Plugger, Root Canal, Endodontic
Regulation 872.4565
0510(k)s in 12 months (6 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in EKR
| Company | 510(k)s | Recalls |
|---|---|---|
| Ormco/Sybronendo | 0 | 3 |
| B&L Biotech Co., Ltd. | 1 | 0 |
| Dentsply Intl. | 1 | 0 |
| Sybron Endo/Analytic | 1 | 0 |
| Techdent, Inc. | 1 | 0 |
| Union Branch | 1 | 0 |
| Young O/S, LLC | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 5, 2006 | K060347 | B&L L-BETA, MODEL WL-B1 B&L Biotech Co., Ltd. | EKR |
| Dec 1, 2004 | K042828 | OBTURA GUTTA PERCHA DELIVERY SYSTEM, MODEL 823-700 Young O/S, LLC | EKR |
| Apr 28, 2004 | K031664 | ELEMENTS OBTURATION UNIT Sybron Endo/Analytic | EKR |
| Mar 26, 1986 | K860569 | ENDODONTIC ROOT CANAL PLUGGER Dentsply Intl. | EKR |
| Jul 12, 1983 | K831748 | ENDODONTIC ROOT CANAL PLUGGER FINGER- Union Branch | EKR |
| Aug 3, 1979 | K791019 | MCSPADDEN CONDENSOR Techdent, Inc. | EKR |
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