Nacera® Pearl Natural
The Nacera® Pearl Natural zirconium dioxide milling blank made of yttrium-stabilized zirconium dioxide (5Y-TZP + 3Y-TZP) is a hybridlayer and is suitable for dental application of type II,…
The Nacera® Pearl Natural zirconium dioxide milling blank made of yttrium-stabilized zirconium dioxide (5Y-TZP + 3Y-TZP) is a hybridlayer and is suitable for dental application of type II, class 5 in accordance with DIN EN ISO 6872 and they fulfill their material-specific requirements after specified final sintering.
33manufacturers in China registered for this device type
133catalogue numbers in this listing
5510(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 | Dental Direkt GmbH, Germany |
|---|---|
| FDA product code | EIH |
| Device type | Powder, Porcelain |
| Device class | Class 2 |
| Regulation | 21 CFR 872.6660 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K241579 |
| Record published | 2024-10-01 |
| Record revised | 2025-12-08 (version 2) |
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 |
| Sizes | Outer diameter 98.3 mm; height 12 to 30 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 98H30 B1 | Outer Diameter 98.3 mm | In distribution |
| 98H30 A4 | Outer Diameter 98.3 mm | In distribution |
| 98H25 0M3 | Outer Diameter 98.3 mm | In distribution |
| 98H12 D3 | Outer Diameter 98.3 mm | In distribution |
| 98H20 0M2 | Outer Diameter 98.3 mm | In distribution |
| 98H18 D2 | Outer Diameter 98.3 mm | In distribution |
| 98H14 B3 | Outer Diameter 98.3 mm | In distribution |
| 98H16 A3.5 | Outer Diameter 98.3 mm | In distribution |
| 98H14 Stellar White | Outer Diameter 98.3 mm | In distribution |
| 98H20 A3.5 | Outer Diameter 98.3 mm | In distribution |
| 98H12 A1 | Outer Diameter 98.3 mm | In distribution |
| 98H16 B1 | Outer Diameter 98.3 mm | In distribution |
| 98H12 Stellar White | Outer Diameter 98.3 mm | In distribution |
| 98H16 C2 | Outer Diameter 98.3 mm | In distribution |
| 98H14 A3.5 | Outer Diameter 98.3 mm | In distribution |
| 98H25 D3 | Outer Diameter 98.3 mm | In distribution |
| 98H16 0M3 | Outer Diameter 98.3 mm | In distribution |
| 98H16 B4 | Outer Diameter 98.3 mm | In distribution |
| 98H18 C3 | Outer Diameter 98.3 mm | In distribution |
| 98H14 D3 | Outer Diameter 98.3 mm | In distribution |
| 98H16 D2 | Outer Diameter 98.3 mm | In distribution |
| 98H30 A3.5 | Outer Diameter 98.3 mm | In distribution |
| 98H16 A4 | Outer Diameter 98.3 mm | In distribution |
| 98H25 A2 | Outer Diameter 98.3 mm | In distribution |
| 98H25 B4 | Outer Diameter 98.3 mm | In distribution |
| 98H30 C1 | Outer Diameter 98.3 mm | In distribution |
| 98H14 B1 | Outer Diameter 98.3 mm | In distribution |
| 98H18 B3 | Outer Diameter 98.3 mm | In distribution |
| 98H18 0M3 | Outer Diameter 98.3 mm | In distribution |
| 98H14 A1 | Outer Diameter 98.3 mm | In distribution |
| 98H20 A3 | Outer Diameter 98.3 mm | In distribution |
| 98H18 C1 | Outer Diameter 98.3 mm | In distribution |
| 98H12 A3 | Outer Diameter 98.3 mm | In distribution |
| 98H12 D4 | Outer Diameter 98.3 mm | In distribution |
| 98H25 B3 | Outer Diameter 98.3 mm | In distribution |
| 98H14 D4 | Outer Diameter 98.3 mm | In distribution |
| 98H18 D4 | Outer Diameter 98.3 mm | In distribution |
| 98H14 A3 | Outer Diameter 98.3 mm | In distribution |
| 98H16 C1 | Outer Diameter 98.3 mm | In distribution |
| 98H20 C2 | Outer Diameter 98.3 mm | In distribution |
| 98H20 D4 | Outer Diameter 98.3 mm | In distribution |
| 98H25 A3 | Outer Diameter 98.3 mm | In distribution |
| 98H12 D2 | Outer Diameter 98.3 mm | In distribution |
| 98H25 C2 | Outer Diameter 98.3 mm | In distribution |
| 98H14 C3 | Outer Diameter 98.3 mm | In distribution |
| 98H25 A4 | Outer Diameter 98.3 mm | In distribution |
| 98H20 A1 | Outer Diameter 98.3 mm | In distribution |
| 98H30 0M2 | Outer Diameter 98.3 mm | In distribution |
| 98H12 B2 | Outer Diameter 98.3 mm | In distribution |
| 98H16 0M2 | Outer Diameter 98.3 mm | In distribution |
| 98H30 C2 | Outer Diameter 98.3 mm | In distribution |
| 98H20 C1 | Outer Diameter 98.3 mm | In distribution |
| 98H14 A4 | Outer Diameter 98.3 mm | In distribution |
| 98H18 B4 | Outer Diameter 98.3 mm | In distribution |
| 98H20 B1 | Outer Diameter 98.3 mm | In distribution |
| 98H20 A2 | Outer Diameter 98.3 mm | In distribution |
| 98H25 Stellar White | Outer Diameter 98.3 mm | In distribution |
| 98H20 D2 | Outer Diameter 98.3 mm | In distribution |
| 98H25 B1 | Outer Diameter 98.3 mm | In distribution |
| 98H12 0M3 | Outer Diameter 98.3 mm | In distribution |
| 98H12 A2 | Outer Diameter 98.3 mm | In distribution |
| 98H25 D4 | Outer Diameter 98.3 mm | In distribution |
| 98H25 B2 | Outer Diameter 98.3 mm | In distribution |
| 98H16 B2 | Outer Diameter 98.3 mm | In distribution |
| 98H30 D3 | Outer Diameter 98.3 mm | In distribution |
| 98H12 C1 | Outer Diameter 98.3 mm | In distribution |
| 98H20 B4 | Outer Diameter 98.3 mm | In distribution |
| 98H16 D3 | Outer Diameter 98.3 mm | In distribution |
| 98H30 B2 | Outer Diameter 98.3 mm | In distribution |
| 98H16 A1 | Outer Diameter 98.3 mm | In distribution |
| 98H14 A2 | Outer Diameter 98.3 mm | In distribution |
| 98H30 A2 | Outer Diameter 98.3 mm | In distribution |
| 98H12 C2 | Outer Diameter 98.3 mm | In distribution |
| 98H14 0M2 | Outer Diameter 98.3 mm | In distribution |
| 98H18 A4 | Outer Diameter 98.3 mm | In distribution |
| 98H12 C4 | Outer Diameter 98.3 mm | In distribution |
| 98H25 A1 | Outer Diameter 98.3 mm | In distribution |
| 98H25 C1 | Outer Diameter 98.3 mm | In distribution |
| 98H18 D3 | Outer Diameter 98.3 mm | In distribution |
| 98H12 B4 | Outer Diameter 98.3 mm | In distribution |
| 98H18 0M2 | Outer Diameter 98.3 mm | In distribution |
| 98H18 A3.5 | Outer Diameter 98.3 mm | In distribution |
| 98H30 C3 | Outer Diameter 98.3 mm | In distribution |
| 98H20 B2 | Outer Diameter 98.3 mm | In distribution |
| 98H14 B4 | Outer Diameter 98.3 mm | In distribution |
| 98H14 C2 | Outer Diameter 98.3 mm | In distribution |
| 98H18 A2 | Outer Diameter 98.3 mm | In distribution |
| 98H25 0M2 | Outer Diameter 98.3 mm | In distribution |
| 98H12 0M2 | Outer Diameter 98.3 mm | In distribution |
| 98H30 A1 | Outer Diameter 98.3 mm | In distribution |
| 98H30 C4 | Outer Diameter 98.3 mm | In distribution |
| 98H20 C4 | Outer Diameter 98.3 mm | In distribution |
| 98H16 C3 | Outer Diameter 98.3 mm | In distribution |
| 98H18 A3 | Outer Diameter 98.3 mm | In distribution |
| 98H12 B3 | Outer Diameter 98.3 mm | In distribution |
| 98H20 D3 | Outer Diameter 98.3 mm | In distribution |
| 98H20 A4 | Outer Diameter 98.3 mm | In distribution |
| 98H20 Stellar White | Outer Diameter 98.3 mm | In distribution |
| 98H30 D4 | Outer Diameter 98.3 mm | In distribution |
| 98H18 C2 | Outer Diameter 98.3 mm | In distribution |
| 98H30 Stellar White | Outer Diameter 98.3 mm | In distribution |
| 98H12 A3.5 | Outer Diameter 98.3 mm | In distribution |
| 98H25 D2 | Outer Diameter 98.3 mm | In distribution |
| 98H12 C3 | Outer Diameter 98.3 mm | In distribution |
| 98H18 A1 | Outer Diameter 98.3 mm | In distribution |
| 98H18 B1 | Outer Diameter 98.3 mm | In distribution |
| 98H30 A3 | Outer Diameter 98.3 mm | In distribution |
| 98H14 0M3 | Outer Diameter 98.3 mm | In distribution |
| 98H20 B3 | Outer Diameter 98.3 mm | In distribution |
| 98H14 C4 | Outer Diameter 98.3 mm | In distribution |
| 98H16 D4 | Outer Diameter 98.3 mm | In distribution |
| 98H18 C4 | Outer Diameter 98.3 mm | In distribution |
| 98H30 0M3 | Outer Diameter 98.3 mm | In distribution |
| 98H20 C3 | Outer Diameter 98.3 mm | In distribution |
| 98H16 Stellar White | Outer Diameter 98.3 mm | In distribution |
| 98H30 D2 | Outer Diameter 98.3 mm | In distribution |
| 98H30 B3 | Outer Diameter 98.3 mm | In distribution |
| 98H16 C4 | Outer Diameter 98.3 mm | In distribution |
| 98H25 C4 | Outer Diameter 98.3 mm | In distribution |
| 98H25 C3 | Outer Diameter 98.3 mm | In distribution |
| 98H14 C1 | Outer Diameter 98.3 mm | In distribution |
| 98H20 0M3 | Outer Diameter 98.3 mm | In distribution |
| 98H16 A2 | Outer Diameter 98.3 mm | In distribution |
| 98H16 A3 | Outer Diameter 98.3 mm | In distribution |
| 98H18 Stellar White | Outer Diameter 98.3 mm | In distribution |
| 98H12 B1 | Outer Diameter 98.3 mm | In distribution |
| 98H12 A4 | Outer Diameter 98.3 mm | In distribution |
| 98H16 B3 | Outer Diameter 98.3 mm | In distribution |
| 98H25 A3.5 | Outer Diameter 98.3 mm | In distribution |
| 98H18 B2 | Outer Diameter 98.3 mm | In distribution |
| 98H14 B2 | Outer Diameter 98.3 mm | In distribution |
| 98H30 B4 | Outer Diameter 98.3 mm | In distribution |
| 98H14 D2 | Outer Diameter 98.3 mm | 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 |
|---|---|
| K241579 | 2024-09-06 |
| K193588 | 2020-04-16 |
| K183569 | 2019-02-14 |
| K170885 | 2017-08-01 |
| K150196 | 2015-03-26 |
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.