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Impression Tray

Kerr Corporation · Model Q17G · UDI-DI 10814978022707

EHY Prescription

510(k) clearances

Adverse events

Recalls

327

Facilities

Description

Clear Impression Trays; Upper Left/Lower Right Clear Trays; 12 Pack

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.