF ↗ |
| K053103 | INTERFACE | Apex Dental Materials, Inc. | 2006-02-01 | Abbreviated | PDF ↗ |
| K053392 | FUTURABOND NR SINGLE DOSE | Voco GmbH | 2005-12-15 | Special | PDF ↗ |
| K052699 | VERSA-LINK PORCELAIN BONDING SYSTEM | Sultan Chemists, Inc. | 2005-11-16 | Traditional | PDF ↗ |
| K052501 | MULTIPLE RESIN TOOTH BONDING AGENT | Cosmedent, Inc. | 2005-10-21 | Traditional | PDF ↗ |
| K052189 | REVENEER CERAMIC REPAIR SYSTEM | Schutz-Dental GmbH | 2005-10-17 | Traditional | PDF ↗ |
| K051796 | CLEARFIL TRI-S BOND SINGLE DOSE | Kuraray Medical Kurashiki Plant | 2005-08-09 | Traditional | PDF ↗ |
| K051707 | ECLIPSE BONDING AGENT | Dentsply Intl. | 2005-07-15 | Special | PDF ↗ |
| K051463 | XENO ADHESIVE WITH ACTIVATOR | Dentsply Intl. | 2005-07-12 | Traditional | PDF ↗ |
| K051050 | SEBOND PINK LIGHT 5G, SEBOND PINK DARK 5G, SEBOND SMART 5ML, SEBOND GRIP 3G, MODELS 644090, 644091, 640066, 644092 | Schutz-Dental GmbH | 2005-06-29 | Traditional | PDF ↗ |
| K051006 | IBOND NEXT GENERATION | Heraeus Kulzer,GmbH | 2005-06-07 | Traditional | PDF ↗ |
| K050647 | ALL-IN-ONE | Bisco, Inc. | 2005-04-20 | Traditional | PDF ↗ |
| K050331 | ADHESIVE 1 | Southern Dental Industries, Inc. | 2005-03-24 | Traditional | PDF ↗ |
| K043170 | BOSWORTH BOND | Harry J. Bosworth Co. | 2005-02-25 | Traditional | PDF ↗ |
| K050386 | PRIME & BOND NT DUAL CURE NANO-TECHNOLOGY UNIVERSAL DENTAL ADHESIVE SYSTEM | Dentsply International | 2005-02-23 | Special | PDF ↗ |
| K043043 | HERMES BOND 2 | 3M Espe AG Dental Products | 2005-01-10 | Traditional | PDF ↗ |
| K043562 | BC PLUS | Vericom Co., Ltd. | 2005-01-03 | Traditional | PDF ↗ |
| K042913 | CLEARFIL TRI-S BOND | Kuraray Medical, Inc. | 2004-11-26 | Traditional | PDF ↗ |
| K042806 | QUADRANT UNIT-1-BOND | Cavex Holland BV | 2004-11-24 | Traditional | PDF ↗ |
| K042614 | S&C-SELF ETCH PR-BOND | S & C Polymer GmbH | 2004-11-22 | Traditional | PDF ↗ |
| K041680 | ORAJEL ADVANCED TOOTH DESENSITIZER | Del Pharmaceuticals, Inc. | 2004-11-10 | Traditional | PDF ↗ |
| K042670 | FUTURABOND NR | Voco GmbH | 2004-11-01 | Traditional | PDF ↗ |
| K040079 | M.L. PRIMER | Shofu Dental Corp. | 2004-09-09 | Traditional | PDF ↗ |
| K041960 | COMPOSITE/COMPOMER REPAIR KIT | Dmg USA, Inc. | 2004-08-30 | Abbreviated | PDF ↗ |
| K041471 | G-BOND | GC America, Inc. | 2004-06-29 | Traditional | PDF ↗ |
| K040952 | PRELUDE | Danville Materials, Inc. | 2004-06-29 | Traditional | PDF ↗ |
| K041343 | XENO NM LIGHT CURED DENTAL ADHESIVE | Dentsply International | 2004-06-16 | Traditional | PDF ↗ |
| K040857 | MODIFICATION TO ADPER PROMPT | 3M Espe AG Dental Products | 2004-05-10 | Traditional | PDF ↗ |
| K033974 | HERMES BOND | 3M Espe AG Dental Products | 2004-02-06 | Traditional | PDF ↗ |
| K033938 | CLEARFIL PROTECT BOND | Kuraray Medical, Inc. | 2004-01-29 | Traditional | PDF ↗ |
| K033760 | ONE COAT SE BOND | Coltene/Whaledent, Inc. | 2004-01-23 | Traditional | PDF ↗ |
| K032953 | EMBRACE WETBOND RESTORATION AND PFM REPAIR KIT | Pulpdent Corporation | 2003-12-10 | Traditional | PDF ↗ |
| K032626 | PERMAQUICK SE BONDING SYSTEM | Ultradent Products, Inc. | 2003-12-03 | Traditional | PDF ↗ |
| K032179 | COMP. E | Parkell, Inc. | 2003-09-09 | Traditional | PDF ↗ |
| K031915 | PULPDENT ETCH-RITE ROYALE | Pulpdent Corporation | 2003-08-05 | Traditional | PDF ↗ |
| K031444 | OPTIBOND FL | Kerr Dental Materials Center | 2003-07-02 | Traditional | PDF ↗ |
| K030844 | FINAL VARNISH LC | Voco GmbH | 2003-06-13 | Traditional | PDF ↗ |
| K030743 | ETCHANT 40% | Confi-Dental Products Co. | 2003-05-09 | Traditional | PDF ↗ |
| K024356 | CLEARFIL SILANE KIT | Kuraray Medical, Inc. | 2003-03-26 | Traditional | PDF ↗ |
| K023842 | CLEARFIL SE BOND PLUS | Kuraray Medical, Inc. | 2003-02-11 | Traditional | PDF ↗ |
| K023776 | XENO III DENTAL ADHESIVE | Dentsply Intl. | 2003-01-23 | Traditional | PDF ↗ |
| K022973 | ADHESIVE 14 | Ab Ardent | 2002-11-22 | Traditional | PDF ↗ |
| K022612 | IBOND GLUMA INSIDE | Heraeus Kulzer, Inc. | 2002-10-28 | Traditional | PDF ↗ |
| K023042 | PQ1 | Ultradent Products, Inc. | 2002-10-28 | Traditional | PDF ↗ |
| K021427 | CLEARFIL SA PRIMER | Kuraray Medical, Inc. | 2002-06-07 | Traditional | PDF ↗ |
| K020514 | PULPDENT GLAZE II | Pulpdent Corporation | 2002-05-16 | Traditional | PDF ↗ |
| K020570 | SIMPLICITY | Apex Dental Materials, Inc. | 2002-04-24 | Traditional | PDF ↗ |
| K020499 | BOND-3 ADHESIVE | Jeneric/Pentron, Inc. | 2002-04-22 | Traditional | PDF ↗ |
| K020303 | XR PRIMER 2 | Kerr Dental Materials Center | 2002-04-19 | Traditional | PDF ↗ |
| K020946 | ADPER PROMPT | 3M Espe AG Dental Products | 2002-04-04 | Special | PDF ↗ |
| K020239 | TOUCH&BOND-PLUS | Parkell, Inc. | 2002-03-20 | Traditional | PDF ↗ |
| K014027 | OPTIBOND SOLO PLUS 4 | Kerr Dental Materials Center | 2002-02-22 | Traditional | PDF ↗ |
| K013543 | BOND-1 C & B | Jeneric/Pentron, Inc. | 2002-02-22 | Traditional | PDF ↗ |
| K013997 | UNIFIL BOND | GC America, Inc. | 2002-02-20 | Traditional | PDF ↗ |
Product code KLE · Class II · Dental. Data: openFDA.