Vitallium®
7 catalogue numbers from 2000 Alloy, listed by Dentsply LLC, United States, under Alloy, Metal, Base. 24 manufacturers in China are registered for this product code.
24manufacturers in China registered for this device type
7catalogue numbers in this listing
5510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (11), Jiangsu (7), Shanghai (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Digital Dental Depot | Zhuhai | Guangdong | Contract manufacturer | 17 |
| Shenzhen Jiahong Dental Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 7 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
| Shanghai Smedent Medical Instrument Co., Ltd. | Shanghai | Shanghai | Repacker / relabeller | 30 |
| Fseven Dental Technology Zhuhai Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 18 |
| Shenzhen Sunmc Dental Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 17 |
| Shen FU Arts LAB | Shen Zhen | Guangdong | Manufacturer | 15 |
| Shenzhen HLD Dental&Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 14 |
| Shenzhen Times Dental LAB | Shenzhen | Guangdong | Manufacturer | 13 |
| Qinhuangdao Audental Metal Technology Co., Ltd. | Qinhuangdao | Hebei | Manufacturer | 11 |
| Smile Dental Laboratory Company Limited | Zhuhai | Guangdong | Manufacturer | 11 |
| Riton 3D Technology Co., Ltd. | Guangzhou | Guangdong | Repacker / relabeller | 9 |
Showing 12 of 24. All 24 manufacturers in China registered for Alloy, Metal, Base
Record
| Listed by | Dentsply LLC, United States |
|---|---|
| FDA product code | EJH |
| Device type | Alloy, Metal, Base |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3710 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2017-01-31 |
| Record revised | 2022-05-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Sizes | Weight 500 to 1000 g; weight 1 kg; length 2.75 in |
| Distribution end date | 2022-05-05 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 2000 Alloy | Weight 500 g | In distribution | |
| Alloy | Weight 1000 g | In distribution | |
| 2000 Plus Alloy | Weight 500 g | In distribution | |
| III Alloy | Weight 1 kg | Withdrawn | |
| 2 Alloy | Weight 1000 g | Withdrawn | |
| Nickel-Free Welding Rod | Length 2.75 in | 5 | Withdrawn |
| 5 Alloy | Weight 1 kg | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Nobilium | Cmp Industries, LLC | 239 |
| Zirlux | Henry Schein, Inc. | 69 |
| remanium® | Dentaurum GmbH & Co. KG | 56 |
| Magnum Splendidum | Mesa DI Sala Giacomo & C. SNC | 47 |
| Ceramill Sintron® | Amann Girrbach AG | 47 |
| Magnum Solare | Mesa DI Sala Giacomo & C. SNC | 37 |
| Base metal alloy | Institut Straumann AG | 34 |
| Luminesse Ti-Cam Discs | Talladium, Inc. | 33 |
| Starbond CoS | S & S Scheftner GmbH | 24 |
| Dentorium | Wright Medical Technology, Inc. | 23 |
| Starbond Easy | S & S Scheftner GmbH | 22 |
| Magnum Hyperone | Mesa DI Sala Giacomo & C. SNC | 21 |
Showing 12 of 627. All products under Alloy, Metal, Base
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K860437 | 1986-03-17 |
| K842551 | 1984-08-02 |
| K833512 | 1983-12-27 |
| K820328 | 1982-03-02 |
| K811258 | 1981-07-23 |
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.