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DuraLock® PLUS Impression Trays
Ortho Organizers, Inc. · Model 640-045 · UDI-DI 00190707099343
EHY
Prescription
10
510(k) clearances
0
Adverse events
3
Recalls
326
Facilities
Description
DuraLock® PLUS Impression Tray - Size: 5 Large, YELLOW Upper
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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