Ceramco® II Silver™
B Masking, Red-Yellow
33manufacturers in China registered for this device type
209catalogue 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 | 2016-09-21 |
| Record revised | 2023-12-13 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Sizes | Weight 10 to 113.4 g |
| Distribution end date | 2022-05-05 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Chroma Modifiers Red-Brown | Weight 10 g | Withdrawn |
| Opaceous Modifiers Orange-Brown | Weight 10 g | Withdrawn |
| High Value Paint-O-Pake G Shades D-3 | Weight 28.4 g | Withdrawn |
| Opal Incisal Porcelains White | Weight 10 g | Withdrawn |
| Chroma Modifiers | Weight 10 g | Withdrawn |
| Paint-O-Pake A-1 | Weight 113.4 g | Withdrawn |
| High Value Paint-O-Pake G Shades B-4 | Weight 28.4 g | Withdrawn |
| Hue Modifiers Yellow | Weight 10 g | Withdrawn |
| Paint-O-Pake B-2 | Weight 28.4 g | Withdrawn |
| Body Shades C-2 | Weight 113.4 g | Withdrawn |
| Incisal Porcelain Yellow | Weight 28.4 g | Withdrawn |
| Paint-O-Pake C-2 | Weight 113.4 g | Withdrawn |
| High Value Paint-O-Pake G Shades A-3 | Weight 113.4 g | Withdrawn |
| Incisal Porcelain Extra Light | Weight 28.4 g | Withdrawn |
| High Value Paint-O-Pake G Shades B-3 | Weight 28.4 g | Withdrawn |
| Body Shades B-4 | Weight 28.4 g | Withdrawn |
| Paint-O-Pake D-4 | Weight 28.4 g | Withdrawn |
| Opaceous Body Porcelains A-3.5 | Weight 28.4 g | Withdrawn |
| Opal Incisal Porcelains Orange | Weight 10 g | Withdrawn |
| Hue Modifiers Brown | Weight 10 g | Withdrawn |
| High Value Paint-O-Pake G Shades C-2 | Weight 113.4 g | Withdrawn |
| Chroma Modifiers | Weight 10 g | Withdrawn |
| Opal Incisal Porcelains Yellow | Weight 28.4 g | Withdrawn |
| Body Shades A-4 | Weight 113.4 g | Withdrawn |
| High Value Paint-O-Pake G Shades B-2 | Weight 113.4 g | Withdrawn |
| Hue Modifiers White | Weight 10 g | Withdrawn |
| Paint-O-Pake D-3 | Weight 113.4 g | Withdrawn |
| Hue Modifiers White | Weight 10 g | Withdrawn |
| Incisal Porcelain Yellow | Weight 113.4 g | Withdrawn |
| High Value Paint-O-Pake G Shades D-4 | Weight 28.4 g | Withdrawn |
| Incisal Porcelain Transparent | Weight 28.4 g | Withdrawn |
| Incisal Porcelain White | Weight 28.4 g | Withdrawn |
| Opaceous Body Porcelains B-0 | Weight 28.4 g | Withdrawn |
| Chroma Rich Body Porcelains A-1 | Weight 113.4 g | Withdrawn |
| Body Shades C-4 | Weight 113.4 g | Withdrawn |
| Incisal Porcelain Orange | Weight 113.4 g | Withdrawn |
| Body Shades A-3.5 | Weight 113.4 g | Withdrawn |
| Chroma Rich Body Porcelains A-4 | Weight 28.4 g | Withdrawn |
| High Value Paint-O-Pake G Shades C-3 | Weight 113.4 g | Withdrawn |
| Opal Incisal Porcelains Yellow | Weight 10 g | Withdrawn |
| Body Shades B-3 | Weight 113.4 g | Withdrawn |
| Paint-O-Pake B-3 | Weight 28.4 g | Withdrawn |
| Hue Modifiers Gray | Weight 10 g | Withdrawn |
| Incisal Porcelain Light | Weight 28.4 g | Withdrawn |
| High Value Paint-O-Pake G Shades B-4 | Weight 113.4 g | Withdrawn |
| Paint-O-Pake C-1 | Weight 113.4 g | Withdrawn |
| Body Shades A-2 | Weight 28.4 g | Withdrawn |
| High Value Paint-O-Pake G Shades C-3 | Weight 28.4 g | Withdrawn |
| Chroma Modifiers | Weight 10 g | Withdrawn |
| Chroma Modifiers Neutral | Weight 10 g | Withdrawn |
| Chroma Rich Body Porcelains A-1 | Weight 28.4 g | Withdrawn |
| Paint-O-Pake A-1 | Weight 28.4 g | Withdrawn |
| Opaceous Body Porcelains C-1 | Weight 28.4 g | Withdrawn |
| Body Shades A-3.5 | Weight 28.4 g | Withdrawn |
| Tissue Tint Raspberry | Weight 10 g | Withdrawn |
| Body Shades C-3 | Weight 28.4 g | Withdrawn |
| Opaceous Body Porcelains B-3 | Weight 28.4 g | Withdrawn |
| Chroma Rich Body Porcelains A-3.5 | Weight 113.4 g | Withdrawn |
| Paint-O-Pake C-2 | Weight 28.4 g | Withdrawn |
| Chroma Modifiers Gray-Brown | Weight 10 g | Withdrawn |
| Body Shades B-1 | Weight 28.4 g | Withdrawn |
| Paint-O-Pake A-3 | Weight 113.4 g | Withdrawn |
| Body Shades C-3 | Weight 113.4 g | Withdrawn |
| Hue Modifiers Pink | Weight 10 g | Withdrawn |
| Incisal Porcelain Dark | Weight 113.4 g | Withdrawn |
| High Value Paint-O-Pake G Shades B-3 | Weight 113.4 g | Withdrawn |
| Chroma Rich Body Porcelains A-3 | Weight 113.4 g | Withdrawn |
| Tissue Tint Toffee | Weight 10 g | Withdrawn |
| Opal Incisal Porcelains Orange | Weight 28.4 g | Withdrawn |
| High Value Paint-O-Pake G Shades C-4 | Weight 113.4 g | Withdrawn |
| Opal Incisal Porcelains Violet | Weight 28.4 g | Withdrawn |
| High Value Paint-O-Pake G Shades A-1 | Weight 113.4 g | Withdrawn |
| Body Shades A-4 | Weight 28.4 g | Withdrawn |
| Paint-O-Pake A-4 | Weight 113.4 g | Withdrawn |
| Masking Shades | Weight 10 g | Withdrawn |
| Body Shades D-2 | Weight 113.4 g | Withdrawn |
| Opaceous Body Porcelains A-1 | Weight 28.4 g | Withdrawn |
| Paint-O-Pake C-4 | Weight 113.4 g | Withdrawn |
| High Value Paint-O-Pake G Shades A-3.5 | Weight 113.4 g | Withdrawn |
| Universal Tissue Tint Medium | Weight 10 g | Withdrawn |
| Body Shades B-0 | Weight 28.4 g | Withdrawn |
| Body Shades C-1 | Weight 113.4 g | Withdrawn |
| Opaceous Modifiers Green-Brown | Weight 10 g | Withdrawn |
| Paint-O-Pake A-2 | Weight 28.4 g | Withdrawn |
| Opaceous Body Porcelains A-3 | Weight 28.4 g | Withdrawn |
| Body Shades C-4 | Weight 28.4 g | Withdrawn |
| Incisal Porcelain Medium | Weight 28.4 g | Withdrawn |
| Paint-O-Pake C-1 | Weight 28.4 g | Withdrawn |
| High Value Paint-O-Pake G Shades A-2 | Weight 28.4 g | Withdrawn |
| Hue Modifiers Orange | Weight 10 g | Withdrawn |
| Paint-O-Pake B-0 | Weight 28.4 g | Withdrawn |
| Incisal Porcelain Pink | Weight 113.4 g | Withdrawn |
| High Value Paint-O-Pake G Shades C-4 | Weight 28.4 g | Withdrawn |
| High Value Paint-O-Pake G Shades C-1 | Weight 28.4 g | Withdrawn |
| Chroma Rich Body Porcelains A-2 | Weight 28.4 g | Withdrawn |
| High Value Paint-O-Pake G Shades A-3.5 | Weight 28.4 g | Withdrawn |
| Opal Incisal Porcelains Ivory | Weight 10 g | Withdrawn |
| Body Shades D-2 | Weight 28.4 g | Withdrawn |
| Opaceous Modifiers Honey Yellow | Weight 10 g | Withdrawn |
| Masking Shades | Weight 10 g | Withdrawn |
| High Value Paint-O-Pake G Shades B-1 | Weight 28.4 g | Withdrawn |
| Incisal Porcelain Extra Light | Weight 113.4 g | Withdrawn |
| Body Shades C-1 | Weight 28.4 g | Withdrawn |
| Hue Modifiers Orange | Weight 10 g | Withdrawn |
| Body Shades A-1 | Weight 113.4 g | Withdrawn |
| Body Shades B-4 | Weight 113.4 g | Withdrawn |
| Paint-O-Pake A-3 | Weight 28.4 g | Withdrawn |
| High Value Paint-O-Pake G Shades B-1 | Weight 113.4 g | Withdrawn |
| Opal Incisal Porcelains Blue | Weight 10 g | Withdrawn |
| High Value Paint-O-Pake G Shades A-3 | Weight 28.4 g | Withdrawn |
| Universal Tissue Tint Dark | Weight 10 g | Withdrawn |
| Add-On Porcelain Light | Weight 10 g | Withdrawn |
| Add-On Porcelain Dark | Weight 10 g | Withdrawn |
| Body Shades A-3 | Weight 113.4 g | Withdrawn |
| Paint-O-Pake D-2 | Weight 28.4 g | Withdrawn |
| Opaceous Body Porcelains D-3 | Weight 28.4 g | Withdrawn |
| Body Porcelain Kit | Withdrawn | |
| High Value Paint-O-Pake G Shades C-1 | Weight 113.4 g | Withdrawn |
| Paint-O-Pake D-2 | Weight 113.4 g | Withdrawn |
| Opaceous Body Porcelains A-2 | Weight 28.4 g | Withdrawn |
| Paint-O-Pake D-3 | Weight 28.4 g | Withdrawn |
| Opaceous Body Porcelains D-4 | Weight 28.4 g | Withdrawn |
| Incisal Porcelain Translucent | Weight 28.4 g | Withdrawn |
| Paint-O-Pake B-1 | Weight 113.4 g | Withdrawn |
| Opal Incisal Porcelains Ivory | Weight 28.4 g | Withdrawn |
| High Value Paint-O-Pake G Shades A-2 | Weight 113.4 g | Withdrawn |
| Incisal Porcelain Light | Weight 113.4 g | Withdrawn |
| Paint-O-Pake D-4 | Weight 113.4 g | Withdrawn |
| Body Shades B-2 | Weight 28.4 g | Withdrawn |
| Opaceous Modifiers Peach | Weight 10 g | Withdrawn |
| Paint-O-Pake A-4 | Weight 28.4 g | Withdrawn |
| Opal Incisal Porcelains Pink | Weight 28.4 g | Withdrawn |
| Paint-O-Pake B-4 | Weight 113.4 g | Withdrawn |
| Chroma Modifiers Red-Yellow | Weight 10 g | Withdrawn |
| Chroma Modifiers | Weight 10 g | Withdrawn |
| Opal Incisal Porcelains Violet | Weight 10 g | Withdrawn |
| Opal Incisal Porcelains Dark | Weight 28.4 g | Withdrawn |
| Incisal Porcelain Pink | Weight 28.4 g | Withdrawn |
| Paint-O-Pake A-3.5 | Weight 113.4 g | Withdrawn |
| Masking Shades | Weight 10 g | Withdrawn |
| High Value Paint-O-Pake G Shades D-3 | Weight 113.4 g | Withdrawn |
| Body Shades D-4 | Weight 28.4 g | Withdrawn |
| Opal Incisal Porcelains Light | Weight 28.4 g | Withdrawn |
| Body Shades B-1 | Weight 113.4 g | Withdrawn |
| Hue Modifiers Pink | Weight 10 g | Withdrawn |
| Incisal Porcelain Orange | Weight 28.4 g | Withdrawn |
| Paint-O-Pake C-3 | Weight 113.4 g | Withdrawn |
| Paint-O-Pake A-3.5 | Weight 28.4 g | Withdrawn |
| Body Shades A-2 | Weight 113.4 g | Withdrawn |
| Opaceous Body Porcelains C-2 | Weight 28.4 g | Withdrawn |
| Paint-O-Pake A-0 | Weight 28.4 g | Withdrawn |
| Hue Modifiers Violet | Weight 10 g | Withdrawn |
| Opal Incisal Porcelains Pink | Weight 10 g | Withdrawn |
| Body Shades C-2 | Weight 28.4 g | Withdrawn |
| High Value Paint-O-Pake G Shades A-4 | Weight 28.4 g | Withdrawn |
| Paint-O-Pake A-2 | Weight 113.4 g | Withdrawn |
| Opaceous Body Porcelains A-4 | Weight 28.4 g | Withdrawn |
| High Value Paint-O-Pake G Shades C-2 | Weight 28.4 g | Withdrawn |
| Opal Incisal Porcelains Dark | Weight 10 g | Withdrawn |
| Chroma Modifiers | Weight 10 g | Withdrawn |
| Masking Shades | Weight 10 g | Withdrawn |
| Opaceous Body Porcelains C-4 | Weight 28.4 g | Withdrawn |
| Paint-O-Pake B-4 | Weight 28.4 g | Withdrawn |
| High Value Paint-O-Pake G Shades D-2 | Weight 113.4 g | Withdrawn |
| Opaceous Body Porcelains B-1 | Weight 28.4 g | Withdrawn |
| High Value Paint-O-Pake G Shades B-2 | Weight 28.4 g | Withdrawn |
| Opaceous Body Porcelains D-2 | Weight 28.4 g | Withdrawn |
| Body Shades A-3 | Weight 28.4 g | Withdrawn |
| Chroma Rich Body Porcelains A-3 | Weight 28.4 g | Withdrawn |
| Paint-O-Pake B-3 | Weight 113.4 g | Withdrawn |
| Body Shades B-3 | Weight 28.4 g | Withdrawn |
| Opal Incisal Porcelains Medium | Weight 10 g | Withdrawn |
| Body Shades D-3 | Weight 113.4 g | Withdrawn |
| High Value Paint-O-Pake G Shades A-1 | Weight 28.4 g | Withdrawn |
| Opal Incisal Porcelains Blue | Weight 28.4 g | Withdrawn |
| Opaceous Modifiers Yellow-Red | Weight 10 g | Withdrawn |
| Body Shades D-4 | Weight 113.4 g | Withdrawn |
| High Value Paint-O-Pake G Shades A-4 | Weight 113.4 g | Withdrawn |
| Chroma Rich Body Porcelains A-3.5 | Weight 28.4 g | Withdrawn |
| Incisal Porcelain White | Weight 113.4 g | Withdrawn |
| Paint-O-Pake C-4 | Weight 28.4 g | Withdrawn |
| Opal Incisal Porcelains Medium | Weight 28.4 g | Withdrawn |
| High Value Paint-O-Pake G Shades D-4 | Weight 113.4 g | Withdrawn |
| Add-On Porcelain Medium | Weight 10 g | Withdrawn |
| Opal Incisal Porcelains White | Weight 28.4 g | Withdrawn |
| Universal Tissue Tint Light | Weight 10 g | Withdrawn |
| Opaceous Body Porcelains C-3 | Weight 28.4 g | Withdrawn |
| Chroma Rich Body Porcelains A-4 | Weight 113.4 g | Withdrawn |
| Paint-O-Pake C-3 | Weight 28.4 g | Withdrawn |
| Hue Modifiers Yellow | Weight 10 g | Withdrawn |
| Hue Modifiers Blue | Weight 10 g | Withdrawn |
| Tissue Tint Salmon | Weight 10 g | Withdrawn |
| Add-On Porcelain Translucent | Weight 10 g | Withdrawn |
| Opaceous Body Porcelains A-0 | Weight 28.4 g | Withdrawn |
| Body Shades A-0 | Weight 28.4 g | Withdrawn |
| Incisal Porcelain Dark | Weight 28.4 g | Withdrawn |
| Opal Incisal Porcelains Light | Weight 10 g | Withdrawn |
| Tissue Tint Bubblegum | Weight 10 g | Withdrawn |
| Paint-O-Pake B-2 | Weight 113.4 g | Withdrawn |
| Incisal Porcelain Medium | Weight 113.4 g | Withdrawn |
| Body Shades B-2 | Weight 113.4 g | Withdrawn |
| Chroma Rich Body Porcelains A-2 | Weight 113.4 g | Withdrawn |
| Opaceous Body Porcelains B-4 | Weight 28.4 g | Withdrawn |
| Opaceous Body Porcelains B-2 | Weight 28.4 g | Withdrawn |
| Body Shades A-1 | Weight 28.4 g | Withdrawn |
| High Value Paint-O-Pake G Shades D-2 | Weight 28.4 g | Withdrawn |
| Chroma Modifiers | Weight 10 g | Withdrawn |
| Paint-O-Pake B-1 | Weight 28.4 g | Withdrawn |
| Body Shades D-3 | Weight 28.4 g | 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.