Dentsply Sirona®
Overglaze High Flu
33manufacturers in China registered for this device type
28catalogue numbers in this listing
27510(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 | Dentsply LLC, United States |
|---|---|
| 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 | 2016-11-04 |
| Record revised | 2025-03-24 (version 4) |
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 |
| Sizes | Weight 5 to 15 g |
| Distribution end date | 2022-05-05 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Universal | Weight 5 g | In distribution |
| Universal | Weight 5 g | In distribution |
| Universal | Weight 5 g | In distribution |
| Universal | Weight 5 g | In distribution |
| Universal | Weight 15 g | In distribution |
| Universal | Weight 5 g | In distribution |
| Universal | Weight 5 g | In distribution |
| Universal | Weight 5 g | In distribution |
| Universal | Weight 5 g | In distribution |
| Universal | Weight 5 g | In distribution |
| Universal | Weight 5 g | In distribution |
| Universal | Weight 5 g | In distribution |
| Universal | Weight 5 g | In distribution |
| Universal | Weight 5 g | In distribution |
| Universal | Weight 5 g | In distribution |
| Universal | Weight 5 g | In distribution |
| Universal | Weight 5 g | In distribution |
| Universal | Weight 5 g | In distribution |
| Universal | Weight 15 g | In distribution |
| Universal | Weight 5 g | In distribution |
| Universal | Weight 5 g | In distribution |
| Universal Stain and Overglaze Kit | In distribution | |
| Universal | Weight 5 g | In distribution |
| Universal | Weight 5 g | In distribution |
| Universal | Weight 5 g | In distribution |
| Universal | Weight 5 g | In distribution |
| Universal | Weight 5 g | In distribution |
| Universal Stain & Glaze Mini Stain Kit | 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 |
|---|---|
| K152247 | 2016-01-29 |
| K123615 | 2013-02-22 |
| K112152 | 2011-11-09 |
| K091706 | 2009-08-28 |
| K070019 | 2007-01-26 |
| K051462 | 2005-06-24 |
| K043247 | 2004-12-22 |
| K041707 | 2004-07-30 |
| K041335 | 2004-06-16 |
| K040635 | 2004-03-30 |
| K040421 | 2004-03-18 |
| K040420 | 2004-03-18 |
| K033667 | 2004-01-23 |
| K033553 | 2003-12-02 |
| K022796 | 2002-09-06 |
| K971869 | 1997-09-11 |
| K961291 | 1996-05-28 |
| K954761 | 1995-11-02 |
| K943582 | 1994-08-29 |
| K940252 | 1994-03-01 |
| K921619 | 1992-07-02 |
| K915543 | 1992-03-19 |
| K900393 | 1990-04-16 |
| K853707 | 1985-11-19 |
| K830955 | 1983-05-09 |
| K830553 | 1983-04-06 |
| K810096 | 1981-03-04 |
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.