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Harmony Anterior Disposable Dual Arch Tray
HO DENTAL COMPANY LLC · Model Anterior · UDI-DI 00850211006083
10
510(k) clearances
0
Adverse events
3
Recalls
325
Facilities
Description
Anterior Dual Arch Impression Tray for Dental Use Disposable, Rigid, Alignment Sticks included to mark facial Mid-Line 40/box
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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