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 29, 1996 | K962405 | SANICURE DISPOSABLE CURING PROBE Efos Canada, Inc., CA | EBF |
| Jul 8, 1996 | K961434 | VITA ZETA CROWN AND BRIDGE ACRYLIC VENEERING SYSTEM Vident | EBF |
| Jul 2, 1996 | K960667 | CENTRIX FLOFIL/CENTRIX FLOFIL WITH FLUORIDE Wallace A. Erickson & Co. | EBF |
| May 8, 1996 | K961284 | KOLOR + Sybron Dental Specialties, Inc. | EBF |
| Apr 26, 1996 | K960729 | ENAMEL CONDITIONER (ENAMEL ETCHING AGENT) Dent Zar, Inc. | EBF |
| Apr 26, 1996 | K960600 | LEXUR ENAMEL COATING-PORCELAIN REPAIR-BONDING VENEERS Dent Zar, Inc. | EBF |
| Apr 26, 1996 | K960599 | SUPERIOR PHOTOCURING HYBRID COMPOSITE Dent Zar, Inc. | EBF |
| Apr 26, 1996 | K960598 | CONCORD MARYLAND BRIDGE CEMENT Dent Zar, Inc. | EBF |
| Apr 26, 1996 | K960597 | ORION-1 VL CROWN BASE AND POST CEMENT VISIBLE LIGHT CURE Dent Zar, Inc. | EBF |
| Apr 26, 1996 | K960596 | ORION-I CORE BUILD-UP MATERIAL CHEMICAL CURE Dent Zar, Inc. | EBF |
| Apr 26, 1996 | K960595 | FANTASTIC 1 CONTACT CURE ORTHODONTIC ADHESIVE FOR PLASTIC AND METAL BRACKETS Dent Zar, Inc. | EBF |
| Apr 26, 1996 | K960594 | LIGHT SUPER BOND-1 LIGHT CURED ORTHODONTIC ADHESIVE FOR METAL, PLASTIC AND CERAMIC BRACKETS Dent Zar, Inc. | EBF |
| Mar 22, 1996 | K960565 | ACORN ANTERIOR/POSTERIOR COMPOSITE RESTORATIVE Dent Zar, Inc. | EBF |
| Mar 15, 1996 | K960165 | ALPHA-DENT COMPOSITE SURFACE SEALANT Wallace A. Erickson & Co. | EBF |
| Mar 8, 1996 | K954988 | CRYSTALLESSENCE Confi-Dental Products Co. | EBF |
| Jan 23, 1996 | K955337 | OPAKER Kerr Dental Materials Center | EBF |
| Dec 13, 1995 | K955292 | AELITEFLO Bisco, Inc. | EBF |
| Nov 27, 1995 | K954929 | CHARISMA SINGLE DOSE Heraeus Kulzer, Inc. | EBF |
| Oct 30, 1995 | K954408 | AMERICAN DENTAL PRODUCTS LIGHT ACTIVATED COMPOSITE RESIN CORE BUILDUP BLUE PASTEE American Dental Products, Inc. | EBF |
| Oct 30, 1995 | K954407 | AMERICAN DENTAL PRODUCTS WHITE COMPOSITE RESIN CORE PASTE WITH FLUORIDE American Dental Products, Inc. | EBF |
| Oct 30, 1995 | K954406 | AMERICAN DENTAL PRODUCTS COMPOSITE RESIN CORE PASTE WITH FLUORIDE American Dental Products, Inc. | EBF |
| Oct 30, 1995 | K954405 | AMERICAN DENTAL PRODDUCTS LIGHT ACTIVATED COMPOSITE RESIN CORE PASTE WITH FLUORIDE American Dental Products, Inc. | EBF |
| Oct 16, 1995 | K954461 | AMERICAN DENTAL PRODUCTS CORE BUILDUP PASTE American Dental Products, Inc. | EBF |
| Sep 27, 1995 | K954115 | ARTGLASS & KEVLOC Heraeus Kulzer, Inc. | EBF |
| Aug 28, 1995 | K953525 | ULTRADENT FLOWABLE COMPOSITE Ultradent Products, Inc. | EBF |
| Aug 28, 1995 | K952662 | COMP=FLOW Jeneric/Pentron, Inc. | EBF |
| Aug 10, 1995 | K952353 | EZ-COMP Adm, Inc. | EBF |
| Aug 10, 1995 | K952333 | PLASMA ARC CURING SYSTEM American Dental Technologies, Inc. | EBF |
| Jun 22, 1995 | K952500 | COMPSEAL Jeneric/Pentron, Inc. | EBF |
| May 25, 1995 | K951836 | COMPOLGLASS COMPOGLASS SCA Ivoclar North America, Inc. | EBF |
| May 15, 1995 | K951427 | AMERICAN DENTAL PRODUCTS (ADP), COMPOSITE RESTORATIVE MATERIAL American Dental Products, Inc. | EBF |
| May 12, 1995 | K951426 | AMERICAN DENTAL PRODUCTS (ADP), VISIBLE LIGHT CURE COMPOSITE DENTAL RESTORATIVE MATERIAL American Dental Products, Inc. | EBF |
| Mar 23, 1995 | K950991 | DYRACT II RESTORATIVE Dentsply Intl. | EBF |
| Mar 23, 1995 | K950859 | PERMASEAL Ultradent Products, Inc. | EBF |
| Mar 13, 1995 | K950765 | COMPA LAB-R Robert W. Bauer & Assoc., Inc. | EBF |
| Feb 7, 1995 | K942993 | THERMORESIN LC II GC America, Inc. | EBF |
| Jan 26, 1995 | K946307 | CYRSTALLINE L3 MULTI-USE HYBRID COMPOSITE Confi-Dental Products Co. | EBF |
| Dec 29, 1994 | K945769 | TOTAL ETCH GEL Dentsply Intl. | EBF |
| Dec 29, 1994 | K945539 | OPTIGUARD Sybron Dental Specialties, Inc. | EBF |
| Dec 29, 1994 | K945364 | DYRACT(TM) MATERIAL Denstply Detrey-Dedent | EBF |
| Dec 15, 1994 | K945173 | PULPDENT HARDSHELL Pulpdent Corp. | EBF |
| Dec 14, 1994 | K945113 | PULPDENT CERVICAL RESTORATIVE Pulpdent Corp. | EBF |
| Dec 14, 1994 | K945058 | PULPDENT MICROFILLED ANTERIOR COMPOSITE Pulpdent Corp. | EBF |
| Dec 14, 1994 | K945057 | PULPDENT HYBRID ANTERIOR COMPOSITE Pulpdent Corp. | EBF |
| Dec 14, 1994 | K945056 | PULPDENT RESIN CEMENT Pulpdent Corp. | EBF |
| Dec 14, 1994 | K945018 | PULPDENT HARD DENTAL POSTERIOR FILLING MATERIAL Pulpdent Corp. | EBF |
| Dec 8, 1994 | K944659 | PRODIGY Sybron Dental Specialties, Inc. | EBF |
| Nov 17, 1994 | K943642 | HERCULITE XR & XRV Sybron Dental Specialties, Inc. | EBF |
| Aug 10, 1994 | K943169 | CLEARFIL AP-X AND LINER BOND 2 Kuraray Company, Ltd. | EBF |
| Aug 10, 1994 | K943168 | CLEARFIL AP-X Kuraray Company, Ltd. | EBF |
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