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Elements Gutta Percha Cartridge 10 PCS

META SYSTEMS CO., LTD. · Model Gutta Percha, Light body 25 Gauge · UDI-DI 08809455601730

EKM Prescription

510(k) clearances

128

Adverse events

Recalls

106

Facilities

Description

The Elements™ Gutta Percha Cartridge (The Gutta Percha Cartridge) is a device that contains gutta-percha material. It is used in conjunction with the Backfill Unit of elements™ IC obturation device or with the Extruder Handpiece of the elements Obturation Unit™. The gutta-percha material is heated and extruded from the cartridge to obturate the root canal as part of an endodontic treatment procedure. The Gutta Percha Cartridge is available in Light 25 gauge, and Medium, Heavy body in 23 gauge.

Recalls

Date	Firm	Reason
2016-02-08	Ormco/Sybronendo	Ormco Corporation is recalling the TF Adaptive Gutta Percha Point Size SM3-50pk because the inner generic label is identified as ML3. The products outer package is identified as S
2010-09-09	Ormco Corporation	The recall was initiated because SybronEndo has confirmed that the Microseal Master Cones has been mislabeled.
2009-10-27	Sybronendo	The recall was initiated because during the manufacturing process of the affected units, the molding process resulted in lock nuts that did not have the level of acceptability requ

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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.