Henry Schein
Starter Kit that includes, 1 A1 14mm, 1 A2 14mm, 1 C3 14mm, 1 D2 14mm, 1 Set of 4 Calibration Rings, 1 Set of 4 Crown Samples A1, A2, C3, D2, IFU
33manufacturers in China registered for this device type
836catalogue numbers in this listing
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 | Henry Schein, Inc., United States |
|---|---|
| FDA product code | EIH |
| Device type | Powder, Porcelain |
| Device class | Class 2 |
| Regulation | 21 CFR 872.6660 |
| Record published | 2016-09-24 |
| Record revised | 2019-11-04 (version 5) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature 0 to 30 °C; Special storage condition: Dry storage space |
| Sizes | Outer diameter 89 to 100 mm; length 14 to 85 mm; total volume 20 to 940 ml |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 9011594 | Outer Diameter 100 mm | In distribution | |
| 9011047 | Outer Diameter 98.5 mm | In distribution | |
| 9011936 | Outer Diameter 95 mm | In distribution | |
| 9011790 | Outer Diameter 95 mm | In distribution | |
| 9011684 | Outer Diameter 95 mm | In distribution | |
| 1126980 | 2 | In distribution | |
| 9011457 | Outer Diameter 100 mm | In distribution | |
| 9011232 | Length 65 mm | In distribution | |
| 9009713 | Length 14 mm | In distribution | |
| 9011617 | Total Volume 50 ml | In distribution | |
| 9011036 | Outer Diameter 98.5 mm | In distribution | |
| 9011415 | Outer Diameter 98.5 mm | In distribution | |
| 9011603 | Total Volume 50 ml | In distribution | |
| 9011209 | Length 55 mm | In distribution | |
| 9012148 | Outer Diameter 89 mm | In distribution | |
| 9011779 | Outer Diameter 95 mm | In distribution | |
| 9011430 | Outer Diameter 100 mm | In distribution | |
| 9011533 | Outer Diameter 100 mm | In distribution | |
| 9011605 | Total Volume 50 ml | In distribution | |
| 9011187 | Length 40 mm | In distribution | |
| 9012186 | Length 20 mm | In distribution | |
| 9011509 | Outer Diameter 100 mm | In distribution | |
| 9011455 | Outer Diameter 100 mm | In distribution | |
| 9011650 | Length 65 mm | In distribution | |
| 9011838 | Outer Diameter 95 mm | In distribution | |
| 9011832 | Outer Diameter 95 mm | In distribution | |
| 9011410 | Outer Diameter 98.5 mm | In distribution | |
| 9011732 | Outer Diameter 95 mm | In distribution | |
| 9011234 | Length 65 mm | In distribution | |
| 9011980 | Outer Diameter 89 mm | In distribution | |
| 9011435 | Outer Diameter 100 mm | In distribution | |
| 9011223 | Length 65 mm | In distribution | |
| 9012173 | Outer Diameter 98.5 mm | In distribution | |
| 9011019 | Outer Diameter 98.5 mm | In distribution | |
| 9011782 | Outer Diameter 95 mm | In distribution | |
| 9011573 | Outer Diameter 100 mm | In distribution | |
| 9011746 | Outer Diameter 95 mm | In distribution | |
| 9011039 | Outer Diameter 98.5 mm | In distribution | |
| 9011518 | Outer Diameter 100 mm | In distribution | |
| 9011822 | Outer Diameter 95 mm | In distribution | |
| 9011164 | Outer Diameter 98.5 mm | In distribution | |
| 9011056 | Outer Diameter 98.5 mm | In distribution | |
| 9011669 | Outer Diameter 100 mm | In distribution | |
| 9012156 | Outer Diameter 89 mm | In distribution | |
| 9011731 | Outer Diameter 95 mm | In distribution | |
| 9012089 | Outer Diameter 89 mm | In distribution | |
| 9011658 | Outer Diameter 100 mm | In distribution | |
| 9012044 | Outer Diameter 89 mm | In distribution | |
| 9011416 | Outer Diameter 98.5 mm | In distribution | |
| 9011763 | Outer Diameter 95 mm | In distribution | |
| 9012097 | Outer Diameter 89 mm | In distribution | |
| 5703402 | In distribution | ||
| 9011241 | Length 85 mm | In distribution | |
| 9011819 | Outer Diameter 95 mm | In distribution | |
| 9011659 | Outer Diameter 100 mm | In distribution | |
| 9011700 | Outer Diameter 95 mm | In distribution | |
| 9012112 | Outer Diameter 89 mm | In distribution | |
| 9011066 | Outer Diameter 98.5 mm | In distribution | |
| 9011507 | Outer Diameter 100 mm | In distribution | |
| 9011656 | Outer Diameter 100 mm | In distribution | |
| 9011702 | Outer Diameter 95 mm | In distribution | |
| 9011820 | Outer Diameter 95 mm | In distribution | |
| 9011400 | Outer Diameter 98.5 mm | In distribution | |
| 9011414 | Outer Diameter 98.5 mm | In distribution | |
| 9011199 | Length 40 mm | In distribution | |
| 9011235 | Length 65 mm | In distribution | |
| 9009712 | Outer Diameter 95 mm | In distribution | |
| 9012050 | Outer Diameter 89 mm | In distribution | |
| 9011406 | Outer Diameter 98.5 mm | In distribution | |
| 9011719 | Outer Diameter 95 mm | In distribution | |
| 9011736 | Outer Diameter 95 mm | In distribution | |
| 9011765 | Outer Diameter 95 mm | In distribution | |
| 9011489 | Outer Diameter 100 mm | In distribution | |
| 9012204 | Length 20 mm | In distribution | |
| 9011625 | Outer Diameter 98.5 mm | In distribution | |
| 9011799 | Outer Diameter 95 mm | In distribution | |
| 9011133 | Outer Diameter 98.5 mm | In distribution | |
| 9011721 | Outer Diameter 95 mm | In distribution | |
| 9011424 | Length 65 mm | In distribution | |
| 9009710 | Outer Diameter 95 mm | In distribution | |
| 9012179 | Outer Diameter 98.5 mm | In distribution | |
| 9011170 | Outer Diameter 98.5 mm | In distribution | |
| 9011739 | Outer Diameter 95 mm | In distribution | |
| 9011972 | Outer Diameter 89 mm | In distribution | |
| 9011487 | Outer Diameter 100 mm | In distribution | |
| 9009721 | Length 65 mm | In distribution | |
| 9011492 | Outer Diameter 100 mm | In distribution | |
| 9012026 | Outer Diameter 89 mm | In distribution | |
| 9012065 | Outer Diameter 89 mm | In distribution | |
| 9012166 | Outer Diameter 98.5 mm | In distribution | |
| 9011166 | Outer Diameter 98.5 mm | In distribution | |
| 9012055 | Outer Diameter 89 mm | In distribution | |
| 9012208 | Length 20 mm | In distribution | |
| 9012045 | Outer Diameter 89 mm | In distribution | |
| 9011638 | Outer Diameter 98.5 mm | In distribution | |
| 9011225 | Length 65 mm | In distribution | |
| 9011784 | Outer Diameter 95 mm | In distribution | |
| 9011472 | Outer Diameter 100 mm | In distribution | |
| 9009723 | Outer Diameter 89 mm | In distribution | |
| 9011116 | Outer Diameter 98.5 mm | In distribution | |
| 9012074 | Outer Diameter 89 mm | In distribution | |
| 9012086 | Outer Diameter 89 mm | In distribution | |
| 9011602 | Total Volume 50 ml | In distribution | |
| 9011695 | Outer Diameter 95 mm | In distribution | |
| 9009705 | Outer Diameter 95 mm | In distribution | |
| 9011590 | Outer Diameter 100 mm | In distribution | |
| 9011663 | Outer Diameter 100 mm | In distribution | |
| 9011021 | Outer Diameter 98.5 mm | In distribution | |
| 9011956 | Outer Diameter 95 mm | In distribution | |
| 9011464 | Outer Diameter 100 mm | In distribution | |
| 9012206 | Length 20 mm | In distribution | |
| 9011698 | Outer Diameter 95 mm | In distribution | |
| 9009699 | Outer Diameter 98.5 mm | In distribution | |
| 9011789 | Outer Diameter 95 mm | In distribution | |
| 9011405 | Outer Diameter 98.5 mm | In distribution | |
| 9011213 | Length 55 mm | In distribution | |
| 9011933 | Outer Diameter 95 mm | In distribution | |
| 9012193 | Length 20 mm | In distribution | |
| 9011493 | Outer Diameter 100 mm | In distribution | |
| 9011992 | Outer Diameter 89 mm | In distribution | |
| 9011089 | Outer Diameter 98.5 mm | In distribution | |
| 9011469 | Outer Diameter 100 mm | In distribution | |
| 9011504 | Outer Diameter 100 mm | In distribution | |
| 9011837 | Outer Diameter 95 mm | In distribution | |
| 9011470 | Outer Diameter 100 mm | In distribution | |
| 9011691 | Outer Diameter 95 mm | In distribution | |
| 9011796 | Outer Diameter 95 mm | In distribution | |
| 9012080 | Outer Diameter 89 mm | In distribution | |
| 9012151 | Outer Diameter 89 mm | In distribution | |
| 9011411 | Outer Diameter 98.5 mm | In distribution | |
| 9011418 | Length 40 mm | In distribution | |
| 9011063 | Outer Diameter 98.5 mm | In distribution | |
| 9011517 | Outer Diameter 100 mm | In distribution | |
| 9011793 | Outer Diameter 95 mm | In distribution | |
| 9012083 | Outer Diameter 89 mm | In distribution | |
| 9011449 | Outer Diameter 100 mm | In distribution | |
| 9012022 | Outer Diameter 89 mm | In distribution | |
| 9011153 | Outer Diameter 98.5 mm | In distribution | |
| 9011806 | Outer Diameter 95 mm | In distribution | |
| 9012187 | Length 20 mm | In distribution | |
| 9011130 | Outer Diameter 98.5 mm | In distribution | |
| 9011120 | Outer Diameter 98.5 mm | In distribution | |
| 9011961 | Outer Diameter 95 mm | In distribution | |
| 9011811 | Outer Diameter 95 mm | In distribution | |
| 9009698 | Outer Diameter 98.5 mm | In distribution | |
| 9011745 | Outer Diameter 95 mm | In distribution | |
| 9011758 | Outer Diameter 95 mm | In distribution | |
| 9011505 | Outer Diameter 100 mm | In distribution | |
| 9011964 | Outer Diameter 89 mm | In distribution | |
| 9011053 | Outer Diameter 98.5 mm | In distribution | |
| 9011581 | Outer Diameter 100 mm | In distribution | |
| 9011483 | Outer Diameter 100 mm | In distribution | |
| 9012068 | Outer Diameter 89 mm | In distribution | |
| 9011817 | Outer Diameter 95 mm | In distribution | |
| 9011182 | Outer Diameter 98.5 mm | In distribution | |
| 9011652 | Length 85 mm | In distribution | |
| 9011086 | Outer Diameter 98.5 mm | In distribution | |
| 9011482 | Outer Diameter 100 mm | In distribution | |
| 9011511 | Outer Diameter 100 mm | In distribution | |
| 9011591 | Outer Diameter 100 mm | In distribution | |
| 9011181 | Outer Diameter 98.5 mm | In distribution | |
| 9012171 | Outer Diameter 98.5 mm | In distribution | |
| 9011183 | Outer Diameter 98.5 mm | In distribution | |
| 9011743 | Outer Diameter 95 mm | In distribution | |
| 9012174 | Outer Diameter 98.5 mm | In distribution | |
| 9011525 | Outer Diameter 100 mm | In distribution | |
| 9011134 | Outer Diameter 98.5 mm | In distribution | |
| 9009725 | Outer Diameter 89 mm | In distribution | |
| 9011693 | Outer Diameter 95 mm | In distribution | |
| 9011720 | Outer Diameter 95 mm | In distribution | |
| 9011629 | Outer Diameter 98.5 mm | In distribution | |
| 9011976 | Outer Diameter 89 mm | In distribution | |
| 9011686 | Outer Diameter 95 mm | In distribution | |
| 9012137 | Outer Diameter 89 mm | In distribution | |
| 9011595 | Outer Diameter 100 mm | In distribution | |
| 9011644 | Outer Diameter 98.5 mm | In distribution | |
| 9011173 | Outer Diameter 98.5 mm | In distribution | |
| 9011610 | Total Volume 50 ml | In distribution | |
| 9011054 | Outer Diameter 98.5 mm | In distribution | |
| 9012180 | Outer Diameter 98.5 mm | In distribution | |
| 9011821 | Outer Diameter 95 mm | In distribution | |
| 9011701 | Outer Diameter 95 mm | In distribution | |
| 9011154 | Outer Diameter 98.5 mm | In distribution | |
| 9012094 | Outer Diameter 89 mm | In distribution | |
| 9011402 | Outer Diameter 98.5 mm | In distribution | |
| 9012104 | Outer Diameter 89 mm | In distribution | |
| 9011046 | Outer Diameter 98.5 mm | In distribution | |
| 9012099 | Outer Diameter 89 mm | In distribution | |
| 9009720 | Length 65 mm | In distribution | |
| 9012123 | Outer Diameter 89 mm | In distribution | |
| 9011653 | Length 85 mm | In distribution | |
| 9011827 | Outer Diameter 95 mm | In distribution | |
| 9011687 | Outer Diameter 95 mm | In distribution | |
| 9011461 | Outer Diameter 100 mm | In distribution | |
| 9011689 | Outer Diameter 95 mm | In distribution | |
| 9011064 | Outer Diameter 98.5 mm | In distribution | |
| 9012134 | Outer Diameter 89 mm | In distribution | |
| 9011194 | Length 40 mm | In distribution | |
| 9011734 | Outer Diameter 95 mm | In distribution | |
| 9011934 | Outer Diameter 95 mm | In distribution | |
| 9011121 | Outer Diameter 98.5 mm | In distribution | |
| 9011754 | Outer Diameter 95 mm | In distribution | |
| 9011127 | Outer Diameter 98.5 mm | In distribution | |
| 9011953 | Outer Diameter 95 mm | In distribution | |
| 9011859 | Outer Diameter 95 mm | In distribution | |
| 9011682 | Outer Diameter 95 mm | In distribution | |
| 9012027 | Outer Diameter 89 mm | In distribution | |
| 9011417 | Length 40 mm | In distribution | |
| 9011230 | Length 65 mm | In distribution | |
| 9011975 | Outer Diameter 89 mm | In distribution | |
| 9011683 | Outer Diameter 95 mm | In distribution | |
| 9011024 | Outer Diameter 98.5 mm | In distribution | |
| 9011463 | Outer Diameter 100 mm | In distribution | |
| 9011026 | Outer Diameter 98.5 mm | In distribution | |
| 9011645 | Length 40 mm | In distribution | |
| 9011997 | Outer Diameter 89 mm | In distribution | |
| 9011191 | Length 40 mm | In distribution | |
| 9012033 | Outer Diameter 89 mm | In distribution | |
| 9011020 | Outer Diameter 98.5 mm | In distribution | |
| 9011804 | Outer Diameter 95 mm | In distribution | |
| 9011946 | Outer Diameter 95 mm | In distribution | |
| 9011473 | Outer Diameter 100 mm | In distribution | |
| 9011755 | Outer Diameter 95 mm | In distribution | |
| 9011198 | Length 40 mm | In distribution | |
| 9011480 | Outer Diameter 100 mm | In distribution | |
| 9011520 | Outer Diameter 100 mm | In distribution | |
| 9011407 | Outer Diameter 98.5 mm | In distribution | |
| 9011062 | Outer Diameter 98.5 mm | In distribution | |
| 9012120 | Outer Diameter 89 mm | In distribution | |
| 9011200 | Length 40 mm | In distribution | |
| 9011506 | Outer Diameter 100 mm | In distribution | |
| 9011082 | Outer Diameter 98.5 mm | In distribution | |
| 9011179 | Outer Diameter 98.5 mm | In distribution | |
| 9012069 | Outer Diameter 89 mm | In distribution | |
| 9012010 | Outer Diameter 89 mm | In distribution | |
| 9011150 | Outer Diameter 98.5 mm | In distribution | |
| 9011447 | Outer Diameter 100 mm | In distribution | |
| 9011192 | Length 40 mm | In distribution | |
| 9011159 | Outer Diameter 98.5 mm | In distribution | |
| 9012002 | Outer Diameter 89 mm | In distribution | |
| 9011762 | Outer Diameter 95 mm | In distribution | |
| 9011767 | Outer Diameter 95 mm | In distribution | |
| 9011111 | Outer Diameter 98.5 mm | In distribution | |
| 9012049 | Outer Diameter 89 mm | In distribution | |
| 9012059 | Outer Diameter 89 mm | In distribution | |
| 9011421 | Length 55 mm | In distribution | |
| 9011158 | Outer Diameter 98.5 mm | In distribution | |
| 9011582 | Outer Diameter 100 mm | In distribution | |
| 9012018 | Outer Diameter 89 mm | In distribution | |
| 9012125 | Outer Diameter 89 mm | In distribution |
Showing 250 of 300 catalogue numbers.
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
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.