3m™ Espe™ Protemp™
3M™ ESPE™ Protemp™ Crown Temporization Material Refill - Bicuspid Upper Large, 50614
23manufacturers in China registered for this device type
12catalogue 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, expiry date |
| Packaging | Box of 10 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 50611 | 5 | In distribution | |
| 50617 | 5 | In distribution | |
| 50600 | 42 | In distribution | |
| 50610 | 5 | In distribution | |
| 50612 | 5 | In distribution | |
| 50614 | 5 | In distribution | |
| 50600CA | 5 | In distribution | |
| 50615 | 5 | In distribution | |
| 50600TK | 5 | In distribution | |
| 50618 | 5 | In distribution | |
| 50613 | 5 | In distribution | |
| 50616 | 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.