Henry Schein
Premium DNT Base DK Fiber HC (5 LBS 4 PER Case)
14manufacturers in China registered for this device type
59catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (6), Zhejiang (2), Hebei (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Aidite (Qinhuangdao) Technology Co., Ltd. | Qinhuangdao | Hebei | Repacker / relabeller | 17 |
| Shandong Huge Dental Material Corporation | Rizhao | Shandong | Manufacturer | 17 |
| Shen FU Arts LAB | Shen Zhen | Guangdong | Manufacturer | 15 |
| Liaoning Upcera Co., Ltd. | Benxi | Liaoning | Contract manufacturer | 10 |
| Shenzhen Upcera Digital Dental Technology Co., Ltd. | Shenzhen | Guangdong | Exporter | 10 |
| Riton 3D Technology Co., Ltd. | Guangzhou | Guangdong | Repacker / relabeller | 9 |
| Yamahachi Dental Material (Changshu) Co., Ltd. | Changshu | Jiangsu | Manufacturer | 9 |
| Guangzhou Heygears Imc.inc | Guangzhou | Guangdong | Specification developer | 8 |
| Hangzhou SHINING3D Dental Technology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 7 |
| Ningbo Sezen Technology Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 7 |
| Hunan Vsmile Biotechnology Co., Ltd. | Changsha | Hunan | Contract manufacturer | 6 |
| Shenzhen Piocreat 3D Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 6 |
Showing 12 of 14. All 14 manufacturers in China registered for Resin, Denture, Relining, Repairing, Rebasing
Record
| Listed by | Henry Schein, Inc., United States |
|---|---|
| FDA product code | EBI |
| Device type | Resin, Denture, Relining, Repairing, Rebasing |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3760 |
| Premarket notification | Exempt |
| Record published | 2020-01-20 |
| Record revised | 2021-11-10 (version 4) |
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 |
| Storage | Storage environment temperature 32 to 86 °F; Special storage condition: Keep away from moisture |
| Packaging | Case of 4, pack of 4 |
| Sizes | Weight 1 to 25 lb; total volume 1 to 8 Fluid Ounce; total volume 1 Quart; weight 100 g; total volume 110 ml |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5700717 | In distribution | |
| 1127013 | In distribution | |
| 1012492 | Total Volume 4 Fluid Ounce | In distribution |
| 5750020 | Weight 25 lb | In distribution |
| 1013959 | Weight 1 lb | In distribution |
| 1013910 | Weight 1 lb | In distribution |
| 1016706 | Weight 5 lb | In distribution |
| 1014573 | Weight 25 lb | In distribution |
| 1048756 | In distribution | |
| 1011213 | Weight 1 lb | In distribution |
| 1009096 | Weight 5 lb | In distribution |
| 1018232 | Weight 1 lb | In distribution |
| 1006263 | Weight 1 lb | In distribution |
| 1013466 | Weight 5 lb | In distribution |
| 1048757 | In distribution | |
| 1015011 | Weight 5 lb | In distribution |
| 1019276 | Weight 5 lb | In distribution |
| 1013633 | Weight 5 lb | In distribution |
| 5700719 | In distribution | |
| 1011585 | Total Volume 4 Fluid Ounce | In distribution |
| 1011105 | Weight 5 lb | In distribution |
| 1017366 | Weight 1 lb | In distribution |
| 5700454 | Total Volume 1 Quart | In distribution |
| 1002791 | Weight 1 lb | In distribution |
| 1009772 | Weight 1 lb | In distribution |
| 1015188 | Total Volume 1 Quart | In distribution |
| 1019236 | Weight 25 lb | In distribution |
| 1019697 | Weight 25 lb | In distribution |
| 1011303 | Weight 25 lb | In distribution |
| 5750454 | Weight 1 lb | In distribution |
| 5752155 | Weight 5 lb | In distribution |
| 5759553 | Weight 5 lb | In distribution |
| 1018333 | Total Volume 8 Fluid Ounce | In distribution |
| 1012820 | Weight 1 lb | In distribution |
| 2912322 | Bottle | In distribution |
| 1017550 | Total Volume 1 Quart | In distribution |
| 1012823 | Weight 25 lb | In distribution |
| 1010374 | Weight 5 lb | In distribution |
| 1011493 | Weight 1 lb | In distribution |
| 1005646 | Bottle | In distribution |
| 1014923 | Weight 1 lb | In distribution |
| 1013212 | Total Volume 1 Fluid Ounce | In distribution |
| 1015838 | Weight 5 lb | In distribution |
| 5700453 | Total Volume 8 Fluid Ounce | In distribution |
| 5750305 | Weight 1 lb | In distribution |
| 1015054 | Weight 1 lb | In distribution |
| 1014304 | Total Volume 8 Fluid Ounce | In distribution |
| 1010279 | Weight 5 lb | In distribution |
| 1017092 | Weight 5 lb | In distribution |
| 1011810 | Total Volume 1 Quart | In distribution |
| 1015532 | Weight 1 lb | In distribution |
| 1003029 | Bottle | In distribution |
| 5750014 | Weight 1 lb | In distribution |
| 1015561 | Total Volume 8 Fluid Ounce | In distribution |
| 1002851 | Weight 5 lb | In distribution |
| 1002852 | Weight 1 lb | In distribution |
| 5700718 | In distribution | |
| 1013503 | Weight 25 lb | In distribution |
| 1019202 | Weight 5 lb | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vertex-Dental BV | Vertex-Dental B.V. | 760 |
| HI-I® | Fricke International, Inc. | 490 |
| Vitacrilic® | Fricke International, Inc. | 249 |
| Nature-Cryl® | GC America Inc. | 205 |
| Nobilium | Cmp Industries, LLC | 167 |
| Hygenic | Coltene/Whaledent Gmbh & Co. KG | 152 |
| AvaDent | Global Dental Science | 150 |
| Dentorium | Wright Medical Technology, Inc. | 137 |
| Duracetal | The Myerson Company Limited | 136 |
| RE-Fine Bright | Yamahachi Dental MFG. Co. | 134 |
| Axcent Acrylics | Garreco, LLC | 132 |
| Unbreakable by TCS | Thermoplastic Comfort SYS | 96 |
Showing 12 of 3,288. All products under Resin, Denture, Relining, Repairing, Rebasing
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Keystone Industries – Gibbstown | UDI-DI | 2023-04-10 | Class II | Packaging process control | The Hard Line Chairside Reline Kit (570-0718) (0921940HS) was labeled as Soft Line Chairside Reline Kit (570-0717) (0921250HS) on the outer box. The contents of the Kit and the IFU enclosed with the kit were correctly labeled as Hard Line m | 240 units |
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.