Material, Tooth Shade, Resin
Regulation 872.3690
18510(k)s in 12 months (937 all time)
2recalls in 12 months (71 all time)
71recalls that name a 510(k)
Top companies in EBF
| Company | 510(k)s | Recalls |
|---|---|---|
| Kerr Corp. | 9 | 43 |
| Voco GmbH | 45 | 1 |
| Sybron Dental Specialties | 28 | 7 |
| Bisco, Inc. | 30 | 0 |
| Pulpdent Corp. | 29 | 0 |
| Scientific Pharmaceuticals, Inc. | 29 | 0 |
| Dentsply Intl. | 28 | 0 |
| Ivoclar North America, Inc. | 28 | 0 |
| Shofu Dental Corp. | 27 | 0 |
| GC America, Inc. | 24 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 1, 1988 | K881903 | PROSTHODENT VL Lee Pharmaceuticals | EBF |
| Jun 13, 1988 | K882006 | CLEARFIL PHOTO CORE Kuraray Co. | EBF |
| Apr 18, 1988 | K880765 | G-CERA PORCELAIN BOND G-C Intl. Corp. | EBF |
| Mar 10, 1988 | K875313 | PORCELAIN VENEER RESIN CEMENT W/DUAL CURE CATALYST Bisco, Inc. | EBF |
| Mar 2, 1988 | K872588 | CLEARFIL PHOTO POSTERIOR Kuraray Co. | EBF |
| Feb 26, 1988 | K875256 | BISCOLOR Bisco, Inc. | EBF |
| Feb 11, 1988 | K874189 | DUAL-CURE RADIOPAQUE Pentron Corp. | EBF |
| Jan 20, 1988 | K873123 | LEE COMPOSITE INLAY SYSTEM Lee Pharmaceuticals | EBF |
| Jan 19, 1988 | K874275 | OPTEC SUPPLEMENTARY KIT Pentron Corp. | EBF |
| Jan 12, 1988 | K874162 | OPTEC STAIN CHARACTERIZATION AND MODIFICATION KIT Pentron Corp. | EBF |
| Nov 16, 1987 | K873683 | CODE #23 R SYSTEM (DENTIN ADHESIVE MATERIAL) Pentron Corp. | EBF |
| Nov 12, 1987 | K873886 | CLEARFIL PORCELAIN REPAIR SYSTEM Kuraray Co. | EBF |
| Oct 27, 1987 | K873878 | #24L SYSTEM Pentron Corp. | EBF |
| Sep 11, 1987 | K872444 | SILUX PLUS LIGHT CURED RESTORATIVE MATERIAL 3M Company | EBF |
| Aug 24, 1987 | K872510 | DEN-MAT TENURE Den-Mat Corp. | EBF |
| Aug 11, 1987 | K872960 | CLEARFIL POSTERIOR NEW BOND Kuraray Co. | EBF |
| Aug 3, 1987 | K872907 | DENTIN ADHESIVE Dentsply Intl. | EBF |
| Aug 3, 1987 | K872890 | SYNERGY Scientific Pharmaceuticals, Inc. | EBF |
| Jul 21, 1987 | K872569 | TEMREX ETCHING GEL Scientific Pharmaceuticals, Inc. | EBF |
| Jul 21, 1987 | K871899 | IMPERVA-A Shofu Dental Corp. | EBF |
| Jul 21, 1987 | K871898 | IMPERVA-P Shofu Dental Corp. | EBF |
| Jul 17, 1987 | K871637 | CLEARFIL CORE NEW BOND Kuraray Co. | EBF |
| Jul 17, 1987 | K871634 | CLEARFIL FII NEW BOND Kuraray Co. | EBF |
| Jul 16, 1987 | K871635 | CLEARFIL POSTERIOR 3 Kuraray Co. | EBF |
| Jul 7, 1987 | K872243 | PEKALUX(TM) Columbus Dental Mfg. Co. | EBF |
| Jul 2, 1987 | K872279 | SCOTCHBOND 2 ADHESIVE W/SCOTCHPREP DENTIN PRIMER 3M Company | EBF |
| Jul 2, 1987 | K872272 | PEKALUX/GLUMA LIGHT CURED ANTERIOR RESTORATIVE SYS Columbus Dental Mfg. Co. | EBF |
| Jul 2, 1987 | K871164 | GLUMA(TM) BONDING SYSTEM Columbus Dental Mfg. Co. | EBF |
| May 29, 1987 | K871295 | ADAPTALITE* PORCELAIN VENEER CEMENTATION SYSTEM Johnson & Johnson Professionals, Inc. | EBF |
| May 29, 1987 | K871270 | PERFORM DENTURE BASE RESIN Ipco Corp. | EBF |
| Apr 3, 1987 | K871165 | LUMIFOR(TM) COMPOSITE Columbus Dental Mfg. Co. | EBF |
| Mar 6, 1987 | K870628 | MICROBOND COMPOSITE KIT FOR CERAMIC BONDING SYSTEM Chem-E-Dent | EBF |
| Feb 27, 1987 | K870266 | COLTENE BRILLIANT D.I. DIRECT INLAY SYSTEM Coltene, Inc. | EBF |
| Feb 19, 1987 | K865028 | ESPE CHELON-SILVER Espe GmbH (Us) | EBF |
| Feb 10, 1987 | K864710 | ISOSIT N Ivoclar USA, Inc. | EBF |
| Jan 7, 1987 | K864346 | REMBRANDT PORCELAIN TINTING KIT Den-Mat Corp. | EBF |
| Nov 26, 1986 | K863876 | OMNI-FIL Inpromas | EBF |
| Nov 18, 1986 | K863882 | OPALUX VISIBLE LIGHT CURED ANTERIOR COMPOSITE Coe Laboratories, Inc. | EBF |
| Nov 13, 1986 | K863401 | RECOVER Scientific Pharmaceuticals, Inc. | EBF |
| Oct 17, 1986 | K863552 | IMPROVED COMSPAN Dentsply Intl. | EBF |
| Oct 14, 1986 | K862546 | MICROFILL PONTIC Kulzer, Inc. | EBF |
| Oct 7, 1986 | K863174 | CAULK'S POLISHING PASTE Dentsply Intl. | EBF |
| Sep 25, 1986 | K863157 | RESTODENT POSTERIOR Lee Pharmaceuticals | EBF |
| Sep 22, 1986 | K863315 | MULTIFIL(R) VS Kulzer, Inc. | EBF |
| Sep 22, 1986 | K863314 | ESTILUX(R) POSTERIOR C Kulzer, Inc. | EBF |
| Sep 22, 1986 | K863031 | TWIN-CORE Scientific Pharmaceuticals, Inc. | EBF |
| Sep 19, 1986 | K863092 | DENTAL COMPOSITE RESTORATIVE Dentsply Intl. | EBF |
| Sep 5, 1986 | K862942 | PHOTO CLEARFIL BRIGHT Kuraray Co. | EBF |
| Aug 18, 1986 | K862292 | ESPE VISIO-MOLAR Espe GmbH (Us) | EBF |
| Jul 29, 1986 | K862232 | PANAVIA TC, AND PANAVIA OPAQUE Kuraray Co. | EBF |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.