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YDM CORPORATION · Model 19082 · UDI-DI 04963931190829

EHY

510(k) clearances

Adverse events

Recalls

325

Facilities

Description

A horseshoe-shaped receptacle made of metal designed to carry dental impression material to the mouth, to confine the material in opposition to the surfaces to be recorded (e.g., teeth and gums), and to control the impression material while it sets to form an impression.

Recalls

Date	Firm	Reason
2016-05-19	Implant Direct Sybron Manufacturing, LLC	The incorrect sized product, InterActive Implant Open-Tray Transfer Wide, 6534-08W, was packaged instead of the InterActive Implant Open-tray Transfer Narrow, 6534-08N, causing a p
2005-09-21	Rite-Dent Manufacturing Corp.	At least two of the ingredients used in the production of these products were not intended for human use. The ingredients are not listed in the master formula for these products no
2004-10-13	Harry J Bosworth Company	The tray mold was improperly made such that the plastic trays do not conform to the shape of the patient's mouth.

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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.