Nacera Pearl Shaded 16+2
The Nacera® Pearl Shaded 16+2 zirconium dioxide milling blanks made of yttrium-stabilized zirconium dioxide (3Y-TZP) are suitable for dental applications of type II, class 5 in accordance…
The Nacera® Pearl Shaded 16+2 zirconium dioxide milling blanks made of yttrium-stabilized zirconium dioxide (3Y-TZP) are suitable for dental applications 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
90catalogue 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) | K143071 |
| Record published | 2024-05-28 |
| Record revised | 2025-12-08 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Height 18 to 40 mm; outer diameter 98.3 mm; length 24 to 75.5 mm; width 22 to 24 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 98.3×25 C3 | Outer Diameter 98.3 mm | In distribution |
| 98.3×18 B4 | Outer Diameter 98.3 mm | In distribution |
| 24x24x24 A2 | Length 24 mm | In distribution |
| 24x24x24 C4 | Length 24 mm | In distribution |
| 98.3×18 C2 | Outer Diameter 98.3 mm | In distribution |
| 75.5x40x22 A4 | Length 75.5 mm | In distribution |
| 24x24x24 C3 | Length 24 mm | In distribution |
| 24x24x24 B3 | Length 24 mm | In distribution |
| 75.5x40x22 B3 | Length 75.5 mm | In distribution |
| 98.3×18 B1 | Outer Diameter 98.3 mm | In distribution |
| 75.5x40x22 0M3 | Length 75.5 mm | In distribution |
| 98.3×38 B3 | Outer Diameter 98.3 mm | In distribution |
| 75.5x40x22 A2 | Length 75.5 mm | In distribution |
| 75.5x40x22 A3 | Length 75.5 mm | In distribution |
| 75.5x40x22 A1 | Length 75.5 mm | In distribution |
| 98.3×25 C4 | Outer Diameter 98.3 mm | In distribution |
| 24x24x24 C1 | Length 24 mm | In distribution |
| 98.3×25 B4 | Outer Diameter 98.3 mm | In distribution |
| 98.3×38 A4 | Outer Diameter 98.3 mm | In distribution |
| 98.3×38 D2 | Outer Diameter 98.3 mm | In distribution |
| 98.3×25 0M2 | Outer Diameter 98.3 mm | In distribution |
| 98.3×25 C1 | Outer Diameter 98.3 mm | In distribution |
| 75.5x40x22 B4 | Length 75.5 mm | In distribution |
| 98.3×38 A3.5 | Outer Diameter 98.3 mm | In distribution |
| 24x24x24 B2 | Length 24 mm | In distribution |
| 24x24x24 A3.5 | Length 24 mm | In distribution |
| 75.5x40x22 B2 | Length 75.5 mm | In distribution |
| 98.3×18 D3 | Outer Diameter 98.3 mm | In distribution |
| 98.3×25 B2 | Outer Diameter 98.3 mm | In distribution |
| 75.5x40x22 D3 | Length 75.5 mm | In distribution |
| 24x24x24 0M3 | Length 24 mm | In distribution |
| 98.3×18 A3 | Outer Diameter 98.3 mm | In distribution |
| 98.3×38 A3 | Outer Diameter 98.3 mm | In distribution |
| 98.3×18 C3 | Outer Diameter 98.3 mm | In distribution |
| 98.3×38 B1 | Outer Diameter 98.3 mm | In distribution |
| 75.5x40x22 A3.5 | Length 75.5 mm | In distribution |
| 24x24x24 A1 | Length 24 mm | In distribution |
| 24x24x24 A4 | Length 24 mm | In distribution |
| 98.3×18 A2 | Outer Diameter 98.3 mm | In distribution |
| 24x24x24 D4 | Length 24 mm | In distribution |
| 98.3×38 0M3 | Outer Diameter 98.3 mm | In distribution |
| 24x24x24 D2 | Length 24 mm | In distribution |
| 98.3×38 C3 | Outer Diameter 98.3 mm | In distribution |
| 98.3×25 B1 | Outer Diameter 98.3 mm | In distribution |
| 98.3×38 C1 | Outer Diameter 98.3 mm | In distribution |
| 98.3×38 A2 | Outer Diameter 98.3 mm | In distribution |
| 98.3×25 B3 | Outer Diameter 98.3 mm | In distribution |
| 98.3×18 B3 | Outer Diameter 98.3 mm | In distribution |
| 75.5x40x22 C3 | Length 75.5 mm | In distribution |
| 98.3×18 A4 | Outer Diameter 98.3 mm | In distribution |
| 98.3×25 A1 | Outer Diameter 98.3 mm | In distribution |
| 24x24x24 B1 | Length 24 mm | In distribution |
| 98.3×25 A4 | Outer Diameter 98.3 mm | In distribution |
| 98.3×18 0M2 | Outer Diameter 98.3 mm | In distribution |
| 75.5x40x22 C1 | Length 75.5 mm | In distribution |
| 98.3×25 A3 | Outer Diameter 98.3 mm | In distribution |
| 98.3×38 D4 | Outer Diameter 98.3 mm | In distribution |
| 98.3×18 A3.5 | Outer Diameter 98.3 mm | In distribution |
| 98.3×18 C4 | Outer Diameter 98.3 mm | In distribution |
| 98.3×25 C2 | Outer Diameter 98.3 mm | In distribution |
| 98.3×18 B2 | Outer Diameter 98.3 mm | In distribution |
| 98.3×25 D4 | Outer Diameter 98.3 mm | In distribution |
| 75.5x40x22 C2 | Length 75.5 mm | In distribution |
| 24x24x24 A3 | Length 24 mm | In distribution |
| 98.3×38 C2 | Outer Diameter 98.3 mm | In distribution |
| 98.3×38 0M2 | Outer Diameter 98.3 mm | In distribution |
| 98.3×18 D2 | Outer Diameter 98.3 mm | In distribution |
| 98.3×25 D3 | Outer Diameter 98.3 mm | In distribution |
| 24x24x24 C2 | Length 24 mm | In distribution |
| 98.3×25 A2 | Outer Diameter 98.3 mm | In distribution |
| 75.5x40x22 B1 | Length 75.5 mm | In distribution |
| 98.3×18 0M3 | Outer Diameter 98.3 mm | In distribution |
| 24x24x24 B4 | Length 24 mm | In distribution |
| 98.3×18 A1 | Outer Diameter 98.3 mm | In distribution |
| 98.3×38 D3 | Outer Diameter 98.3 mm | In distribution |
| 98.3×38 A1 | Outer Diameter 98.3 mm | In distribution |
| 24x24x24 D3 | Length 24 mm | In distribution |
| 75.5x40x22 D2 | Length 75.5 mm | In distribution |
| 75.5x40x22 D4 | Length 75.5 mm | In distribution |
| 75.5x40x22 C4 | Length 75.5 mm | In distribution |
| 98.3×25 D2 | Outer Diameter 98.3 mm | In distribution |
| 75.5x40x22 0M2 | Length 75.5 mm | In distribution |
| 98.3×25 A3.5 | Outer Diameter 98.3 mm | In distribution |
| 98.3×38 B4 | Outer Diameter 98.3 mm | In distribution |
| 98.3×25 0M3 | Outer Diameter 98.3 mm | In distribution |
| 24x24x24 0M2 | Length 24 mm | In distribution |
| 98.3×38 C4 | Outer Diameter 98.3 mm | In distribution |
| 98.3×18 D4 | Outer Diameter 98.3 mm | In distribution |
| 98.3×38 B2 | Outer Diameter 98.3 mm | In distribution |
| 98.3×18 C1 | 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.