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 |
|---|---|---|---|
| Jun 9, 1980 | K801237 | REIGNING CROWN-BRIDGE/POLYCARB. RESIN Oki Shiks USA , Ltd. | EBF |
| May 20, 1980 | K801092 | PRISMA-FILL Dentsply Intl. | EBF |
| Mar 12, 1980 | K800439 | ADR COMPOSITE RESTORATIVE Scientific Pharmaceuticals, Inc. | EBF |
| Nov 30, 1979 | K792140 | COMPOSITE RESTORATIVE, PASTE/TYPE Scientific Pharmaceuticals, Inc. | EBF |
| Nov 27, 1979 | K792303 | MW 8000-I Midwest | EBF |
| Nov 27, 1979 | K791602 | SCI-PHARM POLIFIL ANTERIOR RESTORATIVE Scientific Pharmaceuticals, Inc. | EBF |
| Oct 22, 1979 | K790823 | VISIO-DISPERS Espe GmbH (Us) | EBF |
| Sep 12, 1979 | K791318 | MIRADAPT* DENTAL RESTORATIVE Johnson & Johnson Professionals, Inc. | EBF |
| Jul 6, 1979 | K790963 | PAINT-ON RESTORATIVE, LIGHT CURED Scientific Pharmaceuticals, Inc. | EBF |
| Jul 6, 1979 | K790822 | ANTERIOR/POSTERIOR RESTORATIVE LIQUID Scientific Pharmaceuticals, Inc. | EBF |
| Jul 6, 1979 | K790789 | COMPOSITE RESTORATIVE, PASTE/PASTE TYPE Scientific Pharmaceuticals, Inc. | EBF |
| Jun 15, 1979 | K790594 | DENTAL COMPOSITE RESTORATIVE MATERIAL Wallace A. Erickson & Co. | EBF |
| May 16, 1979 | K790585 | FINESSE L.D. Caulk Co. | EBF |
| Apr 10, 1979 | K790439 | CONTACT RESIN Vivadent (Usa), Inc. | EBF |
| Mar 21, 1979 | K782165 | PHASEAFILL Phasealloy | EBF |
| Dec 20, 1978 | K781787 | ISOPLAST Vivadent (Usa), Inc. | EBF |
| Dec 4, 1978 | K781687 | AUROFIL Wallace A. Erickson & Co. | EBF |
| Oct 11, 1978 | K781580 | PERFIT DENTAL RESTORATIVE COMPOSITE Locite Corp. | EBF |
| Aug 18, 1978 | K781293 | RESTORATIVE SYSTEM PROFILE The S. S. White Co. | EBF |
| Jun 22, 1978 | K780965 | NEW RESTODENT Lee Pharmaceuticals | EBF |
| Jun 22, 1978 | K780796 | ZYTRON Premier Dental Products Co. | EBF |
| Jun 14, 1978 | K780833 | ESTIC MICROFILL Degussa Dental, Inc. | EBF |
| Jun 14, 1978 | K780832 | ESTILUX MICROFILL Degussa Dental, Inc. | EBF |
| Jan 3, 1978 | K772279 | FOTOFILL DENTAL RESTORATIVE Johnson & Johnson Professionals, Inc. | EBF |
| Oct 20, 1977 | K771882 | REPLICA DENTAL COMPOSITE-RADIOPAQUE Hoyt Laboratories | EBF |
| Oct 20, 1977 | K771880 | REPLICA DENTAL COMPOSIT Hoyt Laboratories | EBF |
| Sep 6, 1977 | K771654 | NIMETICAP Espe GmbH (Us) | EBF |
| Aug 3, 1977 | K771404 | NUVA-FIL COMPOSITE RESTORATIVE (MODI.) L.D. Caulk Co. | EBF |
| Jul 15, 1977 | K771247 | CORE MATERIAL Star Dental Mfg. Co. | EBF |
| Jul 15, 1977 | K771119 | PASTES, RESTORATIVE & TINTED, DEBTAL Espe Dental Products | EBF |
| Jun 1, 1977 | K770922 | DENTAL RESTORATIVE IN CAPSULES Espe GmbH (Us) | EBF |
| Jan 24, 1977 | K770109 | ENAMELITE ENAMEL COATING Lee Pharmaceuticals | EBF |
| Jan 14, 1977 | K770055 | COMPOSITE RESTORATIVE MATERIAL, PRESTIGE Lee Pharmaceuticals | EBF |
| Nov 15, 1976 | K760979 | COMPOSITE MATERIAL Adp Intl., Inc. | EBF |
| Aug 23, 1976 | K760417 | LEE-FILL ULTRAVIOLET-CURED REST. MAT. Lee Pharmaceuticals | EBF |
| Aug 23, 1976 | K760377 | FILLING, RESIN DENTAL (VYTOL) L.D. Caulk Co. | EBF |
| Aug 11, 1976 | K760369 | POWDERLITE The S. S. White Co. | EBF |
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