Ceramco® 3
Reddish Pink Tissue Tint
33manufacturers in China registered for this device type
426catalogue 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 | 2026-02-06 (version 5) |
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 3 to 113.4 g; total volume 2 to 3.5 ml |
| Distribution end date | 2024-03-26 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Natural Enamel Blue | Weight 113.4 g | In distribution |
| Add-On Porcelain | Weight 28.4 g | In distribution |
| Paste Opaque C3 | Total Volume 2 ml | In distribution |
| Dentin C3-420 | Weight 28.4 g | In distribution |
| Opaceous Dentin A2 | Weight 28.4 g | In distribution |
| Opaceous Dentin C3-314 | Weight 28.4 g | In distribution |
| Powder Opaque B3 | Weight 28.4 g | In distribution |
| Overglaze | Weight 28.4 g | In distribution |
| Dentin i6 | Weight 113.4 g | In distribution |
| Opaceous Dentin A4 | Weight 113.4 g | In distribution |
| HC1 Dentin Modifer | Weight 28.4 g | In distribution |
| Dentin i4 | Weight 28.4 g | In distribution |
| Paste Opaque Shade Series C3-204 | Total Volume 2 ml | In distribution |
| Powder Opaque D2 | Weight 28.4 g | In distribution |
| Opaceous Dentin C2 | Weight 113.4 g | In distribution |
| Paste Opaque Shade Series C3-101 | Total Volume 2 ml | In distribution |
| Dentin C3-418 | Weight 28.4 g | In distribution |
| Opal Enamel Clear | Weight 28.4 g | In distribution |
| Opaceous Dentin A3.5 | Weight 113.4 g | In distribution |
| Final Margin i1 | Weight 10 g | In distribution |
| Powder Opaque C3-524 | Weight 28.4 g | In distribution |
| Paste Opaque Modifiers Pink | Total Volume 3.5 ml | In distribution |
| Opaceous Dentin B4 | Weight 113.4 g | In distribution |
| Paste Opaque Shade Series C3-203 | Total Volume 2 ml | In distribution |
| Dentin i7 | Weight 113.4 g | In distribution |
| Shade Series Enamel Light | Weight 28.4 g | In distribution |
| Paste Opaque Shade Series C3-421 | Total Volume 2 ml | In distribution |
| Powder Opaque D3 | Weight 113.4 g | In distribution |
| Paste Opaque D2 | Total Volume 2 ml | In distribution |
| Natural Enamel White | Weight 113.4 g | In distribution |
| Opaceous Dentin A2 | Weight 113.4 g | In distribution |
| Natural Enamel Blue | Weight 28.4 g | In distribution |
| Opaque Corrector Dark | Weight 28.4 g | In distribution |
| Opaceous Dentin i1 | Weight 113.4 g | In distribution |
| Paste Opaque B3 | Total Volume 2 ml | In distribution |
| Dentin Modifier C3 | Weight 28.4 g | In distribution |
| Powder Opaque C3-526 | Weight 28.4 g | In distribution |
| HC6 Dentin Modifier | Weight 28.4 g | In distribution |
| Dentin B3 | Weight 113.4 g | In distribution |
| Powder Opaque C3 | Weight 28.4 g | In distribution |
| Powder Opaque A4 | Weight 113.4 g | In distribution |
| Powder Opaque C3-525 | Weight 28.4 g | In distribution |
| Opaceous Dentin B2 | Weight 113.4 g | In distribution |
| Opaceous Dentin C3-423 | Weight 28.4 g | In distribution |
| Dentin C3-206 | Weight 28.4 g | In distribution |
| Opaceous Dentin C3-208 | Weight 28.4 g | In distribution |
| Dentin Modifier A3.5 | Weight 28.4 g | In distribution |
| Add-On Porcelain | Weight 28.4 g | In distribution |
| Paste Opaque Crystals Light | Weight 10 g | In distribution |
| Paste Opaque B1 | Total Volume 2 ml | In distribution |
| Margin C1 | Weight 28.4 g | In distribution |
| Dentin C3-102 | Weight 28.4 g | In distribution |
| Dentin D3 | Weight 28.4 g | In distribution |
| Paste Opaque Shade Series C3-208 | Total Volume 2 ml | In distribution |
| Paste Opaque A3.5 | Total Volume 2 ml | In distribution |
| Dentin i2 | Weight 113.4 g | In distribution |
| Dentin B4 | Weight 113.4 g | In distribution |
| Dentin A3.5 | Weight 113.4 g | In distribution |
| Natural Enamel Extra Light | Weight 28.4 g | In distribution |
| Opaceous Dentin C3-209 | Weight 28.4 g | In distribution |
| Powder Opaque Modifier Tan | Weight 28.4 g | In distribution |
| Powder Opaque C3-314 | Weight 28.4 g | In distribution |
| Powder Opaque D3 | Weight 28.4 g | In distribution |
| Dentin B2 | Weight 28.4 g | In distribution |
| Powder Opaque A2 | Weight 28.4 g | In distribution |
| Opaceous Dentin C3-311 | Weight 28.4 g | In distribution |
| Add-On Porcelain | Weight 28.4 g | In distribution |
| Dentin D3 | Weight 113.4 g | In distribution |
| Powder Opaque Modifier Gray | Weight 28.4 g | In distribution |
| Final Margin A3 | Weight 10 g | In distribution |
| Powder Opaque B1 | Weight 113.4 g | In distribution |
| Opal Enamel Light | Weight 28.4 g | In distribution |
| Opaceous Dentin C3-207 | Weight 28.4 g | In distribution |
| Powder Opaque C3-207 | Weight 28.4 g | In distribution |
| Powder Opaque C3-310 | Weight 28.4 g | In distribution |
| Dentin C1 | Weight 113.4 g | In distribution |
| Opal Enamel White | Weight 28.4 g | In distribution |
| Powder Opaque i1/i3 | Weight 28.4 g | In distribution |
| Dentin i4 | Weight 28.4 g | In distribution |
| Opaceous Dentin D2 | Weight 28.4 g | In distribution |
| Dentin Modifier A1 | Weight 28.4 g | In distribution |
| Paste Opaque Shade Series C3-206 | Total Volume 2 ml | In distribution |
| Paste Opaque Shade Series C3-315 | Total Volume 2 ml | In distribution |
| Opaceous Dentin i2 | Weight 28.4 g | In distribution |
| Dentin Modifier Gray | Weight 28.4 g | In distribution |
| Paste Opaque Shade Series C3-524 | Total Volume 2 ml | In distribution |
| Paste Opaque Shade Series C3-316 | Total Volume 2 ml | In distribution |
| Opaceous Dentin C3-316 | Weight 28.4 g | In distribution |
| Powder Opaque Modifier White | Weight 28.4 g | In distribution |
| Dentin Modifier B3 | Weight 28.4 g | In distribution |
| Opaceous Dentin C3-420 | Weight 28.4 g | In distribution |
| Paste Opaque Shade Series C3-312 | Total Volume 2 ml | In distribution |
| Dentin i2 | Weight 28.4 g | In distribution |
| Mamelon Red-Orange/Amber | Weight 28.4 g | In distribution |
| Opaceous Dentin B4 | Weight 28.4 g | In distribution |
| Opaceous Dentin A4 | Weight 28.4 g | In distribution |
| Natural Enamel Yellow | Weight 113.4 g | In distribution |
| Opaceous Dentin i5 | Weight 113.4 g | In distribution |
| Margin Orange-Brown | Weight 28.4 g | In distribution |
| Shade A2 Trial Kit | In distribution | |
| Dentin C2 | Weight 113.4 g | In distribution |
| Powder Opaque Modifier Ochre | Weight 28.4 g | In distribution |
| Natural Enamel Dark | Weight 28.4 g | In distribution |
| Powder Opaque C3-206 | Weight 28.4 g | In distribution |
| Natural Enamel Pink | Weight 113.4 g | In distribution |
| Powder Opaque A1 | Weight 113.4 g | In distribution |
| Dentin C1 | Weight 28.4 g | In distribution |
| Powder Opaque C3-419 | Weight 28.4 g | In distribution |
| Opaceous Dentin C3-422 | Weight 28.4 g | In distribution |
| Opaceous Dentin C4 | Weight 28.4 g | In distribution |
| Opaceous Dentin i1 | Weight 28.4 g | In distribution |
| Powder Opaque C2 | Weight 113.4 g | In distribution |
| Paste Opaque Modifiers Ochre | Total Volume 3.5 ml | In distribution |
| Powder Opaque C3-418 | Weight 28.4 g | In distribution |
| Dentin Modifier C1 | Weight 28.4 g | In distribution |
| Dentin A3 | Weight 113.4 g | In distribution |
| Dentin C3-313 | Weight 28.4 g | In distribution |
| Powder Opaque A3 | Weight 28.4 g | In distribution |
| Dentin C4 | Weight 113.4 g | In distribution |
| Paste Opaque Modifiers Gray | Total Volume 3.5 ml | In distribution |
| Mamelon Yellow-Orange/Coral | Weight 28.4 g | In distribution |
| Powder Opaque A2 | Weight 113.4 g | In distribution |
| Paste Opaque Modifiers White | Total Volume 3.5 ml | In distribution |
| Paste Opaque Shade Series C3-205 | Total Volume 2 ml | In distribution |
| Add-On Porcelain | Weight 28.4 g | In distribution |
| Opaceous Dentin C3 | Weight 28.4 g | In distribution |
| Paste Opaque D3 | Total Volume 2 ml | In distribution |
| Powder Opaque C3-203 | Weight 28.4 g | In distribution |
| Opaceous Dentin i3 | Weight 28.4 g | In distribution |
| Opaceous Dentin C3-310 | Weight 28.4 g | In distribution |
| Opaceous Dentin C3-206 | Weight 28.4 g | In distribution |
| Paste Opaque Modifiers Blue | Total Volume 3.5 ml | In distribution |
| Powder Opaque B3 | Weight 113.4 g | In distribution |
| Opaceous Dentin i3 | Weight 113.4 g | In distribution |
| Paste Opaque Crystals White | Weight 10 g | In distribution |
| Dentin i7 | Weight 28.4 g | In distribution |
| Paste Opaque A1 | Total Volume 2 ml | In distribution |
| Natural Enamel Violet | Weight 113.4 g | In distribution |
| Margin i2 | Weight 28.4 g | In distribution |
| Powder Opaque A3 | Weight 113.4 g | In distribution |
| Powder Opaque Modifier Pink | Weight 28.4 g | In distribution |
| Powder Opaque C3-420 | Weight 28.4 g | In distribution |
| Dentin Modifier White | Weight 28.4 g | In distribution |
| Paste Opaque i2/i4 | Total Volume 2 ml | In distribution |
| Dentin A1 | Weight 28.4 g | In distribution |
| Powder Opaque C3-209 | Weight 28.4 g | In distribution |
| Powder Opaque C3-204 | Weight 28.4 g | In distribution |
| Opaceous Dentin A1 | Weight 113.4 g | In distribution |
| Opaceous Dentin C3-421 | Weight 28.4 g | In distribution |
| Opaceous Dentin C2 | Weight 28.4 g | In distribution |
| Shade Series Enamel Medium | Weight 28.4 g | In distribution |
| Opaceous Dentin D4 | Weight 113.4 g | In distribution |
| Powder Opaque C3-102 | Weight 28.4 g | In distribution |
| Margin White | Weight 28.4 g | In distribution |
| Dentin C3-101 | Weight 28.4 g | In distribution |
| Powder Opaque i1/i3 | Weight 113.4 g | In distribution |
| Dentin C3-419 | Weight 28.4 g | In distribution |
| Paste Opaque Shade Series C3-526 | Total Volume 2 ml | In distribution |
| Natural Enamel White | Weight 28.4 g | In distribution |
| Dentin C3-526 | Weight 28.4 g | In distribution |
| Margin B2 | Weight 28.4 g | In distribution |
| Dentin A2 | Weight 28.4 g | In distribution |
| Powder Opaque i2/i4 | Weight 113.4 g | In distribution |
| Paste Opaque Shade Series C3-209 | Total Volume 2 ml | In distribution |
| Paste Opaque A4 | Total Volume 2 ml | In distribution |
| Add-On Porcelain | Weight 28.4 g | In distribution |
| Dentin C3-209 | Weight 28.4 g | In distribution |
| Opaceous Dentin i5 | Weight 28.4 g | In distribution |
| Dentin Modifier Pink | Weight 28.4 g | In distribution |
| Margin i5 | Weight 28.4 g | In distribution |
| Powder Opaque C1 | Weight 28.4 g | In distribution |
| Dentin i3 | Weight 113.4 g | In distribution |
| Opaceous Dentin A3 | Weight 113.4 g | In distribution |
| Opaceous Dentin i8 | Weight 113.4 g | In distribution |
| Paste Opaque C2 | Total Volume 2 ml | In distribution |
| Powder Opaque A4 | Weight 28.4 g | In distribution |
| Powder Opaque C3-101 | Weight 28.4 g | In distribution |
| Powder Opaque i2/i4 | Weight 28.4 g | In distribution |
| Dentin Modifier Yellow | Weight 28.4 g | In distribution |
| Natural Enamel Clear | Weight 28.4 g | In distribution |
| Final Margin C1 | Weight 10 g | In distribution |
| Powder Opaque C3-316 | Weight 28.4 g | In distribution |
| Add-On Porcelain | Weight 28.4 g | In distribution |
| Opaceous Dentin C3-204 | Weight 28.4 g | In distribution |
| Opaceous Dentin i4 | Weight 113.4 g | In distribution |
| Opaceous Dentin B2 | Weight 28.4 g | In distribution |
| Dentin C3-524 | Weight 28.4 g | In distribution |
| Paste Opaque Modifiers Sienna | Total Volume 3.5 ml | In distribution |
| Natural Enamel Medium | Weight 113.4 g | In distribution |
| Margin i1 | Weight 28.4 g | In distribution |
| Powder Opaque B2 | Weight 28.4 g | In distribution |
| Dentin i8 | Weight 113.4 g | In distribution |
| Powder Opaque D4 | Weight 28.4 g | In distribution |
| Dentin C3-203 | Weight 28.4 g | In distribution |
| Dentin C3-417 | Weight 28.4 g | In distribution |
| Dentin A3 | Weight 28.4 g | In distribution |
| Paste Opaque C1 | Total Volume 2 ml | In distribution |
| Opaceous Dentin i2 | Weight 113.4 g | In distribution |
| Opaceous Dentin C1 | Weight 113.4 g | In distribution |
| Dentin C3 | Weight 113.4 g | In distribution |
| White Base Paste Shades i1-i8 | Total Volume 2 ml | In distribution |
| Opaceous Dentin A3.5 | Weight 28.4 g | In distribution |
| Natural Enamel Dark | Weight 113.4 g | In distribution |
| Powder Opaque C3-312 | Weight 28.4 g | In distribution |
| Dentin C3-525 | Weight 28.4 g | In distribution |
| Powder Opaque C1 | Weight 113.4 g | In distribution |
| Powder Opaque C3-311 | Weight 28.4 g | In distribution |
| Natural Enamel Orange | Weight 113.4 g | In distribution |
| Opaceous Dentin C3-419 | Weight 28.4 g | In distribution |
| Paste Opaque B2 | Total Volume 2 ml | In distribution |
| HC2 Dentin Modifer | Weight 28.4 g | In distribution |
| Powder Opaque C3-422 | Weight 28.4 g | In distribution |
| Natural Enamel Light | Weight 113.4 g | In distribution |
| Powder Opaque i5/i7 | Weight 28.4 g | In distribution |
| Opaceous Dentin C3-313 | Weight 28.4 g | In distribution |
| Paste Opaque A3 | Total Volume 2 ml | In distribution |
| Natural Enamel Pink | Weight 28.4 g | In distribution |
| Natural Enamel Light | Weight 28.4 g | In distribution |
| Powder Opaque A1 | Weight 28.4 g | In distribution |
| Dentin i3 | Weight 28.4 g | In distribution |
| Opaceous Dentin C3-524 | Weight 28.4 g | In distribution |
| Margin Peach | Weight 28.4 g | In distribution |
| Powder Opaque i6/i8 | Weight 113.4 g | In distribution |
| Powder Opaque C3-423 | Weight 28.4 g | In distribution |
| Opaceous Dentin C3-101 | Weight 28.4 g | In distribution |
| Final Margin A4 | Weight 10 g | In distribution |
| Opaceous Dentin i7 | Weight 113.4 g | In distribution |
| Opaceous Dentin A3 | Weight 28.4 g | In distribution |
| Opaceous Dentin C3-312 | Weight 28.4 g | In distribution |
| Natural Enamel Yellow | Weight 28.4 g | In distribution |
| Final Margin i2 | Weight 10 g | In distribution |
| Powder Opaque C3-205 | Weight 28.4 g | In distribution |
| Opaceous Dentin C3-525 | Weight 28.4 g | In distribution |
| Dentin A2 | Weight 28.4 g | In distribution |
| Opaceous Dentin i7 | Weight 28.4 g | In distribution |
| Natural Enamel Ivory | Weight 113.4 g | In distribution |
| Paste Opaque Shade Series C3-423 | Total Volume 2 ml | In distribution |
| Powder Opaque i5/i7 | Weight 113.4 g | In distribution |
| HC5 Dentin Modifier | Weight 28.4 g | In distribution |
| Dentin D4 | Weight 28.4 g | In distribution |
| Dentin C2 | Weight 28.4 g | In distribution |
| Dentin A1 | Weight 113.4 g | In distribution |
| Margin A3 | Weight 28.4 g | In distribution |
| Powder Opaque C4 | Weight 113.4 g | In distribution |
| Opaceous Dentin C3-417 | Weight 28.4 g | In distribution |
| Paste Opaque Modifiers Orange | Total Volume 3.5 ml | In distribution |
| Add-On Porcelain | Weight 28.4 g | In distribution |
| Powder Opaque D2 | Weight 113.4 g | In distribution |
| Powder Opaque D4 | Weight 113.4 g | In distribution |
| Dentin C3 | Weight 28.4 g | 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
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.