Hiro Light Cure Pattern, Modeling and Indexing Resin
Light Cure Pattern, Modeling and Indexing Resin.
7manufacturers in China registered for this device type
1catalogue number
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 | Denali Corporation, United States |
|---|---|
| FDA product code | EKO |
| Device type | Denture Preformed (Partially Prefabricated Denture) |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3600 |
| Premarket notification | Exempt |
| Record published | 2018-01-09 |
| Record revised | 2023-06-12 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 2 |
| Distribution end date | 2023-01-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| One 3 mL Syringe | Withdrawn |
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 |
| Qu-resin dentine color | Bredent Gmbh & Co.kg | 2 |
| 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 |
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.