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 4 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K953592 | REVOLUTION BOND | E&D Dental Products, Inc. | 1995-09-07 | Traditional | PDF ↗ |
| K953859 | BOND-IT DUAL CURE ACTIVATOR | Jeneric/Pentron, Inc. | 1995-09-07 | Traditional | PDF ↗ |
| K953527 | PERMUALUTE INDIRECT RESTORATIVE BONDING PRIMERS | Ultradent Products, Inc. | 1995-08-29 | Traditional | PDF ↗ |
| K952124 | ABOND | Parkell, Inc. | 1995-06-20 | Traditional | PDF ↗ |
| K952123 | MS EMULSION | Parkell, Inc. | 1995-06-20 | Traditional | PDF ↗ |
| K951864 | PRIME & BOND DIRECT COMPOSITE BONDING AGENT | Dentsply Intl. | 1995-05-23 | Traditional | PDF ↗ |
| K951867 | PERMAQUIK BONDING PRIMER | Ultradent Products, Inc. | 1995-05-23 | Traditional | PDF ↗ |
| K951583 | PERMAQUIK BONDING PRIMER | Ultradent Products, Inc. | 1995-05-12 | Traditional | PDF ↗ |
| K951220 | HEMA-GLU | Health-Dent Intl., Inc. | 1995-05-12 | Traditional | PDF ↗ |
| K950905 | C&B-METABOND RADIOPAQUE POWDER | Parkell, Inc. | 1995-04-10 | Traditional | PDF ↗ |
| K950860 | PERMALUTE | Ultradent Products, Inc. | 1995-03-23 | Traditional | PDF ↗ |
| K945604 | ECLIPTOMER | Bisco, Inc. | 1995-01-03 | Traditional | PDF ↗ |
| K945112 | PULPDENT DUAL CURE UNFILLED BONDING RESIN | Pulpdent Corp. | 1994-12-14 | Traditional | PDF ↗ |
| K933360 | GLUMA 3 STEP BONDING SYSTEM/ GLUMA 3 PRIMER/DESENSITIZER | Miles Inc., Dental Products | 1994-11-22 | Traditional | PDF ↗ |
| K943738 | OPTIBOND-D | Sybron Dental Specialties, Inc. | 1994-09-09 | Traditional | PDF ↗ |
| K943373 | PERMAGEN F/DC | Ultradent Products, Inc. | 1994-08-23 | Traditional | PDF ↗ |
| K943170 | CLEARFIL LINER BOND 2 | Kuraray Company, Ltd. | 1994-08-10 | Traditional | PDF ↗ |
| K943167 | CLEARFIL NEW BOND | Kuraray Company, Ltd. | 1994-08-10 | Traditional | PDF ↗ |
| K943165 | CLEARFIL PHOTO BOND | Kuraray Company, Ltd. | 1994-08-10 | Traditional | PDF ↗ |
| K943166 | CLEARFIL LINER BOND SYSTEM | Kuraray Company, Ltd. | 1994-08-10 | Traditional | PDF ↗ |
| K942017 | V-PRIMER | Parkell, Inc. | 1994-07-06 | Traditional | PDF ↗ |
| K942493 | SCOTCHBOND MULTI-PURPOSE PLUS DENTAL ADHESIVE SYSTEM | 3M Company | 1994-07-05 | Traditional | PDF ↗ |
| K941572 | FLUORIDE-PSA PRIME/ADHESIVE | Dentsply Intl. | 1994-06-10 | Traditional | PDF ↗ |
| K940513 | OPTIBOND | Kerr Corporation (Danbury) | 1994-04-15 | Traditional | PDF ↗ |
| K936222 | DENTIN CONDITIONING AND ADHESIVE SYSTEM | Jeneric/Pentron, Inc. | 1994-03-15 | Traditional | PDF ↗ |
| K935961 | GC FUJI COAT LC | GC America, Inc. | 1994-03-10 | Traditional | PDF ↗ |
| K935735 | ATTACHMENT BOND | Heraeus Kulzer, Inc. | 1994-03-07 | Traditional | PDF ↗ |
| K936100 | CLEARFIL LINER BOND 2 | Kuraray Intl. Corp. | 1994-02-03 | Traditional | PDF ↗ |
| K934596 | BISCO DUO LINK D/C LUTING COMPOSITE | Bisco, Inc. | 1994-01-26 | Traditional | PDF ↗ |
| K934690 | KERR OPTIBOND, MODIFICATION | Kerr Corporation (Danbury) | 1993-12-30 | Traditional | PDF ↗ |
| K931710 | PULPDENT DENTAL BOND ENHANCER 2-B | Pulpdent Corp. | 1993-08-24 | Traditional | PDF ↗ |
| K931870 | BONDING RESIN PRODUCT LINE | Ultradent Products, Inc. | 1993-07-22 | Traditional | PDF ↗ |
| K932379 | ALL-BOND(R) JR. | Bisco, Inc. | 1993-07-22 | Traditional | PDF ↗ |
| K931838 | DENTHESIVE II | Heraeus Kulzer, Inc. | 1993-07-08 | Traditional | PDF ↗ |
| K931812 | NEW DENTINE ADHESIVE | Dentsply Intl. | 1993-07-08 | Traditional | PDF ↗ |
| K930504 | NEW DENTIN PRIMER | Dentsply Intl. | 1993-05-27 | Traditional | PDF ↗ |
| K930989 | PULPDENT UNFILLED DUAL CURE BONDING RESIN | Pulpdent Corp. | 1993-04-20 | Traditional | PDF ↗ |
| K924378 | RESTOBOND 4 | Lee Pharmaceuticals | 1993-03-31 | Traditional | PDF ↗ |
| K913581 | WILDE ADHESIVE BONDING SYSTEM | Wilde-USA, Inc. | 1993-02-26 | Traditional | PDF ↗ |
| K925404 | CLEARFIL PORCELAIN BOND ACTIVATOR | Kuraray Co. | 1993-01-11 | Traditional | PDF ↗ |
| K924670 | DENTIN RELIEF | Professional Technologies Corp. | 1992-11-23 | Traditional | PDF ↗ |
| K924181 | POLIBOND | Voco GmbH | 1992-10-16 | Traditional | PDF ↗ |
| K923842 | BISCO UNIVERSAL BOND-3 | Bisco, Inc. | 1992-09-29 | Traditional | PDF ↗ |
| K923546 | OPTIBOND | Kerr Corporation (Danbury) | 1992-09-29 | Traditional | PDF ↗ |
| K922615 | COLTENE A.R.T. BOND | Coltene/Whaledent, Inc. | 1992-08-03 | Traditional | PDF ↗ |
| K921701 | DURAFILL BOND | Heraeus Kulzer, Inc. | 1992-06-09 | Traditional | PDF ↗ |
| K920424 | SCOTCHBOND BRAND MULTI-PURPOSE ADHESIVE SYSTEM | 3M Company | 1992-03-20 | Traditional | PDF ↗ |
| K915511 | MIRAGE COMPLETE KIT AND MIRAGE ABC KIT | Mirage Dental Systems | 1992-03-06 | Traditional | PDF ↗ |
| K910069 | SR-ISOSIT SPECTRA LINK SYSTEM | Ivoclar North America, Inc. | 1992-03-02 | Traditional | PDF ↗ |
| K915830 | PRISMA UNIVERSAL BOND(R) 3 | Dentsply Intl. | 1992-03-02 | Traditional | PDF ↗ |
| K913965 | ESPE(R) -SIL | Espe GmbH (Us) | 1991-12-04 | Traditional | PDF ↗ |
| K913946 | IMPERVA DUAL | Shofu Dental Corp. | 1991-12-03 | Traditional | PDF ↗ |
| K911282 | PULPDENT ENAMEL BONDING AGENT | Pulpdent Corp. | 1991-09-06 | Traditional | PDF ↗ |
| K912707 | CLEARFIL LINER BOND SYSTEM | Kuraray Co. | 1991-08-20 | Traditional | PDF ↗ |
| K912256 | PRECISE(R) BETA QUARTZ GLASS-CERAMIC INSERT | Lee Pharmaceuticals | 1991-07-24 | Traditional | PDF ↗ |
| K911525 | TOKUSO LIGHT BOND | Tokuyama America, Inc. | 1991-05-15 | Traditional | PDF ↗ |
| K910860 | ALL-BOND 2 | Bisco, Inc. | 1991-04-29 | Traditional | PDF ↗ |
| K910628 | ALL BOND LINER-F | Bisco, Inc. | 1991-03-29 | Traditional | PDF ↗ |
| K905302 | DENTHESIVE | Kulzer, Inc. | 1991-02-26 | Traditional | PDF ↗ |
| K904724 | CONQUEST DIRECT FILLING COMPOSITE (DFC) | Jeneric/Pentron, Inc. | 1990-12-07 | Traditional | PDF ↗ |
| K904289 | PERTAC UNIVERSAL BOND | Espe GmbH (Us) | 1990-11-01 | Traditional | PDF ↗ |
| K902744 | DEGUFILL (TM) BOND | Degussa AG | 1990-08-15 | Traditional | PDF ↗ |
| K901871 | DEGUFILL (R) ADHESIVE | Degussa AG | 1990-08-06 | Traditional | PDF ↗ |
| K901870 | DEGUFILL (R) BOND | Degussa AG | 1990-08-06 | Traditional | PDF ↗ |
| K901913 | SYNTAC (DENTIN BONDING AGENT) | Ivoclar North America, Inc. | 1990-06-26 | Traditional | PDF ↗ |
| K897009 | PALFIQUE LIGHT BONDING AGENT | Tokuyama America, Inc. | 1990-05-15 | Traditional | PDF ↗ |
| K900558 | PERTAC BOND | Espe GmbH (Us) | 1990-04-10 | Traditional | PDF ↗ |
| K897020 | ALL-BOND DENTIN BONDING SYSTEM | Bisco, Inc. | 1990-03-14 | Traditional | PDF ↗ |
| K896655 | 9.6% HYDROFLUORIC ACID GEL | Pulpdent Corp. | 1990-02-14 | Traditional | PDF ↗ |
| K896659 | SILANE | Pulpdent Corp. | 1990-02-14 | Traditional | PDF ↗ |
| K896382 | MODIFIED GLUMA BONDING SYSTEM | Heraeus Kulzer, Inc. | 1990-02-01 | Traditional | PDF ↗ |
| K895750 | HEMA-PRIMER | Parkell | 1989-12-21 | Traditional | PDF ↗ |
| K894315 | RESTOBOND 3/DENTIN-ENAMEL BONDING AGENT | Lee Pharmaceuticals | 1989-10-31 | Traditional | PDF ↗ |
| K894994 | DENTIN BONDING SYSTEM | Cosmedent, Inc. | 1989-10-24 | Traditional | PDF ↗ |
| K894391 | PVS DUAL CURE VENEER BONDING KIT | Jelenko Co. | 1989-09-19 | Traditional | PDF ↗ |
| K892003 | ABRAKADABRA - DENTAL ADHESIVE SYSTEM | Parkell | 1989-06-07 | Traditional | PDF ↗ |
| K891455 | DENTIN PRIMER | Dentsply Intl. | 1989-05-18 | Traditional | PDF ↗ |
| K884533 | SENSODYNE SEALANT DENTIN CONDITIONING SYSTEM | Block Drug Company, Inc. | 1989-04-12 | Traditional | PDF ↗ |
| K884918 | PORCELAIN ETCHING GEL AND ETCHING GEL BARRIER | Parkell | 1989-02-13 | Traditional | PDF ↗ |
| K885010 | TRIPTON(TM) VISIBLE LIGHT-CURED UNIV. BONDING | Coe Laboratories, Inc. | 1989-02-13 | Traditional | PDF ↗ |
| K884752 | KETAC-GLAZE | Espe GmbH (Us) | 1989-01-19 | Traditional | PDF ↗ |
| K884137 | MIRAGE BOND | Chameleon Dental Products, Inc. | 1988-12-07 | Traditional | PDF ↗ |
| K880684 | XR PRIMER | Kerr Corporation (Danbury) | 1988-05-11 | Traditional | PDF ↗ |
| K874074 | TEMPORARY DISCLOSING SOLUTION | Dentsply Intl. | 1987-12-29 | Traditional | PDF ↗ |
| K872959 | CLEARFIL PHOTO BOND | Kuraray Co. | 1987-11-20 | Traditional | PDF ↗ |
| K871636 | CLEARFIL PORCELAIN BOND | Kuraray Co. | 1987-07-02 | Traditional | PDF ↗ |
| K862829 | PANAGRAF | Panadent International, Inc. | 1986-09-19 | Traditional | PDF ↗ |
| K863522 | MODIFIED SELF-CURE BONDING AGENT | Dentsply Intl. | 1986-09-19 | Traditional | PDF ↗ |
| K860971 | DEN-MAT GOLD LINK (FORMERLY DEN-MAT METAL OPAQUER) | Den-Mat Corp. | 1986-03-25 | Traditional | PDF ↗ |
| K860346 | KERR PORCELITE | Kerr Corporation (Danbury) | 1986-03-25 | Traditional | PDF ↗ |
| K852660 | ETCH AND BOND | Dentsply Intl. | 1985-07-25 | Traditional | PDF ↗ |
| K851056 | OPAQUER/BONDING AGENT | Dentsply Intl. | 1985-04-22 | Traditional | PDF ↗ |
| K843025 | COMMAND ENAMEL-DENT DENTAL ADHESIVE | Kerr Corporation (Danbury) | 1984-10-25 | Traditional | PDF ↗ |
| K843023 | KERR PORCELAIN REPAIR PRIMER | Kerr Corporation (Danbury) | 1984-10-25 | Traditional | PDF ↗ |
| K842078 | JOHNSON & JOHNSON FLAVORED ETCHING GEL | Johnson & Johnson Professionals, Inc. | 1984-07-12 | Traditional | PDF ↗ |
| K840726 | RESTODENT DENTIN BONDING AGENT | Lee Pharmaceuticals | 1984-06-27 | Traditional | PDF ↗ |
| K841458 | NUMBER 20 R/L SYSTEM | Pentron Corp. | 1984-05-22 | Traditional | PDF ↗ |
| K841457 | NUMBER 21 R/R SYSTEM | Pentron Corp. | 1984-05-22 | Traditional | PDF ↗ |
| K833718 | ETCHING GEL | Johnson & Johnson Professionals, Inc. | 1983-12-29 | Traditional | PDF ↗ |
| K833473 | DENTIN BONDING AGENT | Johnson & Johnson Professionals, Inc. | 1983-12-27 | Traditional | PDF ↗ |
Product code KLE · Class II · Dental. Data: openFDA.