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HomePRACTICON, INC. › ECOsply™ Biodegradable Disposable Impression Trays Large Upper 10/Pack

ECOsply™ Biodegradable Disposable Impression Trays Large Upper 10/Pack

PRACTICON, INC. · Model 7158249 · UDI-DI 00723896030288

EHY
10
510(k) clearances
0
Adverse events
3
Recalls
325
Facilities

Description

Single use impression trays used to take a impression of a patients mouth in a dental setting. 10 per bag

Recalls

DateFirmReason
2016-05-19Implant Direct Sybron Manufacturing, LLCThe 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
2005-09-21Rite-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
2004-10-13Harry J Bosworth CompanyThe 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.