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 3 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K020050 | ENAMEL BONDING SYSTEM | Rite-Dent Manufacturing Corp. | 2002-02-14 | Traditional | PDF ↗ |
| K013542 | DENTIN CONDITIONING AND ADHESIVE SYSTEM (BOND-1) | Jeneric/Pentron, Inc. | 2002-02-14 | Traditional | PDF ↗ |
| K013584 | EXCITE SELF ETCH | Ivoclar Vivadent, Inc. | 2002-01-28 | Traditional | PDF ↗ |
| K013519 | SIMPLE | Bisco, Inc. | 2002-01-17 | Traditional | PDF ↗ |
| K012082 | OPTIBOND SOLO PLUS ACTIVATOR | Sybron Dental Specialties, Inc. | 2001-09-20 | Traditional | PDF ↗ |
| K012734 | CLEARFIL NEW BOND | Kuraray Medical, Inc. | 2001-09-14 | Traditional | PDF ↗ |
| K012730 | CLEARFIL PORCELAIN BOND ACTIVATOR | Kuraray Medical, Inc. | 2001-09-13 | Traditional | PDF ↗ |
| K012729 | CLEARFIL REPAIR | Kuraray Medical, Inc. | 2001-09-13 | Traditional | PDF ↗ |
| K012442 | MODIFICATION TO CLEARFIL SE BOND | Kuraray Medical, Inc. | 2001-09-10 | Traditional | PDF ↗ |
| K012440 | MODIFICATION TO CLEARFIL LINER BOND 2V | Kuraray Medical, Inc. | 2001-09-05 | Traditional | PDF ↗ |
| K012436 | MODIFICATION TO ALLOY PRIMER | Kuraray Medical, Inc. | 2001-09-04 | Traditional | PDF ↗ |
| K012432 | MODIFICATION TO CLEARFIL PHOTO BOND | Kuraray Medical, Inc. | 2001-09-04 | Traditional | PDF ↗ |
| K012322 | OPTIBOND 2 | Sybron Dental Specialties, Inc. | 2001-08-30 | Traditional | PDF ↗ |
| K010547 | VERTEX SEALAND L/C ORTHODONTIC SEALANT | Apex Dental Materials, Inc. | 2001-08-16 | Traditional | PDF ↗ |
| K010415 | ISODAN | Specialites Septodont | 2001-07-23 | Traditional | PDF ↗ |
| K011490 | MODIFICATION TO EXCITE | Ivoclar North America, Inc. | 2001-06-27 | Traditional | PDF ↗ |
| K011167 | XSE | 3M Company | 2001-05-17 | Traditional | PDF ↗ |
| K003293 | EXCITE DSC | Ivoclar North America, Inc. | 2001-02-06 | Traditional | PDF ↗ |
| K003011 | SELF ETCH BONDING PRIMER | Jeneric/Pentron, Inc. | 2000-11-28 | Traditional | PDF ↗ |
| K003153 | SOLOBOND PLUS | Voco GmbH | 2000-11-15 | Traditional | PDF ↗ |
| K002502 | CERAM-PRIME | S & C Polymer GmbH | 2000-11-08 | Traditional | PDF ↗ |
| K001914 | CLEARFIL REPAIR | Kuraray Company, Ltd. | 2000-08-10 | Traditional | PDF ↗ |
| K001494 | MODIFICATION TO PROMPT L-POP | Espe Dental AG | 2000-07-07 | Traditional | PDF ↗ |
| K000189 | PQ1 | Ultradent Products, Inc. | 2000-05-11 | Traditional | PDF ↗ |
| K000954 | KERR GEL ETCHANT | Sybron Dental Specialties, Inc. | 2000-04-28 | Traditional | PDF ↗ |
| K994359 | BOND 1 C & B | Jeneric/Pentron, Inc. | 2000-03-21 | Traditional | PDF ↗ |
| K994302 | RESIN TOOTH BONDING AGENT | Parkell, Inc. | 2000-02-07 | Traditional | PDF ↗ |
| K993917 | TOKUYAMA ONE-UP-BOND F | Tokuyama America, Inc. | 2000-02-02 | Traditional | PDF ↗ |
| K993683 | PULPDENT UNO-DUO | Pulpdent Corp. | 1999-12-13 | Traditional | PDF ↗ |
| K993013 | SURE BOND | Miradent Distributing Co., LLC | 1999-11-29 | Traditional | PDF ↗ |
| K992838 | ADHERE CONDITIONER, ADHERE PRIMER, ADHERE LC ADHESIVE, ADHERE DC ADHERE DC ACTIVATOR, ADHERE CYLANATE | Biomat Sciences, Inc. | 1999-11-15 | Traditional | PDF ↗ |
| K992879 | ECUSIT COMPOSITE REPAIR | Dmg Hamburg | 1999-11-09 | Traditional | PDF ↗ |
| K992985 | GLUMA COMFORT BOND | Heraeus Kulzer, Inc. | 1999-10-14 | Traditional | PDF ↗ |
| K992292 | GLUMA COMFORT BOND + DESENSITIZER | Heraeus Kulzer, Inc. | 1999-10-01 | Traditional | PDF ↗ |
| K992048 | MODIFICATION OF PROMPT L-POP | Espe Dental AG | 1999-08-16 | Traditional | PDF ↗ |
| K991808 | OPTIBOND SOLO PLUS 2 | Sybron Dental Specialties, Inc. | 1999-07-09 | Traditional | PDF ↗ |
| K990534 | EXCITE | Ivoclar North America, Inc. | 1999-03-19 | Traditional | PDF ↗ |
| K990498 | OPTIBOND SOLO PLUS | Sybron Dental Specialties, Inc. | 1999-03-08 | Traditional | PDF ↗ |
| K984503 | ALPHA BOND DENTIN/ENAMEL BONDING AGENT, MODEL 213-000 | Wallace A. Erickson & Co. | 1999-02-26 | Traditional | PDF ↗ |
| K990143 | GLUMA ONE BOND | Heraeus Kulzer, Inc. | 1999-02-25 | Traditional | PDF ↗ |
| K990040 | CLEARFIL SE BOND | Kuraray Co. | 1999-02-04 | Traditional | PDF ↗ |
| K984246 | PROMPT L-POP | Espe Dental AG | 1999-01-08 | Traditional | PDF ↗ |
| K983414 | EVERBOND | Espe Dental AG | 1998-12-16 | Traditional | PDF ↗ |
| K983668 | MODIFICATION OF PQ1 | Ultradent Products, Inc. | 1998-11-30 | Traditional | PDF ↗ |
| K983545 | QUADRANT UNIBOND | Cavex Holland BV | 1998-11-18 | Traditional | PDF ↗ |
| K982394 | PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM | Dentsply Intl. | 1998-09-21 | Traditional | PDF ↗ |
| K982007 | TRUBYTE DENTURE BOND DENTURE BONDING AGENT | Dentsply Intl. | 1998-07-22 | Traditional | PDF ↗ |
| K981514 | GC FUJI BOND LC | GC America, Inc. | 1998-06-16 | Traditional | PDF ↗ |
| K981383 | ALLOYBOND | Southern Dental Industries, Inc. | 1998-06-16 | Traditional | PDF ↗ |
| K974906 | ONE COAT BOND DENTIN/ENAMEL ADHESIVE SYSTEM | Coltene/Whaledent, Inc. | 1998-03-24 | Traditional | PDF ↗ |
| K980539 | SOLOBOND M | Voco GmbH | 1998-03-23 | Traditional | PDF ↗ |
| K973002 | HURRISEAL DENTIN DESENSITIZER | Cheng & Assoc., Inc. | 1998-03-23 | Traditional | PDF ↗ |
| K974786 | PREPQUICK | Ultradent Products, Inc. | 1998-03-03 | Traditional | PDF ↗ |
| K973285 | D/SENSE-T | Centrix, Inc. | 1998-02-25 | Traditional | PDF ↗ |
| K974390 | GLUMA ONE BOND | Heraeus Kulzer, Inc. | 1998-02-04 | Traditional | PDF ↗ |
| K974283 | PQ 1 | Ultradent Products, Inc. | 1998-01-29 | Traditional | PDF ↗ |
| K974486 | CLEARFIL LINER BOND 2V | Kuraray America, Inc. | 1998-01-29 | Traditional | PDF ↗ |
| K974089 | ALLOY PRIMER | Kuraray America, Inc. | 1997-12-17 | Traditional | PDF ↗ |
| K973092 | STAE | Southern Dental Industries, Inc. | 1997-12-08 | Traditional | PDF ↗ |
| K973185 | AMERICAN DENTAL PRODUCTS HB-35 DESENSITIZER WITH FLUORIDE | American Dental Products, Inc. | 1997-11-14 | Traditional | PDF ↗ |
| K973245 | TOKUSO REBASE MR. BOND | Tokuyama America, Inc. | 1997-10-07 | Traditional | PDF ↗ |
| K971733 | 2 BOND 2 | Heraeus Kulzer, Inc. | 1997-10-02 | Traditional | PDF ↗ |
| K972101 | SOLITAIRE | Heraeus Kulzer, Inc. | 1997-09-29 | Traditional | PDF ↗ |
| K972858 | KERR NEXUS ONE BOTTLE ADHESIVE | Sybron Dental Specialties, Inc. | 1997-09-26 | Traditional | PDF ↗ |
| K973388 | DENTIN CONDITIONING AND ADHESIVE (BOND 1) | Jeneric/Pentron, Inc. | 1997-09-12 | Traditional | PDF ↗ |
| K972421 | EASY BOND | Parkell, Inc. | 1997-08-29 | Traditional | PDF ↗ |
| K972594 | METALPRIMER II | GC America, Inc. | 1997-08-26 | Traditional | PDF ↗ |
| K971121 | ENCORE BOND | Centrix, Inc. | 1997-06-27 | Traditional | PDF ↗ |
| K970848 | SILOC SYSTEM | Heraeus Kulzer, Inc. | 1997-05-06 | Traditional | PDF ↗ |
| K964867 | HYBRID RESIN COMPOSITE | Parkell, Inc. | 1997-04-11 | Traditional | PDF ↗ |
| K964038 | CHARISMA F, CHARISMA CREACTIVE, SOLID BOND, & ESTICID -20FG | Heraeus Kulzer, Inc. | 1997-04-02 | Traditional | PDF ↗ |
| K965138 | DENTINSENSE B/C | Centrix, Inc. | 1997-02-14 | Traditional | PDF ↗ |
| K964735 | DENTINSENSE | Centrix, Inc. | 1997-02-05 | Traditional | PDF ↗ |
| K964525 | PRIME & BOND 2.1 M.P. DENTIN/ENAMEL BONDING AGENT W/ACTIVATOR | Dentsply Intl. | 1997-01-22 | Traditional | PDF ↗ |
| K964133 | AMERICAN DENTAL PRODUCTS HG 35 DESENSITIZER WITH FLUORIDE | American Dental Products, Inc. | 1997-01-09 | Traditional | PDF ↗ |
| K964000 | BISFIL 2B | Bisco, Inc. | 1996-11-05 | Traditional | PDF ↗ |
| K964140 | GLUMA CONDITIONER | Heraeus Kulzer, Inc. | 1996-11-05 | Traditional | PDF ↗ |
| K962812 | GLUMA DESENSITIZER/GLUMA 3 PRIMER | Heraeus Kulzer, Inc. | 1996-10-07 | Traditional | PDF ↗ |
| K962428 | EBS (ESPE BONDING SYSTEM) | Espe GmbH & Co. Kg. | 1996-09-12 | Traditional | PDF ↗ |
| K962785 | 3M DENT SYSTEM | 3M Company | 1996-08-12 | Traditional | PDF ↗ |
| K962515 | KERR ADVANCED ADHESIVE | Kerr Dental Materials Center | 1996-08-01 | Traditional | PDF ↗ |
| K960696 | PERMALUTE COMPOSITE LUTING/RESTORATIVE RESIN SYSTEM | Ultradent Products, Inc. | 1996-07-18 | Traditional | PDF ↗ |
| K962348 | PRIME & BOND 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT | Dentsply Intl. | 1996-07-18 | Traditional | PDF ↗ |
| K962277 | SELF CURE BONDING AGENT | Dent Zar, Inc. | 1996-07-03 | Traditional | PDF ↗ |
| K961822 | WET-PREP | Bisco, Inc. | 1996-06-11 | Traditional | PDF ↗ |
| K960697 | ULTRACID AND ULTRACID F DISINFECTING SOLUTION | Ultradent Products, Inc. | 1996-05-06 | Traditional | PDF ↗ |
| K960823 | PRIME & BOND 2.0 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT | Dentsply Intl. | 1996-04-26 | Traditional | PDF ↗ |
| K960365 | ALPHA-DENT HEMA DESENTIZER(748-000)/WITH FLUORIDE(747-000) | Wallace A. Erickson & Co. | 1996-03-28 | Traditional | PDF ↗ |
| K955328 | CONFI-BOND | Confi-Dental Products Co. | 1996-03-28 | Traditional | PDF ↗ |
| K960879 | AMALGAMIBOND PLUS | Parkell, Inc. | 1996-03-22 | Traditional | PDF ↗ |
| K955740 | GLUFLORMA | Midwest Orthodontic Mfg. | 1996-02-08 | Traditional | PDF ↗ |
| K955279 | D-SENSE | Centrix, Inc. | 1995-12-28 | Traditional | PDF ↗ |
| K954708 | SILANE PRIMER | Sybron Dental Specialties, Inc. | 1995-10-30 | Traditional | PDF ↗ |
| K954133 | AMERICAN DENTAL PRODUCTS WETTING AGENT & DESENSITIZER | American Dental Products, Inc. | 1995-10-30 | Traditional | PDF ↗ |
| K953613 | IMPERVA ENSURABOND | Shofu Dental Corp. | 1995-10-04 | Traditional | PDF ↗ |
| K953612 | IMPERVA FLUOROBOND | Shofu Dental Corp. | 1995-10-04 | Traditional | PDF ↗ |
| K953504 | MICROPRIME | Danville Engineering, Inc. | 1995-10-03 | Traditional | PDF ↗ |
| K953405 | HEMA-BENZ | Health-Dent Intl., Inc. | 1995-09-27 | Traditional | PDF ↗ |
| K953166 | FUJI BOND LC | GC America, Inc. | 1995-09-27 | Traditional | PDF ↗ |
| K953476 | MULTI-PRIME AKA/MONO-PRIME | Silicon-Und Composite Spezialitaten GmbH | 1995-09-22 | Traditional | PDF ↗ |
Product code KLE · Class II · Dental. Data: openFDA.