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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 27, 2017 | Ormco/Sybronendo Elements Obturation Unit (EOU) used with respective Buchanan Heat Pluggers
Device is an endodontic root canal plugger. It is intended to be used in Dentistry to provide continuous heat at the tip of Terminated |
EKR | K031664 |
| Jun 14, 2013 | Ormco/Sybronendo SybronEndo Replacement AC Power Cord, US Elements Obturation; REF 973-0334; SybronEndo, 1332 S. Lone Hill Ave. Glendora, CA 91740; EU Rep: Kerr Italia, S.r.l, Via Passanti, 332, 1-84018 Scafati (SA), Terminated |
EKR | K031664 |
| Jun 14, 2013 | Ormco/Sybronendo SybronEndo Elements Obturation Unit; REF 973-0322; SN 91-1234; 2005-10; SybronEndo, 1332 S. Lone Hill Ave. Glendora, CA 91740; EU Rep: Kerr Italia, S.r.l, Via Passanti, 332, 1-84018 Scafati (SA), Ita Terminated |
EKR | K031664 |
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