Home › Device types › ELZ
Crown, Preformed
FDA product code ELZ · Class 1 · Dental
3,797
Registered devices
22
Adverse events
4
Recalls
9
510(k) clearances
Devices with this code
Acero Z1 Molar — Park - Istre, LLCAcero Crowns XT Molar — Park - Istre, LLCNuSmile Signature Posterior Replacement Crown — NUSMILE, LTD.Directa Temporary Polycarbonate Crowns — Directa ABAcero Z1 Molar — Park - Istre, LLC3M™ ESPE™ Iso-Form™ — 3M COMPANYDirecta Temporary Polycarbonate Crowns — Directa ABDirecta FullForm — Directa ABKids-e-crown — KIDS-E-DENTAL LLPNuSmile ZR Narrow Posterior Try-In Crown — NUSMILE, LTD.NuSmile Signature Posterior Replacement Crown — NUSMILE, LTD.Acero Crowns XT Anteriors — Park - Istre, LLCNuSmile ZR Permanent Molar Try-In Crown — NUSMILE, LTD.Implantium, Superline — Dentium Co., Ltd.Henry Schein — HENRY SCHEIN, INC.3M™ ESPE™ Iso-Form™ — 3M COMPANYNuSmile ZR Anterior Replacement Crown — NUSMILE, LTD.Ceramir Pediatric Crown 74/L Size XL — edelweiss dentistry products gmbhDirecta Temporary Polycarbonate Crowns — Directa ABTRANSPARENT CROWNS — TDV DENTAL LTDANuSmile ZR Posterior Replacement Crown — NUSMILE, LTD.3M™ ESPE™ — 3M COMPANYNuSmile ZR Posterior Try-In Crown — NUSMILE, LTD.Acero Crowns-3S Surgical Steel — Park - Istre, LLC
Recent 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 |
| 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 labe |
| 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 Mo |
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