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elements IC

META SYSTEMS CO., LTD. · Model elements IC SYSTEM · UDI-DI 08809455602386

EKR Prescription

510(k) clearances

Adverse events

Recalls

143

Facilities

Description

The cordless elements IC obturation system combines a Downpack heat source with a Backfill extruder. The Downpack device provides fast heating of the heat plugger with precisely controlled temperature and timing, making it suitable for single-motion downpack obturation of the apical portion of the root canal. Utilizing single-use gutta-percha cartridges, the ergonomic Backfill device has a motorized extruder system for precise temperature and speed control for a 3-dimensional obturation of the root canal system.

Recalls

Date	Firm	Reason
2017-12-27	Ormco/Sybronendo	Buchanan Heat Pluggers will possibly overheat while used with the Elements Obturation Unit (EOU).
2013-01-17	Ormco/Sybronendo	A recall has been issued by SybronEndo because a Canadian Standards Association (CSA)-directed cautionary statement label was inadvertently omitted from the Elements Obturation Uni
2013-01-17	Ormco/Sybronendo	A recall has been issued by SybronEndo because a Canadian Standards Association (CSA)-directed cautionary statement label was inadvertently omitted from the Elements Obturation Uni

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.