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ODUS "PELLA" Transparent CROWN FORMS - Assortment of 36 crowns
Produits dentaires S.A. · Model 33405d · UDI-DI 07640159160458
ELZ
Prescription
9
510(k) clearances
22
Adverse events
4
Recalls
134
Facilities
Description
18 pairs (right and left) as described in the crown form chart (size 1, 11, 21, 31, 41, 51, 101, 111, 121, 131, 2, 12, 22, 32, 3, 13, 23, 5)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2013-08-05 | 3M Company/3m Espe Dental Products | 3M ESPE is recalling Unitek Primary Stainless Steel Crowns (First Primary UL4) because these products have been manufactured with the incorrect marginal contour edge. |
| 2013-06-05 | 3M Company - Health Care Business | 3M is recalling specific lots of 3M ESPE Unitek Primary Stainless Steel Crowns - Series UR4 contain LL3 crowns which are incorrectly labeled as UR4 crowns. |
| 2010-10-06 | 3M Company / Medical Division | Unitek Stainless Steel Permanent Crowns with product Codes 902150, 900213, and 900223, is mislabeled. The crown contained within the package is incorrectly labeled; series UL3 crow |
| 2007-10-17 | 3M Company / Medical Division | Mislabeled: Unitek Stainless Steel Permanent Molar Crowns were placed in packaging which incorrectly identified the product as Unitek Stainless Steel Primary Molar Crowns. |
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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.