GC Initial™
GC Initial™ MC Classic Line Work Set 1, 8 paste opaque classic line (PO-CL A4, B1, B4, C1, C2, C4, D2, D4 - 4g, GC Initial IQ One ody Concept Fluo crystals (8g), 8 dentin (D-A4, B1, B4, C1,…
GC Initial™ MC Classic Line Work Set 1, 8 paste opaque classic line (PO-CL A4, B1, B4, C1, C2, C4, D2, D4 – 4g, GC Initial IQ One ody Concept Fluo crystals (8g), 8 dentin (D-A4, B1, B4, C1, C2, C4, D2, D4 20g), 2 bleach dentin BLD-1 light and BLD-3 Xwhite-20g, 8 opaque dentin (OD-A4, B1, B4, C1, C2, C4, D2 D4-20g, 2 Enamel E-57 & 60-20g, correction powder COR-20g, paste opaque thinner 8mL, modeling liquid 50mL
33manufacturers in China registered for this device type
2,724catalogue numbers in this listing
8510(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 | GC America Inc., United States |
|---|---|
| FDA product code | EIH |
| Device type | Powder, Porcelain |
| Device class | Class 2 |
| Regulation | 21 CFR 872.6660 |
| Establishment | Contract manufacturer, Remanufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K040567 |
| Record published | 2016-08-01 |
| Record revised | 2020-01-10 (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 |
| Storage | Storage environment temperature 39 to 77 °F; Storage environment temperature 4 to 25 °C |
| Packaging | Carton of 15 |
| Sizes | Weight 3 to 1000 g; total volume 8 to 1000 ml |
| Distribution end date | 2023-04-21 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 870083 | Weight 20 g | In distribution | |
| 870245 | Weight 20 g | In distribution | |
| 872545 | In distribution | ||
| 870002 | Weight 3 g | In distribution | |
| 012832 | In distribution | ||
| 870080 | In distribution | ||
| 870703 | In distribution | ||
| 874013 | Weight 20 g | In distribution | |
| 870587 | Weight 50 g | In distribution | |
| 870545 | In distribution | ||
| 870633 | In distribution | ||
| 875079 | In distribution | ||
| 877053 | In distribution | ||
| 872018 | In distribution | ||
| 870091 | Weight 20 g | In distribution | |
| 874151 | In distribution | ||
| 877072 | In distribution | ||
| 877052 | In distribution | ||
| 877069 | Weight 140 g | In distribution | |
| 872031 | In distribution | ||
| 872562 | In distribution | ||
| 875144 | Weight 20 g | In distribution | |
| 874002 | Weight 20 g | In distribution | |
| 871712 | In distribution | ||
| 872703 | In distribution | ||
| 876417 | Weight 4 g | In distribution | |
| 870121 | Weight 20 g | In distribution | |
| 870148 | In distribution | ||
| 875823 | Weight 20 g | In distribution | |
| 012840 | In distribution | ||
| 876480 | In distribution | ||
| 870072 | In distribution | ||
| 872727 | Weight 5 g | In distribution | |
| 874165 | In distribution | ||
| 875703 | Total Volume 25 ml | In distribution | |
| 877080 | Weight 21 g | In distribution | |
| 872008 | In distribution | ||
| 875123 | In distribution | ||
| 871138 | Weight 20 g | In distribution | |
| 730056 | Weight 1000 g | In distribution | |
| 870573 | Weight 50 g | In distribution | |
| 874101 | In distribution | ||
| 876578 | 5 | In distribution | |
| 870219 | Weight 4 g | In distribution | |
| 872009 | In distribution | ||
| 870137 | In distribution | ||
| 871142 | Weight 20 g | In distribution | |
| 871004 | Weight 20 g | In distribution | |
| 876557 | In distribution | ||
| 874067 | In distribution | ||
| 876506 | 5 | In distribution | |
| 876563 | 5 | In distribution | |
| 876564 | In distribution | ||
| 874713 | In distribution | ||
| 876525 | In distribution | ||
| 877075 | In distribution | ||
| 871038 | Weight 20 g | In distribution | |
| 876164 | In distribution | ||
| 875078 | In distribution | ||
| 870032 | Weight 20 g | In distribution | |
| 870041 | Weight 20 g | In distribution | |
| 875142 | In distribution | ||
| 870064 | Weight 20 g | In distribution | |
| 876403 | Weight 4 g | In distribution | |
| 876501 | 5 | In distribution | |
| 875102 | In distribution | ||
| 875862 | In distribution | ||
| 870061 | Weight 20 g | In distribution | |
| 875642 | Weight 50 g | In distribution | |
| 870648 | Weight 50 g | In distribution | |
| 875066 | In distribution | ||
| 871701 | In distribution | ||
| 870521 | Weight 50 g | In distribution | |
| 874142 | Weight 20 g | In distribution | |
| 872710 | Weight 10 g | In distribution | |
| 876579 | In distribution | ||
| 870570 | Weight 50 g | In distribution | |
| 732510 | Weight 200 g | In distribution | |
| 876575 | In distribution | ||
| 874139 | In distribution | ||
| 870506 | In distribution | ||
| 876552 | In distribution | ||
| 872527 | In distribution | ||
| 876407 | Weight 4 g | In distribution | |
| 872011 | In distribution | ||
| 871060 | Weight 20 g | In distribution | |
| 871075 | Weight 20 g | In distribution | |
| 875836 | In distribution | ||
| 870142 | In distribution | ||
| 871062 | In distribution | ||
| 870141 | Weight 20 g | In distribution | |
| 876502 | In distribution | ||
| 877070 | In distribution | ||
| 870180 | In distribution | ||
| 732740 | Weight 500 g | In distribution | |
| 875847 | Weight 20 g | In distribution | |
| 875604 | In distribution | ||
| 871065 | Weight 20 g | In distribution | |
| 877006 | Weight 880 g | In distribution | |
| 876574 | 5 | In distribution | |
| 871146 | Weight 20 g | In distribution | |
| 872506 | In distribution | ||
| 875647 | Weight 50 g | In distribution | |
| 870561 | Weight 50 g | In distribution | |
| 875635 | In distribution | ||
| 870004 | Weight 3 g | In distribution | |
| 870504 | In distribution | ||
| 871040 | In distribution | ||
| 870566 | In distribution | ||
| 871039 | In distribution | ||
| 876466 | In distribution | ||
| 870062 | Weight 20 g | In distribution | |
| 871058 | Weight 20 g | In distribution | |
| 870713 | Total Volume 50 ml | In distribution | |
| 730011 | Weight 300 g | In distribution | |
| 870803 | Weight 250 g | In distribution | |
| 875122 | Weight 20 g | In distribution | |
| 872033 | In distribution | ||
| 871087 | Weight 20 g | In distribution | |
| 875125 | Weight 20 g | In distribution | |
| 876533 | 5 | In distribution | |
| 876567 | In distribution | ||
| 870538 | Weight 50 g | In distribution | |
| 875581 | Weight 50 g | In distribution | |
| 872543 | Weight 5 g | In distribution | |
| 875644 | In distribution | ||
| 872526 | Weight 20 g | In distribution | |
| 876582 | In distribution | ||
| 012842 | In distribution | ||
| 870023 | Weight 3 g | In distribution | |
| 870518 | In distribution | ||
| 872706 | Weight 10 g | In distribution | |
| 870517 | In distribution | ||
| 870569 | In distribution | ||
| 870712 | Total Volume 50 ml | In distribution | |
| 870246 | In distribution | ||
| 870183 | Weight 20 g | In distribution | |
| 876560 | 5 | In distribution | |
| 870557 | Weight 50 g | In distribution | |
| 871009 | Weight 20 g | In distribution | |
| 871047 | Weight 20 g | In distribution | |
| 870563 | Weight 50 g | In distribution | |
| 870660 | In distribution | ||
| 871149 | In distribution | ||
| 872012 | In distribution | ||
| 870520 | In distribution | ||
| 870145 | In distribution | ||
| 875058 | In distribution | ||
| 876552 | 5 | In distribution | |
| 870638 | Weight 50 g | In distribution | |
| 876510 | 5 | In distribution | |
| 876423 | In distribution | ||
| 874001 | In distribution | ||
| 870042 | Weight 20 g | In distribution | |
| 872746 | In distribution | ||
| 870592 | In distribution | ||
| 875002 | Weight 20 g | In distribution | |
| 874712 | In distribution | ||
| 870079 | In distribution | ||
| 875572 | Weight 50 g | In distribution | |
| 874165 | Weight 20 g | In distribution | |
| 871149 | Weight 20 g | In distribution | |
| 875079 | Weight 20 g | In distribution | |
| 871103 | In distribution | ||
| 871017 | In distribution | ||
| 876419 | In distribution | ||
| 874058 | Weight 20 g | In distribution | |
| 872052 | In distribution | ||
| 871134 | Weight 20 g | In distribution | |
| 870130 | Weight 20 g | In distribution | |
| 872528 | Weight 20 g | In distribution | |
| 875146 | Weight 20 g | In distribution | |
| 870512 | In distribution | ||
| 874005 | In distribution | ||
| 875048 | Weight 20 g | In distribution | |
| 730059 | Weight 1000 g | In distribution | |
| 876513 | In distribution | ||
| 875561 | In distribution | ||
| 876493 | In distribution | ||
| 875123 | Weight 20 g | In distribution | |
| 732526 | Weight 500 g | In distribution | |
| 875847 | In distribution | ||
| 876220 | Total Volume 8 ml | In distribution | |
| 870173 | Weight 20 g | In distribution | |
| 871054 | In distribution | ||
| 870046 | Weight 20 g | In distribution | |
| 870003 | In distribution | ||
| 875859 | Weight 20 g | In distribution | |
| 870187 | In distribution | ||
| 872002 | In distribution | ||
| 010342 | In distribution | ||
| 870580 | Weight 50 g | In distribution | |
| 871053 | In distribution | ||
| 877010 | In distribution | ||
| 870818 | In distribution | ||
| 871711 | Total Volume 50 ml | In distribution | |
| 735052 | Weight 1000 g | In distribution | |
| 876577 | In distribution | ||
| 870538 | In distribution | ||
| 872509 | Weight 10 g | In distribution | |
| 874048 | Weight 20 g | In distribution | |
| 878114 | Weight 290 g | In distribution | |
| 876182 | Total Volume 8 ml | In distribution | |
| 874150 | In distribution | ||
| 874008 | Weight 20 g | In distribution | |
| 875603 | In distribution | ||
| 012834 | In distribution | ||
| 870604 | In distribution | ||
| 872740 | Weight 20 g | In distribution | |
| 874073 | Weight 20 g | In distribution | |
| 870702 | In distribution | ||
| 874141 | In distribution | ||
| 871021 | In distribution | ||
| 875585 | In distribution | ||
| 010327 | In distribution | ||
| 871051 | Weight 20 g | In distribution | |
| 875890 | In distribution | ||
| 870622 | Weight 50 g | In distribution | |
| 874146 | In distribution | ||
| 870819 | In distribution | ||
| 870135 | In distribution | ||
| 872770 | In distribution | ||
| 875586 | Weight 50 g | In distribution | |
| 874045 | Weight 20 g | In distribution | |
| 010340 | In distribution | ||
| 875633 | In distribution | ||
| 012845 | In distribution | ||
| 870179 | Weight 20 g | In distribution | |
| 870216 | Weight 4 g | In distribution | |
| 870077 | Weight 20 g | In distribution | |
| 874130 | In distribution | ||
| 872524 | In distribution | ||
| 876581 | 5 | In distribution | |
| 870213 | Weight 4 g | In distribution | |
| 872014 | In distribution | ||
| 876485 | In distribution | ||
| 876462 | In distribution | ||
| 875702 | In distribution | ||
| 875879 | In distribution | ||
| 875003 | In distribution | ||
| 877050 | Weight 8 g | In distribution | |
| 730068 | Weight 1000 g | In distribution | |
| 875132 | Weight 20 g | In distribution | |
| 875713 | Total Volume 50 ml | In distribution | |
| 874044 | In distribution | ||
| 871713 | In distribution | ||
| 874712 | Total Volume 50 ml | In distribution | |
| 870642 | In distribution | ||
| 872751 | Weight 3 g | In distribution | |
| 870202 | 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 |
| 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 |
| IPS e.max CAD | Ivoclar Vivadent Aktiengesellschaft | 1,045 |
Showing 12 of 10,017. All products under Powder, Porcelain
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K153130 | 2016-09-13 |
| K153136 | 2016-06-30 |
| K152274 | 2016-03-25 |
| K092020 | 2009-09-29 |
| K082740 | 2008-11-26 |
| K071674 | 2007-08-09 |
| K040567 | 2004-04-22 |
| K932039 | 1993-07-08 |
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.