Ceramco® PFZ
26 Shade Kit
33manufacturers in China registered for this device type
216catalogue 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 |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Weight 3 to 28.4 g |
| Distribution end date | 2022-06-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Opaceous Dentin A1 | Weight 28.4 g | Withdrawn |
| Stain Black | Weight 3 g | Withdrawn |
| Liner Modifier White | Weight 28.4 g | Withdrawn |
| Add-On Reddish Pink Tissue Tint | Weight 28.4 g | Withdrawn |
| Liner Shade Series PZ 310 | Weight 28.4 g | Withdrawn |
| Margin Modifiers Green-Brown | Weight 28.4 g | Withdrawn |
| Liner A2 | Weight 28.4 g | Withdrawn |
| Dentin Modifier Grey | Weight 28.4 g | Withdrawn |
| Liner Shade Series PZ 311 | Weight 28.4 g | Withdrawn |
| Natural Enamel Violet | Weight 28.4 g | Withdrawn |
| Dentin Shade Series PZ 315 | Weight 28.4 g | Withdrawn |
| Dentin Shade Series PZ 526 | Weight 28.4 g | Withdrawn |
| Margin Modifiers Orange Brown | Weight 28.4 g | Withdrawn |
| Dentin Shade Series PZ 204 | Weight 28.4 g | Withdrawn |
| Liner Shade Series PZ 316 | Weight 28.4 g | Withdrawn |
| Margin C3 | Weight 28.4 g | Withdrawn |
| Opaceous Dentin Shade Series PZ 526 | Weight 28.4 g | Withdrawn |
| Opaceous Dentin A2 | Weight 28.4 g | Withdrawn |
| Dentin Shade Series PZ 205 | Weight 28.4 g | Withdrawn |
| Natural Enamel Pink | Weight 28.4 g | Withdrawn |
| Opaceous Dentin Shade Series PZ 524 | Weight 28.4 g | Withdrawn |
| Dentin Modifier B3 | Weight 28.4 g | Withdrawn |
| Opaceous Dentin Shade Series PZ 419 | Weight 28.4 g | Withdrawn |
| Natural Enamel Clear | Weight 28.4 g | Withdrawn |
| Liner Shade Series PZ 209 | Weight 28.4 g | Withdrawn |
| Overglaze | Weight 28.4 g | Withdrawn |
| Opaceous Dentin A3 | Weight 28.4 g | Withdrawn |
| Margin A1 | Weight 28.4 g | Withdrawn |
| Opaceous Dentin A3.5 | Weight 28.4 g | Withdrawn |
| PZ Shade Series Shades | Withdrawn | |
| A2 Trial Kit | Withdrawn | |
| Dentin D2 | Weight 28.4 g | Withdrawn |
| Liner Modifier Violet | Weight 28.4 g | Withdrawn |
| Dentin Shade Series PZ 310 | Weight 28.4 g | Withdrawn |
| Stain Vanilla | Weight 3 g | Withdrawn |
| Opaceous Dentin Shade Series PZ 205 | Weight 28.4 g | Withdrawn |
| Add-On Translucent | Weight 28.4 g | Withdrawn |
| Opal Enamel Clear | Weight 28.4 g | Withdrawn |
| Add-On Pink Tissue Tint | Weight 28.4 g | Withdrawn |
| Opaceous Dentin A4 | Weight 28.4 g | Withdrawn |
| Opaceous Dentin Shade Series PZ 310 | Weight 28.4 g | Withdrawn |
| Dentin Shade Series PZ 313 | Weight 28.4 g | Withdrawn |
| Liner C3 | Weight 28.4 g | Withdrawn |
| Opaceous Dentin i7 | Weight 28.4 g | Withdrawn |
| Dentin Shade Series PZ 524 | Weight 28.4 g | Withdrawn |
| Add-On Salmon Tissue Tint | Weight 28.4 g | Withdrawn |
| Dentin Shade Series PZ 206 | Weight 28.4 g | Withdrawn |
| Liner Shade Series PZ 421 | Weight 28.4 g | Withdrawn |
| Dentin Shade Series PZ 207 | Weight 28.4 g | Withdrawn |
| Liner D2 | Weight 28.4 g | Withdrawn |
| Opaceous Dentin i3 | Weight 28.4 g | Withdrawn |
| Opaceous Dentin Shade Series PZ 204 | Weight 28.4 g | Withdrawn |
| Opaceous Dentin Shade Series PZ 313 | Weight 28.4 g | Withdrawn |
| Dentin B3 | Weight 28.4 g | Withdrawn |
| 16 Shade Powder Kit | Withdrawn | |
| Margin B2 | Weight 28.4 g | Withdrawn |
| Dentin Modifier White | Weight 28.4 g | Withdrawn |
| Opaceous Dentin B1 | Weight 28.4 g | Withdrawn |
| Liner A3.5 | Weight 28.4 g | Withdrawn |
| Dentin Shade Series PZ 420 | Weight 28.4 g | Withdrawn |
| Opaceous Dentin C1 | Weight 28.4 g | Withdrawn |
| Stain Grey | Weight 3 g | Withdrawn |
| Opaceous Dentin C4 | Weight 28.4 g | Withdrawn |
| Liner Shade Series PZ 419 | Weight 28.4 g | Withdrawn |
| Dentin C1 | Weight 28.4 g | Withdrawn |
| Liner Shade Series PZ 204 | Weight 28.4 g | Withdrawn |
| Liner D3 | Weight 28.4 g | Withdrawn |
| Liner illumine | Weight 28.4 g | Withdrawn |
| Dentin A4 | Weight 28.4 g | Withdrawn |
| Opaceous Dentin Shade Series PZ 101 | Weight 28.4 g | Withdrawn |
| Dentin Shade Series PZ 418 | Weight 28.4 g | Withdrawn |
| Dentin Shade Series PZ 209 | Weight 28.4 g | Withdrawn |
| Opaceous Dentin Shade Series PZ 209 | Weight 28.4 g | Withdrawn |
| Dentin C3 | Weight 28.4 g | Withdrawn |
| Liner C4 | Weight 28.4 g | Withdrawn |
| Margin A3 | Weight 28.4 g | Withdrawn |
| Liner Modifier Sienna | Weight 28.4 g | Withdrawn |
| Dentin Modifier Green-Brown | Weight 28.4 g | Withdrawn |
| Margin Modifiers White | Weight 28.4 g | Withdrawn |
| Dentin D3 | Weight 28.4 g | Withdrawn |
| Liner Shade Series PZ 423 | Weight 28.4 g | Withdrawn |
| Stain Orange | Weight 3 g | Withdrawn |
| Dentin Shade Series PZ 423 | Weight 28.4 g | Withdrawn |
| Liner Modifier Yellow | Weight 28.4 g | Withdrawn |
| Liner Shade Series PZ 417 | Weight 28.4 g | Withdrawn |
| Liner Shade Series PZ 314 | Weight 28.4 g | Withdrawn |
| Dentin Modifier C3 | Weight 28.4 g | Withdrawn |
| Liner Shade Series PZ 101 | Weight 28.4 g | Withdrawn |
| Opaceous Dentin Shade Series PZ 417 | Weight 28.4 g | Withdrawn |
| Opaceous Dentin Shade Series PZ 206 | Weight 28.4 g | Withdrawn |
| Dentin Shade Series PZ 316 | Weight 28.4 g | Withdrawn |
| Natural Enamel Light | Weight 28.4 g | Withdrawn |
| Liner Modifier Orange | Weight 28.4 g | Withdrawn |
| Liner Shade Series PZ 525 | Weight 28.4 g | Withdrawn |
| Dentin Modifier Pink | Weight 28.4 g | Withdrawn |
| Dentin i7 | Weight 28.4 g | Withdrawn |
| Opaceous Dentin Shade Series PZ 102 | Weight 28.4 g | Withdrawn |
| Natural Enamel Orange | Weight 28.4 g | Withdrawn |
| Dentin Shade Series PZ 314 | Weight 28.4 g | Withdrawn |
| Liner C1 | Weight 28.4 g | Withdrawn |
| 8 Shade Powder Kit | Withdrawn | |
| Dentin Shade Series PZ 525 | Weight 28.4 g | Withdrawn |
| Dentin Shade Series PZ 203 | Weight 28.4 g | Withdrawn |
| Liner Shade Series PZ 203 | Weight 28.4 g | Withdrawn |
| Stain Dark Orange | Weight 3 g | Withdrawn |
| Margin Modifiers Peach | Weight 28.4 g | Withdrawn |
| Dentin A1 | Weight 28.4 g | Withdrawn |
| Dentin Modifier A1 | Weight 28.4 g | Withdrawn |
| Opaceous Dentin Shade Series PZ 312 | Weight 28.4 g | Withdrawn |
| Opaceous Dentin Shade Series PZ 525 | Weight 28.4 g | Withdrawn |
| Dentin Shade Series PZ 312 | Weight 28.4 g | Withdrawn |
| Opaceous Dentin Shade Series PZ 316 | Weight 28.4 g | Withdrawn |
| Opaceous Dentin C2 | Weight 28.4 g | Withdrawn |
| Dentin Modifier A3.5 | Weight 28.4 g | Withdrawn |
| Liner Modifier Grey | Weight 28.4 g | Withdrawn |
| Opaceous Dentin B3 | Weight 28.4 g | Withdrawn |
| Opal Enamel Light | Weight 28.4 g | Withdrawn |
| Opaceous Dentin Shade Series PZ 422 | Weight 28.4 g | Withdrawn |
| Dentin B1 | Weight 28.4 g | Withdrawn |
| Natural Enamel Yellow | Weight 28.4 g | Withdrawn |
| Opaceous Dentin D3 | Weight 28.4 g | Withdrawn |
| Natural Enamel Medium | Weight 28.4 g | Withdrawn |
| Stain Corn-Yellow | Weight 3 g | Withdrawn |
| Liner A3 | Weight 28.4 g | Withdrawn |
| Dentin A2 | Weight 28.4 g | Withdrawn |
| Stain Yellow | Weight 3 g | Withdrawn |
| Dentin Modifier C1 | Weight 28.4 g | Withdrawn |
| Liner Shade Series PZ 312 | Weight 28.4 g | Withdrawn |
| Liner Shade Series PZ 313 | Weight 28.4 g | Withdrawn |
| Dentin Modifier Violet | Weight 28.4 g | Withdrawn |
| Opaceous Dentin B2 | Weight 28.4 g | Withdrawn |
| Liner C2 | Weight 28.4 g | Withdrawn |
| Opaceous Dentin Shade Series PZ 315 | Weight 28.4 g | Withdrawn |
| Opaceous Dentin B4 | Weight 28.4 g | Withdrawn |
| Dentin Shade Series PZ 422 | Weight 28.4 g | Withdrawn |
| Liner Shade Series PZ 526 | Weight 28.4 g | Withdrawn |
| Liner Shade Series PZ 205 | Weight 28.4 g | Withdrawn |
| Liner Shade Series PZ 420 | Weight 28.4 g | Withdrawn |
| Dentin Modifier Orange-Brown | Weight 28.4 g | Withdrawn |
| Opaceous Dentin Shade Series PZ 207 | Weight 28.4 g | Withdrawn |
| Opaceous Dentin Shade Series PZ 203 | Weight 28.4 g | Withdrawn |
| Liner Shade Series PZ 418 | Weight 28.4 g | Withdrawn |
| Liner Shade Series PZ 315 | Weight 28.4 g | Withdrawn |
| Margin A4 | Weight 28.4 g | Withdrawn |
| Liner B2 | Weight 28.4 g | Withdrawn |
| Liner B4 | Weight 28.4 g | Withdrawn |
| Dentin i1 | Weight 28.4 g | Withdrawn |
| Dentin Modifier Yellow | Weight 28.4 g | Withdrawn |
| Stain Yellow Ochre | Weight 3 g | Withdrawn |
| Margin Modifiers Yellow-Red | Weight 28.4 g | Withdrawn |
| Opaceous Dentin Shade Series PZ 311 | Weight 28.4 g | Withdrawn |
| Stain Red | Weight 3 g | Withdrawn |
| Dentin i3 | Weight 28.4 g | Withdrawn |
| Margin C1 | Weight 28.4 g | Withdrawn |
| Dentin Shade Series PZ 102 | Weight 28.4 g | Withdrawn |
| Opal Enamel Medium | Weight 28.4 g | Withdrawn |
| Dentin Shade Series PZ 311 | Weight 28.4 g | Withdrawn |
| Stain White | Weight 3 g | Withdrawn |
| Natural Enamel White | Weight 28.4 g | Withdrawn |
| Liner Modifier Tan | Weight 28.4 g | Withdrawn |
| Dentin Modifier B1 | Weight 28.4 g | Withdrawn |
| Dentin A3.5 | Weight 28.4 g | Withdrawn |
| Dentin Modifier Blue | Weight 28.4 g | Withdrawn |
| Opaceous Dentin i1 | Weight 28.4 g | Withdrawn |
| Opaceous Dentin Shade Series PZ 421 | Weight 28.4 g | Withdrawn |
| Liner Shade Series PZ 102 | Weight 28.4 g | Withdrawn |
| Mamelon Yellow Orange | Weight 28.4 g | Withdrawn |
| Stain Chestnut | Weight 3 g | Withdrawn |
| Natural Enamel Ivory | Weight 28.4 g | Withdrawn |
| Liner Shade Series PZ 207 | Weight 28.4 g | Withdrawn |
| Opaceous Dentin Shade Series PZ 423 | Weight 28.4 g | Withdrawn |
| Dentin Shade Series PZ 208 | Weight 28.4 g | Withdrawn |
| Opal Enamel White | Weight 28.4 g | Withdrawn |
| Liner D4 | Weight 28.4 g | Withdrawn |
| Stain Ochre | Weight 3 g | Withdrawn |
| Dentin D4 | Weight 28.4 g | Withdrawn |
| Dentin C2 | Weight 28.4 g | Withdrawn |
| Dentin i5 | Weight 28.4 g | Withdrawn |
| Stain Dove-Blue | Weight 3 g | Withdrawn |
| Opaceous Dentin Shade Series PZ 314 | Weight 28.4 g | Withdrawn |
| Margin illumine | Weight 28.4 g | Withdrawn |
| Add-On Dark Tissue Tint | Weight 28.4 g | Withdrawn |
| Opaceous Dentin Shade Series PZ 420 | Weight 28.4 g | Withdrawn |
| Mamelon Red Orange | Weight 28.4 g | Withdrawn |
| Dentin Shade Series PZ 417 | Weight 28.4 g | Withdrawn |
| Dentin B2 | Weight 28.4 g | Withdrawn |
| Dentin A3 | Weight 28.4 g | Withdrawn |
| Natural Enamel Blue | Weight 28.4 g | Withdrawn |
| Opal Enamel Dark | Weight 28.4 g | Withdrawn |
| Liner Modifier Ochre | Weight 28.4 g | Withdrawn |
| Stain Amber | Weight 3 g | Withdrawn |
| Liner Shade Series PZ 524 | Weight 28.4 g | Withdrawn |
| Opaceous Dentin i5 | Weight 28.4 g | Withdrawn |
| Opaceous Dentin C3 | Weight 28.4 g | Withdrawn |
| Liner B3 | Weight 28.4 g | Withdrawn |
| Liner Shade Series PZ 206 | Weight 28.4 g | Withdrawn |
| Dentin C4 | Weight 28.4 g | Withdrawn |
| Opaceous Dentin Shade Series PZ 418 | Weight 28.4 g | Withdrawn |
| Opaceous Dentin Shade Series PZ 208 | Weight 28.4 g | Withdrawn |
| Liner A1 | Weight 28.4 g | Withdrawn |
| Stain Olive | Weight 3 g | Withdrawn |
| Stain Khaki | Weight 3 g | Withdrawn |
| Opaceous Dentin D2 | Weight 28.4 g | Withdrawn |
| Liner Shade Series PZ 422 | Weight 28.4 g | Withdrawn |
| Stain Blue | Weight 3 g | Withdrawn |
| Liner B1 | Weight 28.4 g | Withdrawn |
| Liner Modifier Pink | Weight 28.4 g | Withdrawn |
| Dentin Shade Series PZ 419 | Weight 28.4 g | Withdrawn |
| Liner A4 | Weight 28.4 g | Withdrawn |
| Dentin Shade Series PZ 421 | Weight 28.4 g | Withdrawn |
| Liner Shade Series PZ 208 | Weight 28.4 g | Withdrawn |
| Dentin Shade Series PZ 101 | Weight 28.4 g | Withdrawn |
| Margin Modifiers Honey-Yellow | Weight 28.4 g | Withdrawn |
| Dentin B4 | Weight 28.4 g | Withdrawn |
| Opaceous Dentin D4 | Weight 28.4 g | Withdrawn |
| Natural Enamel Extra Light | 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.