Tilite Ceramic Alloys – Star
1 oz. of Tilite (Star)
24manufacturers in China registered for this device type
2catalogue numbers in this listing
1510(k) clearance
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 | Talladium, Inc., United States |
|---|---|
| FDA product code | EJH |
| Device type | Alloy, Metal, Base |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3710 |
| Establishment | Manufacturer |
| 510(k) | K894085 |
| Record published | 2016-10-24 |
| Record revised | 2022-11-30 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 102 | In distribution | |
| 102-5 | In distribution |
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 |
|---|---|
| K894085 | 1989-12-20 |
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.