RAYZir FS
85 catalogue numbers from FH C14 B4, listed by Vatech mcis Co., Ltd., South Korea, under Powder, Porcelain. 33 manufacturers in China are registered for this product code.
33manufacturers in China registered for this device type
85catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (10), Hunan (6), Hebei (3). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| BMF Tech (Zhuhai) Inc. | Zhuhai | Guangdong | Contract manufacturer | 2 |
| Jiangxi Rekonova Dental Materials Co., Ltd. | Jiujiang | Jiangxi | Contract manufacturer | 1 |
| Aidite (Qinhuangdao) Technology Co., Ltd. | Qinhuangdao | Hebei | Repacker / relabeller | 17 |
| Shandong Huge Dental Material Corporation | Rizhao | Shandong | Manufacturer | 17 |
| Chengdu Besmile Medical Technology Co., Ltd. | Chengdu | Sichuan | Manufacturer | 14 |
| Qinhuangdao Audental Metal Technology Co., Ltd. | Qinhuangdao | Hebei | Manufacturer | 11 |
| Liaoning Upcera Co., Ltd. | Benxi | Liaoning | Contract manufacturer | 10 |
| Shenzhen Upcera Digital Dental Technology Co., Ltd. | Shenzhen | Guangdong | Exporter | 10 |
| Rizhao Huge Biomaterials Company, Ltd. | Rizhao | Shandong | Manufacturer | 7 |
| Shenzhen Yurucheng Dental Materials Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 6 |
| Hunan Vsmile Biotechnology Co., Ltd. | Changsha | Hunan | Contract manufacturer | 6 |
| Deprag High Tech Materials ( Zhengzhou ) Co., Ltd. | Zhangzhou | Henan | Manufacturer | 6 |
Showing 12 of 33. All 33 manufacturers in China registered for Powder, Porcelain
Record
| Listed by | Vatech mcis Co., Ltd., South Korea |
|---|---|
| FDA product code | EIH |
| Device type | Powder, Porcelain |
| Device class | Class 2 |
| Regulation | 21 CFR 872.6660 |
| Establishment | Manufacturer |
| 510(k) | K203590 |
| Record published | 2024-04-22 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| FH C14 B4 | 5 | In distribution | |
| FH C16 B3 | 5 | In distribution | |
| FH C14 C2M | 5 | In distribution | |
| FH I12 A1M | 5 | In distribution | |
| FH I12 B2 | 5 | In distribution | |
| FH C16 D2M | 5 | In distribution | |
| FH C14 D3 | 5 | In distribution | |
| FH I12 A3.5M | 5 | In distribution | |
| FH C16 C1 | 5 | In distribution | |
| FH C14 C4M | 5 | In distribution | |
| FH C14 C3M | 5 | In distribution | |
| FH C14 C4 | 5 | In distribution | |
| FH I12 D3 | 5 | In distribution | |
| FH C14 B4M | 5 | In distribution | |
| FH I12 C2 | 5 | In distribution | |
| FH C14 D3M | 5 | In distribution | |
| FH C16 C1M | 5 | In distribution | |
| FH C14 B3 | 5 | In distribution | |
| FH I12 D4 | 5 | In distribution | |
| FH C16 A2 | 5 | In distribution | |
| FH C14 A3 | 5 | In distribution | |
| FH C14 B2M | 5 | In distribution | |
| FH I12 C3 | 5 | In distribution | |
| FH C14 A3.5 | 5 | In distribution | |
| FH C16 D4 | 5 | In distribution | |
| FH C16 B1 | 5 | In distribution | |
| FH C14 C3 | 5 | In distribution | |
| FH C16 A1 | 5 | In distribution | |
| FH C14 C2 | 5 | In distribution | |
| FH C14 D2 | 5 | In distribution | |
| FH C16 A3.5 | 5 | In distribution | |
| FH C14 A2 | 5 | In distribution | |
| FH C14 C1 | 5 | In distribution | |
| FH C14 A4M | 5 | In distribution | |
| FH I12 A3 | 5 | In distribution | |
| FH C16 C3M | 5 | In distribution | |
| FH C16 B3M | 5 | In distribution | |
| FH I12 A4M | 5 | In distribution | |
| FH C16 A3 | 5 | In distribution | |
| FH C16 B2M | 5 | In distribution | |
| FH I12 D2 | 5 | In distribution | |
| FH C14 D2M | 5 | In distribution | |
| FH C16 C2 | 5 | In distribution | |
| FH C16 A1M | 5 | In distribution | |
| FH I12 A4 | 5 | In distribution | |
| FH C14 A1 | 5 | In distribution | |
| FH C16 B4 | 5 | In distribution | |
| FH C14 A1M | 5 | In distribution | |
| FH C14 D4 | 5 | In distribution | |
| FH I12 A1 | 5 | In distribution | |
| FH C16 D3 | 5 | In distribution | |
| FH C16 C4M | 5 | In distribution | |
| FH I12 A2 | 5 | In distribution | |
| FH C14 A4 | 5 | In distribution | |
| FH I12 A3M | 5 | In distribution | |
| FH C14 B1M | 5 | In distribution | |
| FH C14 A2M | 5 | In distribution | |
| FH C14 B1 | 5 | In distribution | |
| FH I12 C1 | 5 | In distribution | |
| FH C16 D2 | 5 | In distribution | |
| FH C14 C1M | 5 | In distribution | |
| FH C16 B2 | 5 | In distribution | |
| FH I12 A2M | 5 | In distribution | |
| FH C16 B1M | 5 | In distribution | |
| FH C16 A4M | 5 | In distribution | |
| FH C16 A3M | 5 | In distribution | |
| FH C16 C2M | 5 | In distribution | |
| FH C16 A2M | 5 | In distribution | |
| FH C16 C4 | 5 | In distribution | |
| FH C16 D4M | 5 | In distribution | |
| FH C16 A3.5M | 5 | In distribution | |
| FH C14 A3M | 5 | In distribution | |
| FH C14 D4M | 5 | In distribution | |
| FH I12 B3 | 5 | In distribution | |
| FH C14 B3M | 5 | In distribution | |
| FH I12 B1 | 5 | In distribution | |
| FH C14 B2 | 5 | In distribution | |
| FH I12 C4 | 5 | In distribution | |
| FH C14 A3.5M | 5 | In distribution | |
| FH C16 D3M | 5 | In distribution | |
| FH C16 B4M | 5 | In distribution | |
| FH I12 A3.5 | 5 | In distribution | |
| FH C16 C3 | 5 | In distribution | |
| FH I12 B4 | 5 | In distribution | |
| FH C16 A4 | 5 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bloomden | Bloomden Bioceramics (Hunan) Co., Ltd. | 6,340 |
| Upcera Dental Zirconia Blank For Aesthetic Restoration | Liaoning Upcera Co., Ltd. | 4,367 |
| Aidite | Aidite (Qinhuangdao) Technology Co., Ltd. | 4,310 |
| Luxen 5G | Dentalmax Co., Ltd. | 3,903 |
| GC Initial™ | GC America Inc. | 2,724 |
| Gradual Dental Zirconia Blank | Liaoning Upcera Co., Ltd. | 2,035 |
| Multi M Series | Dmax Co., Ltd. | 1,854 |
| Zirconia Dental Ceramics | Chengdu Besmile Medical Technology Co., Ltd. | 1,828 |
| Amber® Mill Q | Hass Corp. | 1,602 |
| Upcera Dental Zirconia Pre-Shaded Blank | Liaoning Upcera Co., Ltd. | 1,498 |
| BruxZir | Prismatik Dentalcraft, Inc. | 1,295 |
| ceraMotion® | Dentaurum GmbH & Co. KG | 1,062 |
Showing 12 of 10,017. All products under Powder, Porcelain
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K223029 | 2023-06-20 |
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.