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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32669, 10 PACK UNIDOSE PREMISE A3 OPAQUE, dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32668, 10 PACK UNIDOSE PREMISE A2 OPAQUE, dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32667, 10 PACK UNIDOSE PREMISE XL2, dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32666, 10 PACK UNIDOSE PREMISE XL1, dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32665, 10 PACK UNIDOSE PREMISE D4, dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32664, 10 PACK UNIDOSE PREMISE D3, dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32663, 10 PACK UNIDOSE PREMISE D2, dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32662, 10 PACK UNIDOSE PREMISE C4, dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32661, 10 PACK UNIDOSE PREMISE C3, dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32660, 10 PACK UNIDOSE PREMISE C2, dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32659, 10 PACK UNIDOSE PREMISE C1, dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32658, 10 PACK UNIDOSE PREMISE B4, dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32657, 10 PACK UNIDOSE PREMISE B3, dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32656, 10 PACK UNIDOSE PREMISE B2, dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32655, 10 PACK UNIDOSE PREMISE B1, dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32654, 10 PACK UNIDOSE PREMISE A4, dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32653, 10 PACK UNIDOSE PREMISE A3.5, dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32652, 10 PACK UNIDOSE PREMISE A3, dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32651, 10 PACK UNIDOSE PREMISE A2, dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32650, 10 PACK UNIDOSE PREMISE A1, dental composite Terminated |
EBF | K060472 |
| May 11, 2007 | 3M Espe Dental Products 3M ESPE Rely X Veneer Cement Refill Syringes, A3 Opaque/Yellow Opaque Shade, manufactured by 3M. ESPE is a radiopaque , color stable light-cured resin cement indicated for bonding veneers fabricate Terminated |
EBF | K991961 |
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