MiYO Esthetic System
90 catalogue numbers from MiYO Esthetic System Glidewell.io Kit, listed by Jensen Industries, Inc., United States, under Powder, Porcelain. 33 manufacturers in China are registered for this product code.
33manufacturers in China registered for this device type
90catalogue numbers in this listing
11510(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 | Jensen Industries, Inc., United States |
|---|---|
| FDA product code | EIH |
| Device type | Powder, Porcelain |
| Device class | Class 2 |
| Regulation | 21 CFR 872.6660 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K111743 |
| Record published | 2023-02-27 |
| Record revised | 2020-01-14 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MiYO Esthetic System Glidewell.io Kit | In distribution | |
| MiYO Hi Fusing Gingival Structure Rouge Paste 4g | In distribution | |
| MiYO Trans Cobalt Fluor paste 4g | In distribution | |
| MiYO Gingival Salmon Paste 4g | In distribution | |
| MiYO Trans Lumin Plus Fluor paste 4g | In distribution | |
| MiYO Mamelon Pumpkin Fluor paste 4g | In distribution | |
| MiYO Gingival Crimson Paste 4g | In distribution | |
| MiYO 850 Trans Smoke Fluor Paste 4g | In distribution | |
| MiYO Mamelon Coral Fluor paste 4g | In distribution | |
| MiYO 3D Trans Shade 5 Fluor Paste 4g | In distribution | |
| MiYO Gingival Structure Frost paste 4g | In distribution | |
| MiYO Trans Slate Fluor paste 4g | In distribution | |
| MiYO 850 Halo Spring Fluor Paste 4g | In distribution | |
| MiYO 3D Esthetic System Essential Kit | In distribution | |
| MiYO Trans Shade B Fluor paste 4g | In distribution | |
| MiYO 850 Spray Glaze 100g | In distribution | |
| MiYO Structure Window Flour paste 4g | In distribution | |
| MiYO 850 Spray Glaze 40g | In distribution | |
| MiYO Gingival Sable Paste 4g | In distribution | |
| MiYO Trans Garnet Paste 4g | In distribution | |
| MiYO 3D Trans Shade 3 Fluor Paste 4g | In distribution | |
| MiYO Halo Autumn Fluor paste 4g | In distribution | |
| MiYO Gingival Trans Raspberry Paste 4g | In distribution | |
| MiYO Trans Storm Fluor paste 4g | In distribution | |
| MiYO Trans Sage Fluor paste 4g | In distribution | |
| MiYO Gingival Structure Orchid paste 4g | In distribution | |
| MiYO 850 Glaze Liquid 25ml | In distribution | |
| MiYO Gingival Carnation Paste 4g | In distribution | |
| MiYO 850 Trans Sage Fluor Paste 4g | In distribution | |
| MiYO Trans Lotus Fluor paste 4g | In distribution | |
| MiYO Fissure Flour powder 4g | In distribution | |
| MiYO Mamelon Wheat Fluor paste 4g | In distribution | |
| MiYO High Performance Glaze Paste 6g | In distribution | |
| MiYO 850 Trans Shade D Fluor Paste 4g | In distribution | |
| MiYO 3D Trans Shade 2 Fluor Paste 4g | In distribution | |
| MiYO Trans Sunflower Fluor Paste 4g | In distribution | |
| MiYO 3D Trans Shade 9 Fluor Paste 4g | In distribution | |
| MiYO Gingival Hibiscus Paste 4g | In distribution | |
| MiYO 850 Esthetic System Kit | In distribution | |
| MiYO Gingival Venule Powder 4g | In distribution | |
| MiYO 850 Glaze Fluor Paste 4g | In distribution | |
| MiYO High Performance Glaze Paste 3g | In distribution | |
| MiYO Hi Fusing Gingival Structure Orchid Paste 4g | In distribution | |
| MiYO 850 Trans Straw Fluor Paste 4g | In distribution | |
| MiYO 3D Trans Shade 10 Fluor Paste 4g | In distribution | |
| MiYO Trans Straw Fluor paste 4g | In distribution | |
| MiYO 850 Snow Fluor Paste 4g | In distribution | |
| MiYO Gingival Sorbet Paste 4g | In distribution | |
| MiYO 3D Trans Shade 8 Fluor Paste 4g | In distribution | |
| MiYO 850 Fissure Fluor Paste 4g | In distribution | |
| MiYO Snow Fluor paste 4g | In distribution | |
| MiYO Hi Fusing Gingival Structure Frost Paste 4g | In distribution | |
| MiYO Gingival Trans Copper Paste 4g | In distribution | |
| MiYO Linen Fluor paste 4g | In distribution | |
| MiYO Gingival Flamingo Paste 4g | In distribution | |
| MiYO Trans Shade D Fluor paste 4g | In distribution | |
| MiYO 3D Trans Shade 7 Fluor Paste 4g | In distribution | |
| MiYO 3D Trans Shade 1 Fluor Paste 4g | In distribution | |
| MiYO Trans Smoke Fluor paste 4g | In distribution | |
| MiYO 3D Trans Shade 11 Fluor Paste 4g | In distribution | |
| MiYO 850 Trans Lumin Fluor Paste 4g | In distribution | |
| MiYO Gingival Esthetic System Kit | In distribution | |
| MiYO Gingival Glaze paste no Fluor 4g | In distribution | |
| MiYO Trans Moss Fluor Paste 4g | In distribution | |
| MiYO Trans Lumin Fluor paste 4g | In distribution | |
| MiYO Enamel Effect Liquid Jensen XT | In distribution | |
| MiYO Structure Enamel High Fusing Paste 4g | In distribution | |
| MiYO 3D Trans Shade 6 Fluor Paste 4g | In distribution | |
| MiYO Gingival Thistle Paste 4g | In distribution | |
| MiYO Gingival Plum Paste 4g | In distribution | |
| MiYO Trans Shade C Fluor paste 4g | In distribution | |
| MiYO Esthetic System Chairside Kit | In distribution | |
| MiYO 850 Trans Shade A Fluor Paste 4g | In distribution | |
| MiYO 850 Trans Clementine Fluor Paste 4g | In distribution | |
| MiYO Trans Clementine Fluor paste 4g | In distribution | |
| MiYO 850 Trans Shade C Fluor Paste 4g | In distribution | |
| MiYO Gingival Trans Midnight Paste 4g | In distribution | |
| MiYO Enamel Effect Liquid Jensen XT 15ml | In distribution | |
| MiYO Trans Shade A Fluor paste 4g | In distribution | |
| MiYO Trans Night Fluor Paste 4g | In distribution | |
| MiYO 3D Esthetic System Core Kit | In distribution | |
| MiYO 3D Trans Shade 4 Fluor Paste 4g | In distribution | |
| MiYO Halo Spring Fluor paste 4g | In distribution | |
| MiYO Structure Window High Fusing Paste 4g | In distribution | |
| MiYO Gingival Merlot Paste 4g | In distribution | |
| MiYO Esthetic System Chairside Kit | In distribution | |
| MiYO 850 Trans Storm Fluor Paste 4g | In distribution | |
| MiYO Structure Enamel Flour paste 4g | In distribution | |
| MiYO 850 Trans Shade B Fluor Paste 4g | In distribution | |
| MiYO Gingival Structure Rouge paste 4g | In distribution |
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 |
|---|---|
| K183408 | 2019-03-20 |
| K142043 | 2014-12-18 |
| K112806 | 2011-12-01 |
| K111743 | 2011-09-14 |
| K070114 | 2007-03-01 |
| K050838 | 2005-05-04 |
| K043201 | 2005-01-11 |
| K043221 | 2004-12-20 |
| K002904 | 2000-11-06 |
| K002041 | 2000-08-16 |
| K981490 | 1998-10-22 |
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.