Bosworth New Truliner
New Truliner PEMA 3 oz P & 1 oz L Mini Kit Clear
14manufacturers in China registered for this device type
26catalogue numbers in this listing
8510(k) clearances naming this product code
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 | Harry J. Bosworth Co., 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 | 2016-09-15 |
| Record revised | 2018-08-09 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep away from moisture; Special storage condition: Keep out of direct sunlight |
| Sizes | Total volume 10 to 236 ml; weight 85 to 454 g; total volume 1 to 128 Fluid Ounce; weight 1 to 5 lb; weight 2.27 kg; total volume 1 Gallon |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0921980 | Weight 1 lb | In distribution |
| 0921973 | Weight 227 g | In distribution |
| 0921978 | In distribution | |
| 0921975 | Weight 227 g | In distribution |
| 0921989 | In distribution | |
| 0921984 | Total Volume 118 ml | In distribution |
| 0921985C | In distribution | |
| 0921976 | Total Volume 177 ml | In distribution |
| 0921971 | In distribution | |
| 0921977 | In distribution | |
| 0921983 | Total Volume 10 ml | In distribution |
| 0921985V | In distribution | |
| 0921992 | Weight 5 lb | In distribution |
| 0921997 | Total Volume 1 Gallon | In distribution |
| 0921990 | In distribution | |
| 0921970 | In distribution | |
| 0921993 | Weight 2.27 kg | In distribution |
| 0921991 | Weight 2.27 kg | In distribution |
| 0921686 | Total Volume 118 ml | In distribution |
| 0921987 | Total Volume 30 ml | In distribution |
| 0921783 | Weight 85 g | In distribution |
| 0921986 | Total Volume 236 ml | In distribution |
| 0921985 | In distribution | |
| 0921972 | In distribution | |
| 0921974 | Weight 227 g | In distribution |
| 0921988 | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K990699 | 1999-05-17 |
| K981862 | 1999-02-09 |
| K981691 | 1998-11-03 |
| K981861 | 1998-10-01 |
| K961200 | 1996-05-17 |
| K946317 | 1995-02-16 |
| K842576 | 1984-09-27 |
| K840405 | 1984-05-01 |
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.