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Aidite 3D Printing Model Resin

Aidite (Qinhuangdao) Technology Co., Ltd. · Model APMR01 · UDI-DI 06976459492014

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

Description

For making dental models

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.