Qu-Resin Dentine Color
Qu-resin dentine color 1 Assortment
7manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (3), Hebei (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Jiahong Dental Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 7 |
| Qinhuangdao Audental Metal Technology Co., Ltd. | Qinhuangdao | Hebei | Manufacturer | 11 |
| Nanjing Chamlion Laser Technology Co., Ltd. | Nanjing | Jiangsu | Manufacturer | 7 |
| FOO Tian Dental Laboratory | Shenzhen | Guangdong | Manufacturer | 6 |
| Xiao Fei Dental Manufacture (Chengdu) Co., Ltd. | Chengdu | Sichuan | Remanufacturer | 5 |
| Guangzhou Jinguanqiao Industry Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 4 |
| Xi’an Sinotitanium Metals Co., Ltd. | Xi An | Shaanxi | Manufacturer | 2 |
Record
| Listed by | Bredent Gmbh & Co.kg, Germany |
|---|---|
| FDA product code | EKO |
| Device type | Denture Preformed (Partially Prefabricated Denture) |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3600 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-09-07 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: keep out of sunlight |
| Packaging | Dummy |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 54001162 | In distribution | |
| 54001166 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Baltic Denture System BDLoad | Merz Dental Gmbh | 3,152 |
| Baltic Denture System BD Load | Merz Dental Gmbh | 1,039 |
| Good Fit Instant Overdentures | Good FIT Technologies, LLC | 84 |
| Good Fit Instant Denture Setups | Good FIT Technologies, LLC | 84 |
| Stellar DC Acrylic | Taub Products | 5 |
| Baltic Denture System BD Key | Merz Dental Gmbh | 4 |
| Baltic Denture System Bdkey Pmma | Merz Dental Gmbh | 3 |
| Stellar iJig | Taub Products | 3 |
| Baltic Denture System BD Key Lock | Merz Dental Gmbh | 2 |
| Qu-resin dentin | Bredent Gmbh & Co.kg | 2 |
| Qu-resin pink | Bredent Gmbh & Co.kg | 2 |
| Baltic Denture System BDStarterSet | Merz Dental Gmbh | 2 |
Showing 12 of 27. All products under Denture Preformed (Partially Prefabricated Denture)
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.