OPC Plus
3 catalogue numbers from 650845, listed by Ivoclar Vivadent, Inc., Canada, under Powder, Porcelain. 33 manufacturers in China are registered for this product code.
33manufacturers in China registered for this device type
3catalogue numbers in this listing
9510(k) clearances naming this product code
32recalls on this 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 | Ivoclar Vivadent, Inc., Canada |
|---|---|
| FDA product code | EIH |
| Device type | Powder, Porcelain |
| Device class | Class 2 |
| Regulation | 21 CFR 872.6660 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2017-01-27 |
| Record revised | 2021-06-23 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2021-06-22 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 650845 | Withdrawn | |
| 650847 | Withdrawn | |
| 650846 | 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 |
|---|---|
| K253953 | 2026-03-10 |
| K211916 | 2021-08-20 |
| K152103 | 2016-05-20 |
| K151894 | 2015-10-29 |
| K121359 | 2012-07-27 |
| K120134 | 2012-06-25 |
| K103556 | 2011-04-13 |
| K071848 | 2007-08-30 |
| K051705 | 2005-10-14 |
Recalls
32 of these are 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 | Closed |
|---|---|---|---|---|---|
| 2024-04-05 | Class II | Under Investigation by firm | Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient’s mouth and require restoration | 12525 units | |
| 2024-04-05 | Class II | Under Investigation by firm | Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient’s mouth and require restoration | 7445 units | |
| 2024-04-05 | Class II | Under Investigation by firm | Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient’s mouth and require restoration | 2472 units | |
| 2024-04-05 | Class II | Under Investigation by firm | Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient’s mouth and require restoration | 11330 units | |
| 2024-04-05 | Class II | Under Investigation by firm | Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient’s mouth and require restoration | 2286 units | |
| 2024-04-05 | Class II | Under Investigation by firm | Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient’s mouth and require restoration | 4080 units | |
| 2020-04-13 | Class II | Process control | Restorations crack during the sintering process. | 332 | 2021-01-22 |
| 2020-04-13 | Class II | Process control | Restorations crack during the sintering process. | 6 units | 2021-01-22 |
| 2020-04-13 | Class II | Process control | Restorations crack during the sintering process. | 639 units | 2021-01-22 |
| 2020-04-13 | Class II | Process control | Restorations crack during the sintering process. | 9 units | 2021-01-22 |
| 2016-05-27 | Class II | Process design | The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation. | 94 units | 2018-06-14 |
| 2016-05-27 | Class II | Process design | The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation. | 18 units | 2018-06-14 |
| 2016-05-27 | Class II | Process design | The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation. | 19 units | 2018-06-14 |
| 2016-05-27 | Class II | Process design | The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation. | 17 units | 2018-06-14 |
| 2016-05-27 | Class II | Process design | The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation. | 43 units | 2018-06-14 |
| 2016-05-27 | Class II | Process design | The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation. | 11 units | 2018-06-14 |
| 2016-05-27 | Class II | Process design | The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation. | 60 units | 2018-06-14 |
| 2016-05-27 | Class II | Process design | The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation. | 37 units | 2018-06-14 |
| 2016-05-27 | Class II | Process design | The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation. | 25 units | 2018-06-14 |
| 2016-05-27 | Class II | Process design | The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation. | 5 units | 2018-06-14 |
| 2016-05-27 | Class II | Process design | The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation. | 9 units | 2018-06-14 |
| 2016-05-27 | Class II | Process design | The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation. | 42 units | 2018-06-14 |
| 2016-05-27 | Class II | Process design | The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation. | 72 units | 2018-06-14 |
| 2016-05-27 | Class II | Process design | The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation. | 40 units | 2018-06-14 |
| 2016-05-27 | Class II | Process design | The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation. | 11 units | 2018-06-14 |
| 2016-05-27 | Class II | Process design | The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation. | 13 units | 2018-06-14 |
| 2016-05-27 | Class II | Process design | The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation. | 27 units | 2018-06-14 |
| 2016-05-27 | Class II | Process design | The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation. | 15 units | 2018-06-14 |
| 2016-05-27 | Class II | Process design | The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation. | 7 units | 2018-06-14 |
| 2016-05-27 | Class II | Process design | The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation. | 10 units | 2018-06-14 |
| 2016-05-27 | Class II | Process design | The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation. | 79 units | 2018-06-14 |
| 2015-07-09 | Class II | Nonconforming Material/Component | Complaints were received of coarse particles in the glazed surface of IPS e.max Ceram restorations. A basic component of the glass contains a higher number of large grain sizes than usual. | Domestic: 27 units | 2016-05-27 |
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.