3m™ Espe™ Iso-Form™
3M™ ESPE™ Iso-Form™ Temporary Crowns Introductory Kit for Bicuspids, Set with 64 Crowns, BC-64
23manufacturers in China registered for this device type
84catalogue numbers in this listing
3recalls on this code
Who Else Makes It
Concentrated in Guangdong (11), Zhejiang (3), Hong Kong (3).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Wise Medical Device Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 25 |
| Fseven Dental Technology Zhuhai Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 18 |
| Shenzhen Sunmc Dental Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 17 |
| Improve Co., Limited | Lantau Island | Hong Kong | Contract manufacturer | 16 |
| Changsha Easyinsmile Intelligence Technology Co., Ltd. | Changsha | Hunan | Manufacturer | 15 |
| Dentall, Inc. | District | Beijing | Contract manufacturer | 13 |
| Royal Dental Lab | Shenzhen | Guangdong | Manufacturer | 12 |
| Qinhuangdao Audental Metal Technology Co., Ltd. | Qinhuangdao | Hebei | Manufacturer | 11 |
| Hangzhou DTC Medical Apparatus Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 10 |
| Joydenta Dental Laboratory | Shenzhen | Guangdong | Contract manufacturer | 10 |
| Shenzhen Jinyi Medical Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 10 |
| Zhejiang YO Medical Technology Co., Ltd. | Huzhou | Zhejiang | Manufacturer | 10 |
Showing 12 of 23. All 23 manufacturers in China registered for Crown, Preformed
Record
| Listed by | 3M Company, United States |
|---|---|
| FDA product code | ELZ |
| Device type | Crown, Preformed |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3330 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-09-24 |
| Record revised | 2021-03-10 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Packaging | Box of 5, box of 10 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| L-68 | 5 | In distribution | |
| U-76 | 5 | In distribution | |
| L-59 | 5 | In distribution | |
| U-61 | 5 | In distribution | |
| U-79 | 5 | In distribution | |
| L-47 | 5 | In distribution | |
| L-56 | 5 | In distribution | |
| L-69 | 5 | In distribution | |
| L-64 | 5 | In distribution | |
| L-73 | 5 | In distribution | |
| U-41 | 5 | In distribution | |
| L-58 | 5 | In distribution | |
| U-60 | 5 | In distribution | |
| L-42 | 5 | In distribution | |
| MC64 | 64 | In distribution | |
| L-65 | 5 | In distribution | |
| BC64 | 64 | In distribution | |
| L-52 | 5 | In distribution | |
| L-43 | 5 | In distribution | |
| U-67 | 5 | In distribution | |
| U-50 | 5 | In distribution | |
| L-44 | 5 | In distribution | |
| U-59 | 5 | In distribution | |
| L-61 | 5 | In distribution | |
| L-76 | 5 | In distribution | |
| U-68 | 5 | In distribution | |
| U-52 | 5 | In distribution | |
| L-75 | 5 | In distribution | |
| U-51 | 5 | In distribution | |
| L-53 | 5 | In distribution | |
| L-55 | 5 | In distribution | |
| L-78 | 5 | In distribution | |
| L-71 | 5 | In distribution | |
| U-69 | 5 | In distribution | |
| L-41 | 5 | In distribution | |
| L-51 | 5 | In distribution | |
| U-62 | 5 | In distribution | |
| U-56 | 5 | In distribution | |
| U-43 | 5 | In distribution | |
| U-53 | 5 | In distribution | |
| U-44 | 5 | In distribution | |
| U-47 | 5 | In distribution | |
| U-55 | 5 | In distribution | |
| U-77 | 5 | In distribution | |
| U-49 | 5 | In distribution | |
| L-54 | 5 | In distribution | |
| L-50 | 5 | In distribution | |
| U-71 | 5 | In distribution | |
| L-74 | 5 | In distribution | |
| L-40 | 5 | In distribution | |
| U-74 | 5 | In distribution | |
| U-65 | 5 | In distribution | |
| L-60 | 5 | In distribution | |
| L-62 | 5 | In distribution | |
| U-66 | 5 | In distribution | |
| SBB-4-5 | In distribution | ||
| L-70 | 5 | In distribution | |
| L-63 | 5 | In distribution | |
| L-49 | 5 | In distribution | |
| L-48 | 5 | In distribution | |
| U-75 | 5 | In distribution | |
| L-72 | 5 | In distribution | |
| L-57 | 5 | In distribution | |
| U-46 | 5 | In distribution | |
| L-67 | 5 | In distribution | |
| U-57 | 5 | In distribution | |
| L-77 | 5 | In distribution | |
| U-72 | 5 | In distribution | |
| U-70 | 5 | In distribution | |
| U-42 | 5 | In distribution | |
| L-45 | 5 | In distribution | |
| U-64 | 5 | In distribution | |
| U-73 | 5 | In distribution | |
| U-63 | 5 | In distribution | |
| U-40 | 5 | In distribution | |
| U-78 | 5 | In distribution | |
| U-58 | 5 | In distribution | |
| U-48 | 5 | In distribution | |
| L-66 | 5 | In distribution | |
| SMB-6-7 | In distribution | ||
| U-45 | 5 | In distribution | |
| U-54 | 5 | In distribution | |
| L-79 | 5 | In distribution | |
| L-46 | 5 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 3M™ Espe™ | 3M Company | 219 |
| Directa FullForm | Directa AB | 186 |
| 3M™ Unitek™ | 3M Company | 180 |
| Directa Temporary Polycarbonate Crowns | Directa AB | 179 |
| EZCrown | Sprig Oral Health Technologies, Inc. | 157 |
| NuSmile Signature Anterior Replacement Crown | Nusmile, Ltd | 143 |
| NuSmile ReVIVE Crowns | Nusmile, Ltd | 122 |
| Hu-Friedy | HU-Friedy MFG Co., LLC | 121 |
| NuSmile Pre-Contoured Stainless Steel Crown | Nusmile, Ltd | 117 |
| Bioflx Crown | Kids-E-Dental LLP | 115 |
| NuSmile ZR Posterior Replacement Crown | Nusmile, Ltd | 110 |
| NuSmile Signature Posterior Replacement Crown | Nusmile, Ltd | 108 |
Showing 12 of 372. All products under Crown, Preformed
Recalls
1 of these is Class III. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2013-06-05 | Class III | Process control | 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. | 1419 (1325 US, 94 OUS) | 2013-12-11 |
| 2010-10-06 | Not classified | Packaging process control | 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 crowns are labeled series UR3 and vice versa. The lid of the pac | 9819 | 2012-02-04 |
| 2007-10-17 | Not classified | Packaging process control | Mislabeled: Unitek Stainless Steel Permanent Molar Crowns were placed in packaging which incorrectly identified the product as Unitek Stainless Steel Primary Molar Crowns. | 975 | 2008-10-17 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.