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Essentials by 3D Dental
3D DENTAL DESIGNS AND DEVELOPMENT, LLC · Model BRTQ · UDI-DI 00817169023906
10
510(k) clearances
0
Adverse events
3
Recalls
325
Facilities
Description
BITE REGISTRATION TRAYS 35/BX QUADRANT
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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Get your free API keyRead the docsData 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.