Zolid-SHT
96 catalogue numbers from ZOLID-SHT multilayer 0/B1 98x20mm, listed by Amann Girrbach AG, Austria, under Powder, Porcelain. 33 manufacturers in China are registered for this product code.
33manufacturers in China registered for this device type
96catalogue 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 | Amann Girrbach AG, Austria |
|---|---|
| FDA product code | EIH |
| Device type | Powder, Porcelain |
| Device class | Class 2 |
| Regulation | 21 CFR 872.6660 |
| Establishment | Private-label distributor, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K152383 |
| Record published | 2017-11-17 |
| Record revised | 2024-09-06 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Distribution end date | 2023-01-31 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ZOLID-SHT multilayer 0/B1 98x20mm | In distribution | |
| ZOLID-SHT multilayer A2/A3 98x14mm | In distribution | |
| ZOLID-SHT multilayer B2/B3 14mm | In distribution | |
| ZOLID-SHT multilayer B2/B3 98x16mm | In distribution | |
| ZOLID-SHT preshade A medium 14mm | Withdrawn | |
| ZOLID-SHT multilayer A2/A3 14mm | Withdrawn | |
| ZOLID-SHT multilayer C1/C2 20mm | Withdrawn | |
| ZOLID-SHT preshade bleach 98x16mm | Withdrawn | |
| ZOLID-SHT multilayer 0/A1 98x20mm | Withdrawn | |
| ZOLID-SHT multilayer 0/A1 98x16mm | Withdrawn | |
| ZOLID-SHT multilayer C1/C2 98x16mm | Withdrawn | |
| ZOLID-SHT multilayer D37D4 98x20mm | Withdrawn | |
| ZOLID-SHT preshade B light 20mm | Withdrawn | |
| ZOLID-SHT preshade C light 14mm | Withdrawn | |
| ZOLID-SHT multilayer D2/D3 14mm | Withdrawn | |
| ZOLID-SHT multilayer D2/D3 16mm | Withdrawn | |
| ZOLID-SHT multilayer C3/C4 98x14mm | Withdrawn | |
| ZOLID-SHT preshade A medium 98x16mm | Withdrawn | |
| ZOLID-SHT multilayer 0/A1 20mm | Withdrawn | |
| ZOLID-SHT multilayer C3/C4 98x16mm | Withdrawn | |
| ZOLID-SHT preshade D light 98x16mm | Withdrawn | |
| ZOLID-SHT multilayer C3/C4 16mm | Withdrawn | |
| ZOLID-SHT multilayer B3/B4 98x16mm | Withdrawn | |
| ZOLID-SHT preshade A light 98x20mm | Withdrawn | |
| ZOLID-SHT multilayer A2/A3 16mm | Withdrawn | |
| ZOLID-SHT multilayer C1/C2 14mm | Withdrawn | |
| ZOLID-SHT preshade C light 98x16mm | Withdrawn | |
| ZOLID-SHT multilayer B2/B3 20mm | Withdrawn | |
| ZOLID-SHT multilayer 0/A1 16mm | Withdrawn | |
| ZOLID-SHT preshade A medium 20mm | Withdrawn | |
| ZOLID-SHT multilayer B2/B3 98x14mm | Withdrawn | |
| ZOLID-SHT preshade bleach 98×14 | Withdrawn | |
| ZOLID-SHT multilayer 0/A1 98x14mm | Withdrawn | |
| ZOLID-SHT preshade D light 16mm | Withdrawn | |
| ZOLID-SHT multilayer D2/D3 98x14mm | Withdrawn | |
| ZOLID-SHT preshade B light 14mm | Withdrawn | |
| ZOLID-SHT preshade bleach 98x20mm | Withdrawn | |
| ZOLID-SHT multilayer D3/D4 98x14mm | Withdrawn | |
| ZOLID-SHT multilayer A2/A3 20mm | Withdrawn | |
| ZOLID-SHT multilayer A2/A3 98x16mm | Withdrawn | |
| ZOLID-SHT preshade A light 20mm | Withdrawn | |
| ZOLID-SHT multilayer B3/B4 16mm | Withdrawn | |
| ZOLID-SHT multilayer A3,5/A4 98x20mm | Withdrawn | |
| ZOLID-SHT preshade C light 98x14mm | Withdrawn | |
| ZOLID-SHT multilayer A3,5/A4 98x14mm | Withdrawn | |
| ZOLID-SHT preshade A light 14mm | Withdrawn | |
| ZOLID-SHT preshade A medium 98x20mm | Withdrawn | |
| ZOLID-SHT multilayer C3/C4 98x20mm | Withdrawn | |
| ZOLID-SHT multilayer D3/D4 20mm | Withdrawn | |
| ZOLID-SHT multilayer 0/B1 14mm | Withdrawn | |
| ZOLID-SHT preshade B light 98x16mm | Withdrawn | |
| ZOLID-SHT multilayer A3,57A4 98x16mm | Withdrawn | |
| ZOLID-SHT multilayer B2/B3 16mm | Withdrawn | |
| ZOLID-SHT preshade C light 20mm | Withdrawn | |
| ZOLID-SHT multilayer B3/B4 20mm | Withdrawn | |
| ZOLID-SHT multilayer C3/C4 14mm | Withdrawn | |
| ZOLID-SHT multilayer B3/B4 98x14mm | Withdrawn | |
| ZOLID-SHT preshade B light 98x14mm | Withdrawn | |
| ZOLID-SHT multilayer D2/D3 98x16mm | Withdrawn | |
| ZOLID-SHT preshade D light 98x20mm | Withdrawn | |
| ZOLID-SHT multilayer C17C2 98x14mm | Withdrawn | |
| ZOLID-SHT preshade bleach 20mm | Withdrawn | |
| ZOLID-SHT preshade A light 98x16mm | Withdrawn | |
| ZOLID-SHT multilayer 0/B1 16mm | Withdrawn | |
| ZOLID-SHT preshade bleach 16mm | Withdrawn | |
| ZOLID-SHT multilayer C1/C2 98x20mm | Withdrawn | |
| ZOLID-SHT multilayer D27D3 20mm | Withdrawn | |
| ZOLID-SHT multilayer D3/D4 98x16mm | Withdrawn | |
| ZOLID-SHT preshade C light 16mm | Withdrawn | |
| ZOLID-SHT preshade C light 98x20mm | Withdrawn | |
| ZOLID-SHT multilayer 0/B1 98×14 | Withdrawn | |
| ZOLID-SHT multilayer A3,5/A4 20mm | Withdrawn | |
| ZOLID-SHT preshade A light 16mm | Withdrawn | |
| ZOLID-SHT preshade D light 14mm | Withdrawn | |
| ZOLID-SHT multilayer C3/C4 20mm | Withdrawn | |
| ZOLID-SHT preshade A medium 98x14mm | Withdrawn | |
| ZOLID-SHT multilayer 0/B1 98x16mm | Withdrawn | |
| ZOLID-SHT multilayer D37D4 16mm | Withdrawn | |
| ZOLID-SHT preshade D light 20mm | Withdrawn | |
| ZOLID-SHT multilayer B3/B4 98x20mm | Withdrawn | |
| ZOLID-SHT multilayer B3/B4 14mm | Withdrawn | |
| ZOLID-SHT multilayer D2/D3 98x20mm | Withdrawn | |
| ZOLID-SHT preshade bleach 14mm | Withdrawn | |
| ZOLID-SHT multilayer A3,5/A4 16mm | Withdrawn | |
| ZOLID-SHT multilayer 0/B1 20mm | Withdrawn | |
| ZOLID-SHT preshade A medium 16mm | Withdrawn | |
| ZOLID-SHT multilayer A2/A3 98x20mm | Withdrawn | |
| ZOLID-SHT multilayer D3/D4 14mm | Withdrawn | |
| ZOLID-SHT multilayer A3,5/A4 14mm | Withdrawn | |
| ZOLID-SHT preshade D light 98x14mm | Withdrawn | |
| ZOLID-SHT preshade B light 16mm | Withdrawn | |
| ZOLID-SHT multilayer C1/C2 16mm | Withdrawn | |
| ZOLID-SHT multilayer B2/B3 98x20mm | Withdrawn | |
| ZOLID-SHT preshade A light 98x14mm | Withdrawn | |
| ZOLID-SHT preshade B light 98x20mm | Withdrawn | |
| ZOLID-SHT multilayer 0/A1 14mm | 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 |
|---|---|
| K260918 | 2026-06-29 |
| K171876 | 2017-09-20 |
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.