FDA Product Code
FDA Product Code EBF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.3690
510(k) Clearances — 937 records · page 8 of 10
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K901869 | DEGUFILL (R) H | Degussa AG | 1990-08-14 | Traditional | PDF ↗ |
| K901868 | DEGUFILL (R) M | Degussa AG | 1990-08-14 | Traditional | PDF ↗ |
| K902745 | DEGUFILL (TM) | Degussa AG | 1990-08-13 | Traditional | PDF ↗ |
| K900510 | PERTAC-HYBRID | Espe GmbH (Us) | 1990-08-09 | Traditional | PDF ↗ |
| K902743 | DEGUFILL (TM) ETCHANT GEL | Degussa AG | 1990-08-01 | Traditional | PDF ↗ |
| K901872 | DEGUFILL (R) ETCHANT | Degussa AG | 1990-08-01 | Traditional | PDF ↗ |
| K901914 | HELIO PROGRESS (DENTAL COMPOSITE) | Ivoclar North America, Inc. | 1990-06-28 | Traditional | PDF ↗ |
| K901917 | DUAL CEMENT | Ivoclar North America, Inc. | 1990-06-28 | Traditional | PDF ↗ |
| K901910 | HELIO LINK (RESIN CEMENT) | Ivoclar North America, Inc. | 1990-06-26 | Traditional | PDF ↗ |
| K901918 | HELIOTINT | Ivoclar North America, Inc. | 1990-06-26 | Traditional | PDF ↗ |
| K901916 | SPECIAL BOND | Ivoclar North America, Inc. | 1990-06-22 | Traditional | PDF ↗ |
| K901697 | SILISTOR CERAMIC AND RESIN REPAIR SYSTEM | Kulzer, Inc. | 1990-06-15 | Traditional | PDF ↗ |
| K896469 | EOS INLAY MATERIAL | Ivoclar North America, Inc. | 1990-05-25 | Traditional | PDF ↗ |
| K897011 | PALFIQUE LIGHT-S COMPOSITE RESIN | Tokuyama America, Inc. | 1990-05-15 | Traditional | PDF ↗ |
| K896769 | INTERFACE BONDING SYSTEM | Smile Horizons, Inc. | 1990-05-15 | Traditional | PDF ↗ |
| K897010 | PALFIQUE LIGHT COMPOSITE RESIN | Tokuyama America, Inc. | 1990-05-15 | Traditional | PDF ↗ |
| K901396 | CONCEPT INLAY/ONLAY | Ivoclar North America, Inc. | 1990-05-15 | Traditional | PDF ↗ |
| K896530 | FERMIT TEMPORARY MATERIAL | Ivoclar North America, Inc. | 1990-05-07 | Traditional | PDF ↗ |
| K901051 | 22% POLYACRYLIC ACID GEL | Pulpdent Corp. | 1990-04-30 | Traditional | PDF ↗ |
| K900690 | CLEARFIL VENEER BOND KIT | Kuraray Co. | 1990-04-13 | Traditional | PDF ↗ |
| K896950 | CORE BUILD UP COMPOSITE | Confi-Dental Products Co. | 1990-03-13 | Traditional | PDF ↗ |
| K896662 | AIR BLOCK | Pulpdent Corp. | 1990-02-14 | Traditional | PDF ↗ |
| K896654 | DRYING AGENT | Pulpdent Corp. | 1990-02-14 | Traditional | PDF ↗ |
| K896653 | SEPARATING MEDIUM (POLYVINYL ALCOHOL) | Pulpdent Corp. | 1990-02-14 | Traditional | PDF ↗ |
| K896658 | DENTIN DISCLOSING GEL AND GEL REMOVER | Pulpdent Corp. | 1990-02-14 | Traditional | PDF ↗ |
| K896564 | DENTAL CORE MATERIAL | Dentsply Intl. | 1990-02-09 | Traditional | PDF ↗ |
| K896132 | ENAMEL PREP ENAMEL ETCHANT (EMAIL-PREPARATOR GS) | Ivoclar North America, Inc. | 1990-01-10 | Traditional | PDF ↗ |
| K895976 | TOOTH SHADE RESIN | G-C Intl. Corp. | 1989-12-22 | Traditional | PDF ↗ |
| K895401 | NORTHERNLIGHTS ORTHODONTIC BONDING SYSTEM | Rocky Mountain Orthodontics, Inc. | 1989-12-04 | Traditional | PDF ↗ |
| K894890 | CRYSTALLINE C2 AND CRYSTALLINE L3 | Confi-Dental Products Co. | 1989-10-27 | Traditional | PDF ↗ |
| K894644 | CROWN AND BRIDGE DENTAL RESTORATIVE COMPOSITE SYST | Jeneric/Pentron, Inc. | 1989-10-20 | Traditional | PDF ↗ |
| K892455 | KULZER ADHESIVE CEMENT | Kulzer, Inc. | 1989-06-22 | Traditional | PDF ↗ |
| K892454 | KULZER INLAY SYSTEM | Kulzer, Inc. | 1989-06-16 | Traditional | PDF ↗ |
| K891698 | ZAROLAN, DUALAN, TITAN AND SUPERON | Dent Zar, Inc. | 1989-06-09 | Traditional | PDF ↗ |
| K891020 | ESPE TULUX-CEM | Espe GmbH (Us) | 1989-05-26 | Traditional | PDF ↗ |
| K891463 | ADHERENCE M5 MULTI-CURE COMPOSITE CEMENT SYSTEM | Confi-Dental Products Co. | 1989-05-19 | Traditional | PDF ↗ |
| K890123 | CLEARFIL CR INLAY | Kuraray Co. | 1989-03-31 | Traditional | PDF ↗ |
| K890140 | PHOSPHORIC-ACID ETCHING GEL | Centrix, Inc. | 1989-03-29 | Traditional | PDF ↗ |
| K884588 | HELIOMOLAR(R) DENTAL RESTORATIVE | Williams Dental Co., Inc. | 1989-01-27 | Traditional | PDF ↗ |
| K884350 | UNIREST COMPOSITE RESTORATIVE, SELF CURED | Scientific Pharmaceuticals, Inc. | 1989-01-03 | Traditional | PDF ↗ |
| K884391 | PREMET, METAL PRIMER | Scientific Pharmaceuticals, Inc. | 1989-01-03 | Traditional | PDF ↗ |
| K884681 | UNIREST LC PAINT-ON RESTORATIVE & VENEER CEMENT | Scientific Pharmaceuticals, Inc. | 1989-01-03 | Traditional | PDF ↗ |
| K884351 | UNIREST PL, ANTE./POST. RESTORATIVE, PASTE/LIQUID | Scientific Pharmaceuticals, Inc. | 1988-12-28 | Traditional | PDF ↗ |
| K884352 | SMILE-DENT ANTE./POST. RESTORATIVE, LIGHT-CURED | Scientific Pharmaceuticals, Inc. | 1988-12-22 | Traditional | PDF ↗ |
| K884038 | FIBERLITE, FIBERLITE HS AND FIBERSEAL | Jeneric/Pentron, Inc. | 1988-12-07 | Traditional | PDF ↗ |
| K882566 | VISIO-PERL | Espe GmbH (Us) | 1988-10-19 | Traditional | PDF ↗ |
| K883392 | LUMINBOND, BONDING AND CEMENTATION SYSTEM | Scientific Pharmaceuticals, Inc. | 1988-10-18 | Traditional | PDF ↗ |
| K882915 | FORTIFY | Bisco, Inc. | 1988-08-12 | Traditional | PDF ↗ |
| K882576 | ACID ETCH GEL | Pulpdent Corp. of America | 1988-07-15 | Traditional | PDF ↗ |
| K882400 | AMORPHUS SILK BY DENTRAX | Dale T. Dupuis | 1988-07-15 | Traditional | PDF ↗ |
| K881903 | PROSTHODENT VL | Lee Pharmaceuticals | 1988-07-01 | Traditional | PDF ↗ |
| K882006 | CLEARFIL PHOTO CORE | Kuraray Co. | 1988-06-13 | Traditional | PDF ↗ |
| K880765 | G-CERA PORCELAIN BOND | G-C Intl. Corp. | 1988-04-18 | Traditional | PDF ↗ |
| K875313 | PORCELAIN VENEER RESIN CEMENT W/DUAL CURE CATALYST | Bisco, Inc. | 1988-03-10 | Traditional | PDF ↗ |
| K872588 | CLEARFIL PHOTO POSTERIOR | Kuraray Co. | 1988-03-02 | Traditional | PDF ↗ |
| K875256 | BISCOLOR | Bisco, Inc. | 1988-02-26 | Traditional | PDF ↗ |
| K874189 | DUAL-CURE RADIOPAQUE | Pentron Corp. | 1988-02-11 | Traditional | PDF ↗ |
| K873123 | LEE COMPOSITE INLAY SYSTEM | Lee Pharmaceuticals | 1988-01-20 | Traditional | PDF ↗ |
| K874275 | OPTEC SUPPLEMENTARY KIT | Pentron Corp. | 1988-01-19 | Traditional | PDF ↗ |
| K874162 | OPTEC STAIN CHARACTERIZATION AND MODIFICATION KIT | Pentron Corp. | 1988-01-12 | Traditional | PDF ↗ |
| K873683 | CODE #23 R SYSTEM (DENTIN ADHESIVE MATERIAL) | Pentron Corp. | 1987-11-16 | Traditional | PDF ↗ |
| K873886 | CLEARFIL PORCELAIN REPAIR SYSTEM | Kuraray Co. | 1987-11-12 | Traditional | PDF ↗ |
| K873878 | #24L SYSTEM | Pentron Corp. | 1987-10-27 | Traditional | PDF ↗ |
| K872444 | SILUX PLUS LIGHT CURED RESTORATIVE MATERIAL | 3M Company | 1987-09-11 | Traditional | PDF ↗ |
| K872510 | DEN-MAT TENURE | Den-Mat Corp. | 1987-08-24 | Traditional | PDF ↗ |
| K872960 | CLEARFIL POSTERIOR NEW BOND | Kuraray Co. | 1987-08-11 | Traditional | PDF ↗ |
| K872890 | SYNERGY | Scientific Pharmaceuticals, Inc. | 1987-08-03 | Traditional | PDF ↗ |
| K872907 | DENTIN ADHESIVE | Dentsply Intl. | 1987-08-03 | Traditional | PDF ↗ |
| K871898 | IMPERVA-P | Shofu Dental Corp. | 1987-07-21 | Traditional | PDF ↗ |
| K872569 | TEMREX ETCHING GEL | Scientific Pharmaceuticals, Inc. | 1987-07-21 | Traditional | PDF ↗ |
| K871899 | IMPERVA-A | Shofu Dental Corp. | 1987-07-21 | Traditional | PDF ↗ |
| K871634 | CLEARFIL FII NEW BOND | Kuraray Co. | 1987-07-17 | Traditional | PDF ↗ |
| K871637 | CLEARFIL CORE NEW BOND | Kuraray Co. | 1987-07-17 | Traditional | PDF ↗ |
| K871635 | CLEARFIL POSTERIOR 3 | Kuraray Co. | 1987-07-16 | Traditional | PDF ↗ |
| K872243 | PEKALUX(TM) | Columbus Dental Mfg. Co. | 1987-07-07 | Traditional | PDF ↗ |
| K872272 | PEKALUX/GLUMA LIGHT CURED ANTERIOR RESTORATIVE SYS | Columbus Dental Mfg. Co. | 1987-07-02 | Traditional | PDF ↗ |
| K871164 | GLUMA(TM) BONDING SYSTEM | Columbus Dental Mfg. Co. | 1987-07-02 | Traditional | PDF ↗ |
| K872279 | SCOTCHBOND 2 ADHESIVE W/SCOTCHPREP DENTIN PRIMER | 3M Company | 1987-07-02 | Traditional | PDF ↗ |
| K871295 | ADAPTALITE* PORCELAIN VENEER CEMENTATION SYSTEM | Johnson & Johnson Professionals, Inc. | 1987-05-29 | Traditional | PDF ↗ |
| K871270 | PERFORM DENTURE BASE RESIN | Ipco Corp. | 1987-05-29 | Traditional | PDF ↗ |
| K871165 | LUMIFOR(TM) COMPOSITE | Columbus Dental Mfg. Co. | 1987-04-03 | Traditional | PDF ↗ |
| K870628 | MICROBOND COMPOSITE KIT FOR CERAMIC BONDING SYSTEM | Chem-E-Dent | 1987-03-06 | Traditional | PDF ↗ |
| K870266 | COLTENE BRILLIANT D.I. DIRECT INLAY SYSTEM | Coltene, Inc. | 1987-02-27 | Traditional | PDF ↗ |
| K865028 | ESPE CHELON-SILVER | Espe GmbH (Us) | 1987-02-19 | Traditional | PDF ↗ |
| K864710 | ISOSIT N | Ivoclar USA, Inc. | 1987-02-10 | Traditional | PDF ↗ |
| K864346 | REMBRANDT PORCELAIN TINTING KIT | Den-Mat Corp. | 1987-01-07 | Traditional | PDF ↗ |
| K863876 | OMNI-FIL | Inpromas | 1986-11-26 | Traditional | PDF ↗ |
| K863882 | OPALUX VISIBLE LIGHT CURED ANTERIOR COMPOSITE | Coe Laboratories, Inc. | 1986-11-18 | Traditional | PDF ↗ |
| K863401 | RECOVER | Scientific Pharmaceuticals, Inc. | 1986-11-13 | Traditional | PDF ↗ |
| K863552 | IMPROVED COMSPAN | Dentsply Intl. | 1986-10-17 | Traditional | PDF ↗ |
| K862546 | MICROFILL PONTIC | Kulzer, Inc. | 1986-10-14 | Traditional | PDF ↗ |
| K863174 | CAULK'S POLISHING PASTE | Dentsply Intl. | 1986-10-07 | Traditional | PDF ↗ |
| K863157 | RESTODENT POSTERIOR | Lee Pharmaceuticals | 1986-09-25 | Traditional | PDF ↗ |
| K863031 | TWIN-CORE | Scientific Pharmaceuticals, Inc. | 1986-09-22 | Traditional | PDF ↗ |
| K863314 | ESTILUX(R) POSTERIOR C | Kulzer, Inc. | 1986-09-22 | Traditional | PDF ↗ |
| K863315 | MULTIFIL(R) VS | Kulzer, Inc. | 1986-09-22 | Traditional | PDF ↗ |
| K863092 | DENTAL COMPOSITE RESTORATIVE | Dentsply Intl. | 1986-09-19 | Traditional | PDF ↗ |
| K862942 | PHOTO CLEARFIL BRIGHT | Kuraray Co. | 1986-09-05 | Traditional | PDF ↗ |
| K862292 | ESPE VISIO-MOLAR | Espe GmbH (Us) | 1986-08-18 | Traditional | PDF ↗ |
| K862232 | PANAVIA TC, AND PANAVIA OPAQUE | Kuraray Co. | 1986-07-29 | Traditional | PDF ↗ |
Product code EBF · Class II · Dental. Data: openFDA.