DD Bio ZW Iso Color
65 catalogue numbers from 98H14 B1, listed by Dental Direkt GmbH, Germany, under Powder, Porcelain. 33 manufacturers in China are registered for this product code.
33manufacturers in China registered for this device type
65catalogue 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) | K142987 |
| Record published | 2024-08-27 |
| Record revised | 2025-12-11 (version 5) |
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 | Height 10 to 25 mm; outer diameter 98.5 mm |
| Distribution end date | 2025-12-10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 98H14 B1 | Height 14 mm | In distribution |
| 98H25 A1 | Height 25 mm | In distribution |
| 98H18 A2 | Height 18 mm | In distribution |
| 98H20 A3 | Height 25 mm | In distribution |
| 98H14 D2 | Height 14 mm | In distribution |
| 98H20 D2 | Height 20 mm | In distribution |
| 98H10 A3 | Height 10 mm | In distribution |
| 98H18 B1 | Height 18 mm | In distribution |
| 98H10 A1 | Outer Diameter 98.5 mm | In distribution |
| 98H18 A3.5 | Height 18 mm | In distribution |
| 98H20 A1 | Height 20 mm | In distribution |
| 98H10 C1 | Height 10 mm | In distribution |
| 98H10 A2 | Height 10 mm | In distribution |
| 98H14 B2 | Height 14 mm | In distribution |
| 98H10 B2 | Height 10 mm | In distribution |
| 98H25 B2 | Height 25 mm | In distribution |
| 98H10 A3.5 | Height 10 mm | In distribution |
| 98H18 C1 | Height 18 mm | In distribution |
| 98H14 A1 | Height 14 mm | In distribution |
| 98H18 D2 | Height 18 mm | In distribution |
| 98H10 D2 | Height 10 mm | In distribution |
| 98H20 A3.5 | Height 20 mm | In distribution |
| 98H20 A3 | Height 20 mm | In distribution |
| 98H25 D2 | Height 25 mm | In distribution |
| 98H20 C1 | Height 20 mm | In distribution |
| 98H25 A2 | Height 25 mm | In distribution |
| 98H25 C1 | Height 25 mm | In distribution |
| 98H14 C1 | Height 14 mm | In distribution |
| 98H18 B2 | Height 18 mm | In distribution |
| 98H20 B2 | Height 20 mm | In distribution |
| 98H25 B1 | Height 25 mm | In distribution |
| 98H14 A2 | Height 14 mm | In distribution |
| 98H18 A3 | Height 18 mm | In distribution |
| 98H14 A3.5 | Height 14 mm | In distribution |
| 98H20 A2 | Height 20 mm | In distribution |
| 98H18 A1 | Height 18 mm | In distribution |
| 98H25 A3.5 | Height 25 mm | In distribution |
| 98H20 B1 | Height 20 mm | In distribution |
| 98H14 A3 | Height 14 mm | In distribution |
| 98H10 B1 | Height 10 mm | In distribution |
| 98H10 1000 | Outer Diameter 98.5 mm | Withdrawn |
| 98H20 500 | Outer Diameter 98.5 mm | Withdrawn |
| 98H14 1000 | Outer Diameter 98.5 mm | Withdrawn |
| 98H18 500 | Outer Diameter 98.5 mm | Withdrawn |
| 98H18 2000 | Withdrawn | |
| 98H14 800 | Outer Diameter 98.5 mm | Withdrawn |
| 98H18 1000 | Outer Diameter 98.5 mm | Withdrawn |
| 98H20 2000 | Outer Diameter 98.5 mm | Withdrawn |
| 98H20 1333 | Height 20 mm | Withdrawn |
| 98H14 1333 | Outer Diameter 98.5 mm | Withdrawn |
| 98H20 800 | Outer Diameter 98.5 mm | Withdrawn |
| 98H25 500 | Outer Diameter 98.5 mm | Withdrawn |
| 98H10 800 | Outer Diameter 98.5 mm | Withdrawn |
| 98H10 1333 | Outer Diameter 98.5 mm | Withdrawn |
| 98H25 800 | Outer Diameter 98.5 mm | Withdrawn |
| 98H14 500 | Height 14 mm | Withdrawn |
| 98H18 1333 | Outer Diameter 98.5 mm | Withdrawn |
| 98H25 1000 | Outer Diameter 98.5 mm | Withdrawn |
| 98H10 2000 | Outer Diameter 98.5 mm | Withdrawn |
| 98H10 500 | Outer Diameter 98.5 mm | Withdrawn |
| 98H25 2000 | Outer Diameter 98.5 mm | Withdrawn |
| 98H20 1000 | Outer Diameter 98.5 mm | Withdrawn |
| 98H25 1333 | Outer Diameter 98.5 mm | Withdrawn |
| 98H14 2000 | Outer Diameter 98.5 mm | Withdrawn |
| 98H18 800 | Outer Diameter 98.5 mm | Withdrawn |
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.