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 |
|---|---|---|---|
| Aug 14, 1990 | K901869 | DEGUFILL (R) H Degussa AG, DE | EBF |
| Aug 14, 1990 | K901868 | DEGUFILL (R) M Degussa AG, DE | EBF |
| Aug 13, 1990 | K902745 | DEGUFILL (TM) Degussa AG | EBF |
| Aug 9, 1990 | K900510 | PERTAC-HYBRID Espe GmbH (Us) | EBF |
| Aug 1, 1990 | K902743 | DEGUFILL (TM) ETCHANT GEL Degussa AG | EBF |
| Aug 1, 1990 | K901872 | DEGUFILL (R) ETCHANT Degussa AG, DE | EBF |
| Jun 28, 1990 | K901917 | DUAL CEMENT Ivoclar North America, Inc. | EBF |
| Jun 28, 1990 | K901914 | HELIO PROGRESS (DENTAL COMPOSITE) Ivoclar North America, Inc. | EBF |
| Jun 26, 1990 | K901918 | HELIOTINT Ivoclar North America, Inc. | EBF |
| Jun 26, 1990 | K901910 | HELIO LINK (RESIN CEMENT) Ivoclar North America, Inc. | EBF |
| Jun 22, 1990 | K901916 | SPECIAL BOND Ivoclar North America, Inc. | EBF |
| Jun 15, 1990 | K901697 | SILISTOR CERAMIC AND RESIN REPAIR SYSTEM Kulzer, Inc. | EBF |
| May 25, 1990 | K896469 | EOS INLAY MATERIAL Ivoclar North America, Inc. | EBF |
| May 15, 1990 | K901396 | CONCEPT INLAY/ONLAY Ivoclar North America, Inc. | EBF |
| May 15, 1990 | K897011 | PALFIQUE LIGHT-S COMPOSITE RESIN Tokuyama America, Inc. | EBF |
| May 15, 1990 | K897010 | PALFIQUE LIGHT COMPOSITE RESIN Tokuyama America, Inc. | EBF |
| May 15, 1990 | K896769 | INTERFACE BONDING SYSTEM Smile Horizons, Inc. | EBF |
| May 7, 1990 | K896530 | FERMIT TEMPORARY MATERIAL Ivoclar North America, Inc. | EBF |
| Apr 30, 1990 | K901051 | 22% POLYACRYLIC ACID GEL Pulpdent Corp. | EBF |
| Apr 13, 1990 | K900690 | CLEARFIL VENEER BOND KIT Kuraray Co. | EBF |
| Mar 13, 1990 | K896950 | CORE BUILD UP COMPOSITE Confi-Dental Products Co. | EBF |
| Feb 14, 1990 | K896662 | AIR BLOCK Pulpdent Corp. | EBF |
| Feb 14, 1990 | K896658 | DENTIN DISCLOSING GEL AND GEL REMOVER Pulpdent Corp. | EBF |
| Feb 14, 1990 | K896654 | DRYING AGENT Pulpdent Corp. | EBF |
| Feb 14, 1990 | K896653 | SEPARATING MEDIUM (POLYVINYL ALCOHOL) Pulpdent Corp. | EBF |
| Feb 9, 1990 | K896564 | DENTAL CORE MATERIAL Dentsply Intl. | EBF |
| Jan 10, 1990 | K896132 | ENAMEL PREP ENAMEL ETCHANT (EMAIL-PREPARATOR GS) Ivoclar North America, Inc. | EBF |
| Dec 22, 1989 | K895976 | TOOTH SHADE RESIN G-C Intl. Corp. | EBF |
| Dec 4, 1989 | K895401 | NORTHERNLIGHTS ORTHODONTIC BONDING SYSTEM Rocky Mountain Orthodontics, Inc. | EBF |
| Oct 27, 1989 | K894890 | CRYSTALLINE C2 AND CRYSTALLINE L3 Confi-Dental Products Co. | EBF |
| Oct 20, 1989 | K894644 | CROWN AND BRIDGE DENTAL RESTORATIVE COMPOSITE SYST Jeneric/Pentron, Inc. | EBF |
| Jun 22, 1989 | K892455 | KULZER ADHESIVE CEMENT Kulzer, Inc. | EBF |
| Jun 16, 1989 | K892454 | KULZER INLAY SYSTEM Kulzer, Inc. | EBF |
| Jun 9, 1989 | K891698 | ZAROLAN, DUALAN, TITAN AND SUPERON Dent Zar, Inc. | EBF |
| May 26, 1989 | K891020 | ESPE TULUX-CEM Espe GmbH (Us) | EBF |
| May 19, 1989 | K891463 | ADHERENCE M5 MULTI-CURE COMPOSITE CEMENT SYSTEM Confi-Dental Products Co. | EBF |
| Mar 31, 1989 | K890123 | CLEARFIL CR INLAY Kuraray Co. | EBF |
| Mar 29, 1989 | K890140 | PHOSPHORIC-ACID ETCHING GEL Centrix, Inc. | EBF |
| Jan 27, 1989 | K884588 | HELIOMOLAR(R) DENTAL RESTORATIVE Williams Dental Co., Inc. | EBF |
| Jan 3, 1989 | K884681 | UNIREST LC PAINT-ON RESTORATIVE & VENEER CEMENT Scientific Pharmaceuticals, Inc. | EBF |
| Jan 3, 1989 | K884391 | PREMET, METAL PRIMER Scientific Pharmaceuticals, Inc. | EBF |
| Jan 3, 1989 | K884350 | UNIREST COMPOSITE RESTORATIVE, SELF CURED Scientific Pharmaceuticals, Inc. | EBF |
| Dec 28, 1988 | K884351 | UNIREST PL, ANTE./POST. RESTORATIVE, PASTE/LIQUID Scientific Pharmaceuticals, Inc. | EBF |
| Dec 22, 1988 | K884352 | SMILE-DENT ANTE./POST. RESTORATIVE, LIGHT-CURED Scientific Pharmaceuticals, Inc. | EBF |
| Dec 7, 1988 | K884038 | FIBERLITE, FIBERLITE HS AND FIBERSEAL Jeneric/Pentron, Inc. | EBF |
| Oct 19, 1988 | K882566 | VISIO-PERL Espe GmbH (Us) | EBF |
| Oct 18, 1988 | K883392 | LUMINBOND, BONDING AND CEMENTATION SYSTEM Scientific Pharmaceuticals, Inc. | EBF |
| Aug 12, 1988 | K882915 | FORTIFY Bisco, Inc. | EBF |
| Jul 15, 1988 | K882576 | ACID ETCH GEL Pulpdent Corp. of America | EBF |
| Jul 15, 1988 | K882400 | AMORPHUS SILK BY DENTRAX Dale T. Dupuis | EBF |
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