Directa Temporary Polycarbonate Crowns
179 catalogue numbers from OP 2, listed by Directa AB, Sweden, under Crown, Preformed. 23 manufacturers in China are registered for this product code.
23manufacturers in China registered for this device type
179catalogue numbers in this listing
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 | Directa AB, Sweden |
|---|---|
| FDA product code | ELZ |
| Device type | Crown, Preformed |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3330 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-12-07 |
| Record revised | 2023-09-08 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Distribution end date | 2023-09-07 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OP 2 | In distribution | |
| OP 103 | In distribution | |
| L1R | In distribution | |
| OP 10 | In distribution | |
| L1L | In distribution | |
| L6R | In distribution | |
| 59 | In distribution | |
| 26 | In distribution | |
| 63 | In distribution | |
| OP 36 | In distribution | |
| 51 | In distribution | |
| OP 56 | In distribution | |
| 25 | In distribution | |
| 22 | In distribution | |
| L7R | In distribution | |
| L2R | In distribution | |
| 49 | In distribution | |
| 32 | In distribution | |
| OP 62 | In distribution | |
| U2L | In distribution | |
| 52 | In distribution | |
| OP 12 | In distribution | |
| OP 11 | In distribution | |
| U3R | In distribution | |
| U9R | In distribution | |
| OP 45 | In distribution | |
| 45 | In distribution | |
| U8R | In distribution | |
| 29 | In distribution | |
| L6L | In distribution | |
| OP 19 | In distribution | |
| L8L | In distribution | |
| OP 66 | In distribution | |
| OP 58 | In distribution | |
| 60 | In distribution | |
| OP 200 | In distribution | |
| 13 | In distribution | |
| OP 24 | In distribution | |
| U1R | In distribution | |
| 66 | In distribution | |
| 40 | In distribution | |
| OP 41 | In distribution | |
| OP 61 | In distribution | |
| 54 | In distribution | |
| OP 60 | In distribution | |
| OP 33 | In distribution | |
| 100 | In distribution | |
| OP 302 | In distribution | |
| L7L | In distribution | |
| OP 46 | In distribution | |
| OP 39 | In distribution | |
| OP 28 | In distribution | |
| OP 27 | In distribution | |
| OP 26 | In distribution | |
| 17 | In distribution | |
| L5R | In distribution | |
| OP 17 | In distribution | |
| OP 21 | In distribution | |
| 46 | In distribution | |
| 21 | In distribution | |
| OP 40 | In distribution | |
| OP 48 | In distribution | |
| 69 | In distribution | |
| 10 | In distribution | |
| OP 102 | In distribution | |
| 43 | In distribution | |
| U5L | In distribution | |
| U7R | In distribution | |
| U6R | In distribution | |
| L5L | In distribution | |
| U4L | In distribution | |
| 19 | In distribution | |
| U3L | In distribution | |
| OP 31 | In distribution | |
| OP 68 | In distribution | |
| 2 | In distribution | |
| 303 | In distribution | |
| 67 | In distribution | |
| OP 65 | In distribution | |
| 57 | In distribution | |
| OP 55 | In distribution | |
| OP 23 | In distribution | |
| 58 | In distribution | |
| 14 | In distribution | |
| 18 | In distribution | |
| OP 63 | In distribution | |
| 101 | In distribution | |
| L3R | In distribution | |
| OP 34 | In distribution | |
| OP 50 | In distribution | |
| 37 | In distribution | |
| OP 64 | In distribution | |
| 15 | In distribution | |
| OP 43 | In distribution | |
| L3L | In distribution | |
| OP 303 | In distribution | |
| OP 53 | In distribution | |
| L9R | In distribution | |
| 50 | In distribution | |
| OP 301 | In distribution | |
| 64 | In distribution | |
| OP 100 | In distribution | |
| U4R | In distribution | |
| L9L | In distribution | |
| 65 | In distribution | |
| OP 52 | In distribution | |
| OP 16 | In distribution | |
| L4L | In distribution | |
| 47 | In distribution | |
| 12 | In distribution | |
| 39 | In distribution | |
| OP 37 | In distribution | |
| 103 | In distribution | |
| U5R | In distribution | |
| 38 | In distribution | |
| 34 | In distribution | |
| 30 | In distribution | |
| 62 | In distribution | |
| OP 44 | In distribution | |
| 24 | In distribution | |
| L2L | In distribution | |
| OP 54 | In distribution | |
| 44 | In distribution | |
| OP 42 | In distribution | |
| U8L | In distribution | |
| 11 | In distribution | |
| OP 30 | In distribution | |
| 31 | In distribution | |
| OP 18 | In distribution | |
| OP 13 | In distribution | |
| OP 67 | In distribution | |
| U2R | In distribution | |
| OP 300 | In distribution | |
| OP 15 | In distribution | |
| 27 | In distribution | |
| L4R | In distribution | |
| 35 | In distribution | |
| 23 | In distribution | |
| OP 20 | In distribution | |
| L8R | In distribution | |
| OP 22 | In distribution | |
| OP 49 | In distribution | |
| OP 47 | In distribution | |
| 300 | In distribution | |
| 33 | In distribution | |
| 200 | In distribution | |
| OP 57 | In distribution | |
| OP 69 | In distribution | |
| 301 | In distribution | |
| 68 | In distribution | |
| OP 29 | In distribution | |
| 48 | In distribution | |
| 302 | In distribution | |
| U7L | In distribution | |
| OP 25 | In distribution | |
| 16 | In distribution | |
| 36 | In distribution | |
| 28 | In distribution | |
| 53 | In distribution | |
| OP 59 | In distribution | |
| OP 14 | In distribution | |
| 56 | In distribution | |
| 55 | In distribution | |
| OP 35 | In distribution | |
| 42 | In distribution | |
| U6L | In distribution | |
| U1L | In distribution | |
| OP 51 | In distribution | |
| 102 | In distribution | |
| 41 | In distribution | |
| OP 101 | In distribution | |
| OP 38 | In distribution | |
| U9L | In distribution | |
| OP 32 | In distribution | |
| 61 | In distribution | |
| 20 | In distribution | |
| Assortment 1-6 | Withdrawn | |
| MO Asstortment | Withdrawn | |
| OP Assortment 1-6 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 3M™ Espe™ | 3M Company | 219 |
| Directa FullForm | Directa AB | 186 |
| 3M™ Unitek™ | 3M Company | 180 |
| 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 |
| Kids-e-crown | Kids-E-Dental LLP | 106 |
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.