Home › Device types › ELZ
Crown, Preformed
FDA product code ELZ · Class 1 · Dental
3,912
Registered devices
23
Adverse events
4
Recalls
9
510(k) clearances
Devices with this code
NuSmile ReVIVE Crowns — NUSMILE, LTD.NuSmile Signature Posterior Replacement Crown — NUSMILE, LTD.NuSmile ReVIVE Crowns — NUSMILE, LTD.3M™ ESPE™ — 3M COMPANYSafco polycarbonate crowns — SAFCO DENTAL SUPPLY CO.Directa FullForm — Directa ABNuSmile ReVIVE Crowns — NUSMILE, LTD.NuSmile ZR Posterior Try-In Crown — NUSMILE, LTD.3M™ Unitek™ — 3M COMPANYNuSmile Signature Cuspid Replacement Crown — NUSMILE, LTD.Directa Temporary Polycarbonate Crowns — Directa ABNuSmile Signature Posterior Pediatric Basic Kit "D" Crowns — NUSMILE, LTD.NuSmile Signature Anterior Replacement Crown — NUSMILE, LTD.NuSmile ZR Anterior Replacement Crown — NUSMILE, LTD.3M™ Unitek™ — 3M COMPANYEZCrown — Sprig Oral Health Technologies, Inc.NuSmile Signature Posterior Replacement Crown — NUSMILE, LTD.Denovo Stainless Steel Primary Molar Crown — Denovo Dental, Inc.Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLCHenry Schein — HENRY SCHEIN, INC.NuSmile Signature Posterior Replacement Crown — NUSMILE, LTD.NuSmile Signature Posterior Replacement Crown — NUSMILE, LTD.NuSmile ZR Posterior Replacement Crown — NUSMILE, LTD.Bioflx Crown — KIDS-E-DENTAL LLP
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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