PressCeramic
PressCeramic MT A3.5 /4
33manufacturers in China registered for this device type
59catalogue numbers in this listing
2510(k) clearances naming this product code
1recall
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 | Sagemax Bioceramics, Inc., United States |
|---|---|
| FDA product code | EIH |
| Device type | Powder, Porcelain |
| Device class | Class 2 |
| Regulation | 21 CFR 872.6660 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2023-08-21 |
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 |
|---|---|---|---|
| PressCeramic MT A2 /4 | 4 | In distribution | |
| PressCeramic HT A4 /4 | 4 | In distribution | |
| PressCeramic MT B1 /4 | 4 | In distribution | |
| PressCeramic MT BL4 /4 | 4 | In distribution | |
| PressCeramic LT C1 /4 | 4 | In distribution | |
| PressCeramic MT A1 /4 | 4 | In distribution | |
| PressCeramic LT BL3 /4 | 4 | In distribution | |
| PressCeramic HT A3 /4 | 4 | In distribution | |
| PressCeramic HT C4 /4 | 4 | In distribution | |
| PressCeramic LT B4 /4 | 4 | In distribution | |
| PressCeramic HT D4 /4 | 4 | In distribution | |
| PressCeramic MT C2 /4 | 4 | In distribution | |
| PressCeramic HT BL3 /4 | 4 | In distribution | |
| PressCeramic LT D4 /4 | 4 | In distribution | |
| PressCeramic LT A1 /4 | 4 | In distribution | |
| PressCeramic LT B2 /4 | 4 | In distribution | |
| PressCeramic HT BL1 /4 | 4 | In distribution | |
| PressCeramic HT BL2 /4 | 4 | In distribution | |
| PressCeramic MO 4 /4 | 4 | In distribution | |
| PressCeramic MT C1 /4 | 4 | In distribution | |
| PressCeramic MT BL2 /4 | 4 | In distribution | |
| PressCeramic LT C3 /4 | 4 | In distribution | |
| PressCeramic MT BL3 /4 | 4 | In distribution | |
| PressCeramic HT A2 /4 | 4 | In distribution | |
| PressCeramic LT A2 /4 | 4 | In distribution | |
| PressCeramic HT D2 /4 | 4 | In distribution | |
| PressCeramic HT BL4 /4 | 4 | In distribution | |
| PressCeramic HT C1 /4 | 4 | In distribution | |
| PressCeramic LT A4 /4 | 4 | In distribution | |
| PressCeramic LT BL1 /4 | 4 | In distribution | |
| PressCeramic MT A3.5 /4 | 4 | In distribution | |
| PressCeramic MO 3 /4 | 4 | In distribution | |
| PressCeramic LT BL2 /4 | 4 | In distribution | |
| PressCeramic LT C4 /4 | 4 | In distribution | |
| PressCeramic LT BL4 /4 | 4 | In distribution | |
| PressCeramic HT C3 /4 | 4 | In distribution | |
| PressCeramic LT D2 /4 | 4 | In distribution | |
| PressCeramic LT D3 /4 | 4 | In distribution | |
| PressCeramic HT C2 /4 | 4 | In distribution | |
| PressCeramic LT B1 /4 | 4 | In distribution | |
| PressCeramic HT A1 /4 | 4 | In distribution | |
| PressCeramic LT B3 /4 | 4 | In distribution | |
| PressCeramic Opal 2 /4 | 4 | In distribution | |
| PressCeramic MT D2 /4 | 4 | In distribution | |
| PressCeramic Opal 1 /4 | 4 | In distribution | |
| PressCeramic HT D3 /4 | 4 | In distribution | |
| PressCeramic LT C2 /4 | 4 | In distribution | |
| PressCeramic MO 2 /4 | 4 | In distribution | |
| PressCeramic LT A3.5 /4 | 4 | In distribution | |
| PressCeramic HT A3.5 /4 | 4 | In distribution | |
| PressCeramic HT B2 /4 | 4 | In distribution | |
| PressCeramic MT A3 /4 | 4 | In distribution | |
| PressCeramic HT B1 /4 | 4 | In distribution | |
| PressCeramic MO 0 /4 | 4 | In distribution | |
| PressCeramic HT B4 /4 | 4 | In distribution | |
| PressCeramic MT B2 /4 | 4 | In distribution | |
| PressCeramic LT A3 /4 | 4 | In distribution | |
| PressCeramic HT B3 /4 | 4 | In distribution | |
| PressCeramic MO 1 /4 | 4 | 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 |
|---|---|
| K130991 | 2014-02-10 |
| K062695 | 2006-10-20 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2025-12-11 | Class II | Process control | Yttrium-stabilized zirconium oxide discs for fixed all-ceramic dental restorations may have reduced or missing dentin layer and when used clinically in the patient’s mouth there is an increased risk of fractures under functional stress. | 113 |
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.