Zmaxx T Series
186 catalogue numbers from Zmaxx T-Lite Q22, listed by Dmax 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
186catalogue numbers in this listing
2510(k) clearances naming this product code
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 | Dmax Co., Ltd., South Korea |
|---|---|
| FDA product code | EIH |
| Device type | Powder, Porcelain |
| Device class | Class 2 |
| Regulation | 21 CFR 872.6660 |
| Establishment | Contract manufacturer, Manufacturer |
| Record published | 2017-05-29 |
| Record revised | 2018-07-24 (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, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| Zmaxx T-Lite Q22 | In distribution | ||
| Zmaxx T-Lite W10 | In distribution | ||
| Zmaxx T-Pure Z16 | In distribution | ||
| Zmaxx T-Dark D12 | In distribution | ||
| Zmaxx T-Dark W14 | In distribution | ||
| Zmaxx T-Lite Z22 | In distribution | ||
| Zmaxx T-Dark K22 base package | 2 | In distribution | |
| Zmaxx T-Dark C40 base package | 6 | In distribution | |
| Zmaxx T-Pure C40 base package | 6 | In distribution | |
| Zmaxx T-Dark Z30 | In distribution | ||
| Zmaxx T-Dark C55 base package | 4 | In distribution | |
| Zmaxx T-Lite W14 | In distribution | ||
| Zmaxx T-Lite T14 | In distribution | ||
| Zmaxx T-Pure T18 | In distribution | ||
| Zmaxx T-Pure D20 | In distribution | ||
| Zmaxx T-Pure T22 | In distribution | ||
| Zmaxx T-Dark K14 base package | 2 | In distribution | |
| Zmaxx T-Lite D20 | In distribution | ||
| Zmaxx T-Dark W12 | In distribution | ||
| Zmaxx T-Pure Z10 | In distribution | ||
| Zmaxx T-Dark C65 base package | 4 | In distribution | |
| Zmaxx T-Dark T25 | In distribution | ||
| Zmaxx T-Pure K12 base package | 2 | In distribution | |
| Zmaxx T-Lite B16 base package | 4 | In distribution | |
| Zmaxx T-Lite K22 base package | 2 | In distribution | |
| Zmaxx T-Dark Q16 | In distribution | ||
| Zmaxx T-Pure T12 | In distribution | ||
| Zmaxx T-Pure Z14 | In distribution | ||
| Zmaxx T-Pure T16 | In distribution | ||
| Zmaxx T-Lite W22 | In distribution | ||
| Zmaxx T-Pure W10 | In distribution | ||
| Zmaxx T-Dark Z20 | In distribution | ||
| Zmaxx T-Lite T10 | In distribution | ||
| Zmaxx T-Pure Z22 | In distribution | ||
| Zmaxx T-Pure Q18 | In distribution | ||
| Zmaxx T-Pure D22 | In distribution | ||
| Zmaxx T-Pure Z25 | In distribution | ||
| Zmaxx T-Dark D10 | In distribution | ||
| Zmaxx T-Lite W25 | In distribution | ||
| Zmaxx T-Lite Q12 | In distribution | ||
| Zmaxx T-Pure Z30 | In distribution | ||
| Zmaxx T-Lite W20 | In distribution | ||
| Zmaxx T-Dark B16 base package | 4 | In distribution | |
| Zmaxx T-Pure Z12 | In distribution | ||
| Zmaxx T-Pure T10 | In distribution | ||
| Zmaxx T-Pure W18 | In distribution | ||
| Zmaxx T-Lite D18 | In distribution | ||
| Zmaxx T-Dark B20 base package | 4 | In distribution | |
| Zmaxx T-Pure Z20 | In distribution | ||
| Zmaxx T-Pure C65 base package | 4 | In distribution | |
| Zmaxx T-Lite A25 | In distribution | ||
| Zmaxx T-Dark B12 base package | 4 | In distribution | |
| Zmaxx T-Dark W25 | In distribution | ||
| Zmaxx T-Lite B12 base package | 4 | In distribution | |
| Zmaxx T-Lite T20 | In distribution | ||
| Zmaxx T-Dark T18 | In distribution | ||
| Zmaxx T-Lite C20 base package | 6 | In distribution | |
| Zmaxx T-Pure K18 base package | 2 | In distribution | |
| Zmaxx T-Dark A22 | In distribution | ||
| Zmaxx T-Pure B18 base package | 4 | In distribution | |
| Zmaxx T-Pure D14 | In distribution | ||
| Zmaxx T-Lite K16 base package | 2 | In distribution | |
| Zmaxx T-Pure Q12 | In distribution | ||
| Zmaxx T-Dark T14 | In distribution | ||
| Zmaxx T-Lite C55 base package | 4 | In distribution | |
| Zmaxx T-Lite W16 | In distribution | ||
| Zmaxx T-Pure W16 | In distribution | ||
| Zmaxx T-Pure W14 | In distribution | ||
| Zmaxx T-Dark W16 | In distribution | ||
| Zmaxx T-Lite A12 | In distribution | ||
| Zmaxx T-Pure W12 | In distribution | ||
| Zmaxx T-Lite A20 | In distribution | ||
| Zmaxx T-Dark T20 | In distribution | ||
| Zmaxx T-Pure K20 base package | 2 | In distribution | |
| Zmaxx T-Dark Q22 | In distribution | ||
| Zmaxx T-Lite T22 | In distribution | ||
| Zmaxx T-Lite C65 base package | 4 | In distribution | |
| Zmaxx T-Dark W20 | In distribution | ||
| Zmaxx T-Dark Z18 | In distribution | ||
| Zmaxx T-Lite Q16 | In distribution | ||
| Zmaxx T-Lite Z16 | In distribution | ||
| Zmaxx T-Pure K16 base package | 2 | In distribution | |
| Zmaxx T-Pure W25 | In distribution | ||
| Zmaxx T-Pure A12 | In distribution | ||
| Zmaxx T-Pure A18 | In distribution | ||
| Zmaxx T-Dark C20 base package | 6 | In distribution | |
| Zmaxx T-Lite Z10 | In distribution | ||
| Zmaxx T-Pure T14 | In distribution | ||
| Zmaxx T-Lite Q20 | In distribution | ||
| Zmaxx T-Pure B22 base package | 4 | In distribution | |
| Zmaxx T-Dark D20 | In distribution | ||
| Zmaxx T-Pure T20 | In distribution | ||
| Zmaxx T-Dark A14 | In distribution | ||
| Zmaxx T-Dark D16 | In distribution | ||
| Zmaxx T-Dark W22 | In distribution | ||
| Zmaxx T-Dark Q12 | In distribution | ||
| Zmaxx T-Dark A12 | In distribution | ||
| Zmaxx T-Lite A14 | In distribution | ||
| Zmaxx T-Pure C55 base package | 4 | In distribution | |
| Zmaxx T-Pure A14 | In distribution | ||
| Zmaxx T-Lite B18 base package | 4 | In distribution | |
| Zmaxx T-Lite T16 | In distribution | ||
| Zmaxx T-Dark A18 | In distribution | ||
| Zmaxx T-Lite T12 | In distribution | ||
| Zmaxx T-Lite K18 base package | 2 | In distribution | |
| Zmaxx T-Pure Q20 | In distribution | ||
| Zmaxx T-Lite T25 | In distribution | ||
| Zmaxx T-Dark K16 base package | 2 | In distribution | |
| Zmaxx T-Lite D22 | In distribution | ||
| Zmaxx T-Dark A16 | In distribution | ||
| Zmaxx T-Dark Q20 | In distribution | ||
| Zmaxx T-Dark D25 | In distribution | ||
| Zmaxx T-Dark Z22 | In distribution | ||
| Zmaxx T-Pure Q16 | In distribution | ||
| Zmaxx T-Lite Q14 | In distribution | ||
| Zmaxx T-Pure D12 | In distribution | ||
| Zmaxx T-Dark D14 | In distribution | ||
| Zmaxx T-Pure T25 | In distribution | ||
| Zmaxx T-Lite W18 | In distribution | ||
| Zmaxx T-Pure A20 | In distribution | ||
| Zmaxx T-Pure D16 | In distribution | ||
| Zmaxx T-Lite Q18 | In distribution | ||
| Zmaxx T-Pure K22 base package | 2 | In distribution | |
| Zmaxx T-Lite A22 | In distribution | ||
| Zmaxx T-Dark K12 base package | 2 | In distribution | |
| Zmaxx T-Dark W10 | In distribution | ||
| Zmaxx T-Pure K14 base package | 2 | In distribution | |
| Zmaxx T-Dark B18 base package | 4 | In distribution | |
| Zmaxx T-Pure B12 base package | 4 | In distribution | |
| Zmaxx T-Lite D16 | In distribution | ||
| Zmaxx T-Lite Z18 | In distribution | ||
| Zmaxx T-Dark D22 | In distribution | ||
| Zmaxx T-Dark Z16 | In distribution | ||
| Zmaxx T-Dark W18 | In distribution | ||
| Zmaxx T-Pure D18 | In distribution | ||
| Zmaxx T-Lite K20 base package | 2 | In distribution | |
| Zmaxx T-Lite A16 | In distribution | ||
| Zmaxx T-Dark T10 | In distribution | ||
| Zmaxx T-Dark Z25 | In distribution | ||
| Zmaxx T-Pure W20 | In distribution | ||
| Zmaxx T-Dark T12 | In distribution | ||
| Zmaxx T-Lite C40 base package | 6 | In distribution | |
| Zmaxx T-Lite K12 base package | 2 | In distribution | |
| Zmaxx T-Pure B14 base package | 4 | In distribution | |
| Zmaxx T-Dark Z12 | In distribution | ||
| Zmaxx T-Lite D10 | In distribution | ||
| Zmaxx T-Lite B14 base package | 4 | In distribution | |
| Zmaxx T-Pure D25 | In distribution | ||
| Zmaxx T-Lite D14 | In distribution | ||
| Zmaxx T-Dark T22 | In distribution | ||
| Zmaxx T-Lite Z14 | In distribution | ||
| Zmaxx T-Lite Z30 | In distribution | ||
| Zmaxx T-Pure C20 base package | 6 | In distribution | |
| Zmaxx T-Lite T18 | In distribution | ||
| Zmaxx T-Dark Z10 | In distribution | ||
| Zmaxx T-Pure Q14 | In distribution | ||
| Zmaxx T-Pure B20 base package | 4 | In distribution | |
| Zmaxx T-Dark T16 | In distribution | ||
| Zmaxx T-Dark A25 | In distribution | ||
| Zmaxx T-Lite Z25 | In distribution | ||
| Zmaxx T-Dark Z14 | In distribution | ||
| Zmaxx T-Dark Q18 | In distribution | ||
| Zmaxx T-Lite A18 | In distribution | ||
| Zmaxx T-Lite D12 | In distribution | ||
| Zmaxx T-Dark K20 base package | 2 | In distribution | |
| Zmaxx T-Pure A25 | In distribution | ||
| Zmaxx T-Pure W22 | In distribution | ||
| Zmaxx T-Dark D18 | In distribution | ||
| Zmaxx T-Dark B22 base package | 4 | In distribution | |
| Zmaxx T-Pure B16 base package | 4 | In distribution | |
| Zmaxx T-Pure A22 | In distribution | ||
| Zmaxx T-Dark B14 base package | 4 | In distribution | |
| Zmaxx T-Lite Z12 | In distribution | ||
| Zmaxx T-Dark K18 base package | 2 | In distribution | |
| Zmaxx T-Lite Z20 | In distribution | ||
| Zmaxx T-Pure A16 | In distribution | ||
| Zmaxx T-Lite B20 base package | 4 | In distribution | |
| Zmaxx T-Lite B22 base package | 4 | In distribution | |
| Zmaxx T-Dark A20 | In distribution | ||
| Zmaxx T-Pure D10 | In distribution | ||
| Zmaxx T-Lite K14 base package | 2 | In distribution | |
| Zmaxx T-Pure Z18 | In distribution | ||
| Zmaxx T-Dark Q14 | In distribution | ||
| Zmaxx T-Pure Q22 | In distribution | ||
| Zmaxx T-Lite W12 | In distribution | ||
| Zmaxx T-Lite D25 | 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 |
|---|---|
| K250826 | 2025-06-12 |
| K173769 | 2018-03-08 |
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.