Celtra® Ceram
Celtra Ceram Enamel Opal - EO1, Extra-light, 50G
33manufacturers in China registered for this device type
84catalogue 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 | 2019-03-15 |
| Record revised | 2024-11-22 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Sizes | Weight 15 to 50 g |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Dentin 208 | Weight 15 g | In distribution |
| 650202 | In distribution | |
| Dentin 209 | Weight 15 g | In distribution |
| Dentin 310 | Weight 50 g | In distribution |
| Dentin 315 | Weight 50 g | In distribution |
| Dentin 420 | Weight 15 g | In distribution |
| 650211 | In distribution | |
| 650149 | In distribution | |
| 650137 | In distribution | |
| 650206 | In distribution | |
| Dentin 101 | Weight 50 g | In distribution |
| 650133 | In distribution | |
| Dentin 203 | Weight 15 g | In distribution |
| Dentin 524 | Weight 50 g | In distribution |
| 650140 | In distribution | |
| Dentin 420 | Weight 50 g | In distribution |
| Dentin 423 | Weight 50 g | In distribution |
| 650141 | In distribution | |
| Dentin 422 | Weight 50 g | In distribution |
| 650146 | In distribution | |
| Dentin 204 | Weight 50 g | In distribution |
| Dentin 417 | Weight 15 g | In distribution |
| 650135 | In distribution | |
| Dentin 207 | Weight 50 g | In distribution |
| 650213 | In distribution | |
| Dentin 203 | Weight 50 g | In distribution |
| Dentin 418 | Weight 15 g | In distribution |
| Dentin 314 | Weight 50 g | In distribution |
| Dentin 316 | Weight 50 g | In distribution |
| Dentin 310 | Weight 15 g | In distribution |
| Dentin 204 | Weight 15 g | In distribution |
| Dentin 421 | Weight 50 g | In distribution |
| Dentin 312 | Weight 50 g | In distribution |
| Dentin 417 | Weight 50 g | In distribution |
| 650205 | In distribution | |
| 650214 | In distribution | |
| 650142 | In distribution | |
| 650216 | In distribution | |
| Dentin 102 | Weight 15 g | In distribution |
| Dentin 525 | Weight 50 g | In distribution |
| 650138 | In distribution | |
| Dentin 313 | Weight 15 g | In distribution |
| Dentin 205 | Weight 50 g | In distribution |
| Dentin 101 | Weight 15 g | In distribution |
| 650143 | In distribution | |
| 650145 | In distribution | |
| Dentin 422 | Weight 15 g | In distribution |
| 650148 | In distribution | |
| Dentin 206 | Weight 15 g | In distribution |
| 650139 | In distribution | |
| 650212 | In distribution | |
| 650134 | In distribution | |
| Dentin 209 | Weight 50 g | In distribution |
| 650132 | In distribution | |
| Dentin 423 | Weight 15 g | In distribution |
| 650201 | In distribution | |
| 650136 | In distribution | |
| 650203 | In distribution | |
| Dentin 421 | Weight 15 g | In distribution |
| 650204 | In distribution | |
| Dentin 525 | Weight 15 g | In distribution |
| Dentin 206 | Weight 50 g | In distribution |
| 650130 | In distribution | |
| Dentin 418 | Weight 50 g | In distribution |
| Dentin 311 | Weight 15 g | In distribution |
| Dentin 419 | Weight 15 g | In distribution |
| Dentin 314 | Weight 15 g | In distribution |
| Dentin 208 | Weight 50 g | In distribution |
| Dentin 316 | Weight 15 g | In distribution |
| Dentin 526 | Weight 50 g | In distribution |
| Dentin 313 | Weight 50 g | In distribution |
| Dentin 311 | Weight 50 g | In distribution |
| Dentin 419 | Weight 50 g | In distribution |
| Dentin 315 | Weight 15 g | In distribution |
| 650147 | In distribution | |
| Dentin 524 | Weight 15 g | In distribution |
| 650131 | In distribution | |
| Dentin 205 | Weight 15 g | In distribution |
| 650215 | In distribution | |
| Dentin 312 | Weight 15 g | In distribution |
| 650144 | In distribution | |
| Dentin 102 | Weight 50 g | In distribution |
| Dentin 526 | Weight 15 g | In distribution |
| Dentin 207 | Weight 15 g | 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 |
|---|---|
| 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.