510(k) K031664 ยท EKR Plugger, Root Canal, Endodontic
ELEMENTS OBTURATION UNIT
| Applicant | Sybron Endo/Analytic, Redmond WA, US |
| Decision | Substantially Equivalent, Apr 28, 2004 |
| Received | May 29, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031664
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.