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3M™ ESPE™ Protemp™
3M COMPANY · Model 50610 · UDI-DI 30605861007239
ELZ
Prescription
9
510(k) clearances
22
Adverse events
4
Recalls
134
Facilities
Description
3M™ ESPE™ Protemp™ Crown Temporization Material Refill - Molar Upper Large, 50610
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.