GC Crowntek™
GC CROWNTEK™ Starter Package, 5 crowns each of 35 sizes, Upper Right Central Incisors: 1+.3, 1+.4, 1 +.5, 1+.6, 1+.7, Upper Right Cuspids 3+.5, 3+.6, Upper Left Central Incisors: +1.3,…
GC CROWNTEK™ Starter Package, 5 crowns each of 35 sizes, Upper Right Central Incisors: 1+.3, 1+.4, 1 +.5, 1+.6, 1+.7, Upper Right Cuspids 3+.5, 3+.6, Upper Left Central Incisors: +1.3, _1.4, +1.5, +1.6, +1.7, Upper Left Cuspids: +3.5, +3.6, Upper Right Laterals: 2+.2, 2+.3, 2+.4, 2+.5, Lower Right Cuspids: 3-.3, 3-.4, Upper Left Laterals: +2.2, +2.3, +2.4, +2.5, Lower Left Cuspids: -3.3, -3.4, Lower Centrals & Laterals: -1-2-.6, -1-2-.7, Bicuspids: 2, 3, 4, 5, 6, 7. 8
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 | GC America Inc., United States |
|---|---|
| FDA product code | ELZ |
| Device type | Crown, Preformed |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3330 |
| Establishment | Contract manufacturer, Remanufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2017-02-10 |
| Record revised | 2021-03-10 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Storage | Special storage condition: Room temperature |
| Distribution end date | 2018-05-01 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 412102 | 5 | Withdrawn | |
| 412096 | 5 | Withdrawn | |
| 412089 | 5 | Withdrawn | |
| 412087 | 5 | Withdrawn | |
| 412099 | 5 | Withdrawn | |
| 412071 | 5 | Withdrawn | |
| 412114 | 5 | Withdrawn | |
| 412078 | 5 | Withdrawn | |
| 412124 | 5 | Withdrawn | |
| 412083 | 5 | Withdrawn | |
| 412112 | 5 | Withdrawn | |
| 412090 | 5 | Withdrawn | |
| 412068 | 5 | Withdrawn | |
| 412107 | 5 | Withdrawn | |
| 412106 | 5 | Withdrawn | |
| 412093 | 5 | Withdrawn | |
| 412130 | 5 | Withdrawn | |
| 412064 | 5 | Withdrawn | |
| 412100 | 5 | Withdrawn | |
| 412086 | 5 | Withdrawn | |
| 412072 | 5 | Withdrawn | |
| 412117 | 5 | Withdrawn | |
| 412098 | 5 | Withdrawn | |
| 412128 | 5 | Withdrawn | |
| 412073 | 5 | Withdrawn | |
| 412077 | 5 | Withdrawn | |
| 412118 | 5 | Withdrawn | |
| 412095 | 5 | Withdrawn | |
| 412120 | 5 | Withdrawn | |
| 412111 | 5 | Withdrawn | |
| 412080 | 5 | Withdrawn | |
| 412081 | 5 | Withdrawn | |
| 412076 | 5 | Withdrawn | |
| 412070 | 5 | Withdrawn | |
| 412109 | 5 | Withdrawn | |
| 412126 | 5 | Withdrawn | |
| 412069 | 5 | Withdrawn | |
| 412101 | 5 | Withdrawn | |
| 412123 | 5 | Withdrawn | |
| 412065 | 5 | Withdrawn | |
| 412103 | 5 | Withdrawn | |
| 412125 | 5 | Withdrawn | |
| 412108 | 5 | Withdrawn | |
| 412084 | 5 | Withdrawn | |
| 412129 | 5 | Withdrawn | |
| 412075 | 5 | Withdrawn | |
| 412113 | 5 | Withdrawn | |
| 412122 | 5 | Withdrawn | |
| 412088 | 5 | Withdrawn | |
| 412074 | 5 | Withdrawn | |
| 412097 | 5 | Withdrawn | |
| 412094 | 5 | Withdrawn | |
| 412079 | 5 | Withdrawn | |
| 412110 | 5 | Withdrawn | |
| 412127 | 5 | Withdrawn | |
| 412121 | 5 | Withdrawn | |
| 412092 | 5 | Withdrawn | |
| 412104 | 5 | Withdrawn | |
| 412082 | 5 | Withdrawn | |
| 412115 | 5 | Withdrawn | |
| 412063 | 175 | Withdrawn | |
| 412066 | 5 | Withdrawn | |
| 412105 | 5 | Withdrawn | |
| 412119 | 5 | Withdrawn | |
| 412131 | 5 | Withdrawn | |
| 412132 | 5 | Withdrawn | |
| 412091 | 5 | Withdrawn | |
| 412116 | 5 | Withdrawn | |
| 412133 | 5 | Withdrawn | |
| 412085 | 5 | Withdrawn | |
| 412067 | 5 | Withdrawn |
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
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.