Luminesse Zirconia Discs
95 x 10 mm
33manufacturers in China registered for this device type
355catalogue numbers in this listing
5510(k) clearances naming this product code
1recall
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 | Talladium, Inc., United States |
|---|---|
| FDA product code | EIH |
| Device type | Powder, Porcelain |
| Device class | Class 2 |
| Regulation | 21 CFR 872.6660 |
| Establishment | Manufacturer |
| 510(k) | K152066 |
| Record published | 2016-10-24 |
| Record revised | 2024-12-30 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5143D4 | In distribution | |
| 5147D3 | In distribution | |
| 5143A35 | In distribution | |
| 5185HS | In distribution | |
| 5144-B4 | In distribution | |
| 5148C1 | In distribution | |
| 5143NRT | In distribution | |
| 5145T | In distribution | |
| 5143A2 | In distribution | |
| 5146MLB1HT | In distribution | |
| 5174T | In distribution | |
| 5147C2 | In distribution | |
| 19520-OFA | In distribution | |
| 19820-OFAML-B3 | In distribution | |
| 19820-OFA | In distribution | |
| 5164ATV5 | In distribution | |
| 5147ATW | In distribution | |
| 5082 | In distribution | |
| 5147NR | In distribution | |
| 5144D3 | In distribution | |
| 5081MLB1HT | In distribution | |
| 19816-ATML-B2 | In distribution | |
| 19816-OFAML-B1 | In distribution | |
| 5135-C2 | In distribution | |
| 5081MLA3A35HT | In distribution | |
| 5147A35 | In distribution | |
| 5139T | In distribution | |
| 19512-OFA | In distribution | |
| 5147A1 | In distribution | |
| 5164ATV1 | In distribution | |
| 5172 | In distribution | |
| 5113 | In distribution | |
| 5174-HS | In distribution | |
| 5146NR | In distribution | |
| 5145ATV4 | In distribution | |
| 19816-OFAML-B3 | In distribution | |
| 5174 | In distribution | |
| 5165AT | In distribution | |
| 19814-ATML-A2 | In distribution | |
| 5165ATV2 | In distribution | |
| 5180HTT | In distribution | |
| 19814-OFAML-C3 | In distribution | |
| 5142T | In distribution | |
| 6849-A3.5 | In distribution | |
| 19814-ATML-C1 | In distribution | |
| 5143C4 | In distribution | |
| 5142AT | In distribution | |
| 5081MLA3HT | In distribution | |
| 19818-OFA | In distribution | |
| 5135T | In distribution | |
| 5126 | In distribution | |
| 5144ATV5 | In distribution | |
| 5144A1 | In distribution | |
| 5186HS | In distribution | |
| 6850-C2 | In distribution | |
| 5179HS | In distribution | |
| 5148A1 | In distribution | |
| 5171T | In distribution | |
| 5114 | In distribution | |
| 5081MLBLEACHHT | In distribution | |
| 5147-MLAT-A1 | In distribution | |
| 19816-ATML-C3 | In distribution | |
| 6850-A3.5 | In distribution | |
| 19814-ATML-A2 | In distribution | |
| 5145ATV3 | In distribution | |
| 6850-B2 | In distribution | |
| 5164AT | In distribution | |
| 5143D2 | In distribution | |
| 19816-OFAML-A2 | In distribution | |
| 5171ATV4 | In distribution | |
| 5145NR | In distribution | |
| 5147ATV5 | In distribution | |
| 5143ATV2 | In distribution | |
| 5145-B2 | In distribution | |
| 5146MLA1A2HT | In distribution | |
| 5048 | In distribution | |
| 5180HS | In distribution | |
| 5144-MLAT-B1 | In distribution | |
| 5146MLC1HT | In distribution | |
| 5141T | In distribution | |
| 5164ATV4 | In distribution | |
| 5147A3 | In distribution | |
| 5144AT | In distribution | |
| 5147B4 | In distribution | |
| 5147ATV4 | In distribution | |
| 5147AT | In distribution | |
| 5148A3 | In distribution | |
| 19814-OFAML-A1 | In distribution | |
| 5164HTT | In distribution | |
| 5148B3 | In distribution | |
| 5148NRT | In distribution | |
| 5148A35 | In distribution | |
| 5147AD | In distribution | |
| 5145ATV2 | In distribution | |
| 19814-OFAML-C2 | In distribution | |
| 19814-OFA | In distribution | |
| 5110 | In distribution | |
| 5175ATV4 | In distribution | |
| 5147A2 | In distribution | |
| 5143D3 | In distribution | |
| 6850-A3 | In distribution | |
| 5144ATW | In distribution | |
| 5166 | In distribution | |
| 5144MLA3A35HT | In distribution | |
| 19814-ATML-D2 | In distribution | |
| 5112 | In distribution | |
| 6849-C2 | In distribution | |
| 19516-OFA | In distribution | |
| 5144NRT | In distribution | |
| 5175T | In distribution | |
| 5164ATV3 | In distribution | |
| 5144-MLAT-A3 | In distribution | |
| 5143NR | In distribution | |
| 5146MLB1B2HT | In distribution | |
| 19816-OFAML-C2 | In distribution | |
| 5179AT | In distribution | |
| 5145ATV5 | In distribution | |
| 5164 | In distribution | |
| 5179HT | In distribution | |
| 19816-ATML-A1 | In distribution | |
| 5145NRT | In distribution | |
| 5081MLA1A2HT | In distribution | |
| 5127 | In distribution | |
| 19530-OFA | In distribution | |
| 5172HT | In distribution | |
| 5148B4 | In distribution | |
| 5145-A3.5 | In distribution | |
| 5175ATV1 | In distribution | |
| 5148C4 | In distribution | |
| 5146MLA1HT | In distribution | |
| 5170HS | In distribution | |
| 5168T | In distribution | |
| 5148D4 | In distribution | |
| 5147C4 | In distribution | |
| 5144D4 | In distribution | |
| 5147A4 | In distribution | |
| 5081MLC1HT | In distribution | |
| 19816-ATML-B1 | In distribution | |
| 5140T | In distribution | |
| 19820-OFAML-A2 | In distribution | |
| 19816-ATML-C1 | In distribution | |
| 5166-HS | In distribution | |
| 5148T | In distribution | |
| 5175ATV5 | In distribution | |
| 19816-OFAML-C1 | In distribution | |
| 19814-OFAML-C1 | In distribution | |
| 19820-OFAML-C2 | In distribution | |
| 5144MLC1C2HT | In distribution | |
| 6850-A2 | In distribution | |
| 19820-OFAML-A1 | In distribution | |
| 19816-OFAML-B2 | In distribution | |
| 19814-OFAML-D2 | In distribution | |
| 5143ATV4 | In distribution | |
| 5143A3 | In distribution | |
| 5147B1 | In distribution | |
| 19820-OFAML-B2 | In distribution | |
| 5146NRT | In distribution | |
| 5147B2 | In distribution | |
| 19814-ATML-B1 | In distribution | |
| 19820-OFAML-C1 | In distribution | |
| 5148AT | In distribution | |
| 5144MLA1A2HT | In distribution | |
| 5178HT | In distribution | |
| 5143AT | In distribution | |
| 5186HTT | In distribution | |
| 5143C3 | In distribution | |
| 19814-ATML-B2 | In distribution | |
| 19816-OFAML-C3 | In distribution | |
| 5146-A4 | In distribution | |
| 5146-AD | In distribution | |
| 5143ATW | In distribution | |
| 5143B4 | In distribution | |
| 5178HS | In distribution | |
| 5145AT | In distribution | |
| 5143ATV1 | In distribution | |
| 5145-B4 | In distribution | |
| 5144D2 | In distribution | |
| 5144MLD2HT | In distribution | |
| 19510-OFA | In distribution | |
| 5144C2 | In distribution | |
| 19820-OFAML-A3 | In distribution | |
| 5166-HT | In distribution | |
| 5186HT | In distribution | |
| 5165ATV5 | In distribution | |
| 5185HT | In distribution | |
| 5172T | In distribution | |
| 5130 | In distribution | |
| 5129 | In distribution | |
| 5144ATV3 | In distribution | |
| 6849-B1 | In distribution | |
| 5143B3 | In distribution | |
| 5176 | In distribution | |
| 5146T | In distribution | |
| 5148D2 | In distribution | |
| 19820-ATML-B2 | In distribution | |
| 19816-OFAML-A1 | In distribution | |
| 5181HS | In distribution | |
| 5147D2 | In distribution | |
| 5081MLC1C2HT | In distribution | |
| 5143B1 | In distribution | |
| 5183HS | In distribution | |
| 19814-ATML-A3 | In distribution | |
| 5146MLA3HT | In distribution | |
| 5165T | In distribution | |
| 5082-T | In distribution | |
| 5164ATV2 | In distribution | |
| 6849-A2 | In distribution | |
| 5146MLBLEACHHT | In distribution | |
| 5144AD | In distribution | |
| 5147NRT | In distribution | |
| 5181HTT | In distribution | |
| 5145-A4 | In distribution | |
| 5147ATV1 | In distribution | |
| 19816-OFAML-D2 | In distribution | |
| 5178HTT | In distribution | |
| 5180AT | In distribution | |
| 19816-OFAML-A3.5 | In distribution | |
| 5170AT | In distribution | |
| 5148NR | In distribution | |
| 5107 | In distribution | |
| 5171ATV2 | In distribution | |
| 5183AT | In distribution | |
| 5167T | In distribution | |
| 5145-AD | In distribution | |
| 5144C1 | In distribution | |
| 5171ATV3 | In distribution | |
| 5171AT | In distribution | |
| 5182HT | In distribution | |
| 5183HTT | In distribution | |
| 5181AT | In distribution | |
| 5147C1 | In distribution | |
| 5166AT | In distribution | |
| 5144-NR | In distribution | |
| 5144MLBLEACHHT | In distribution | |
| 6849-B2 | In distribution | |
| 5165ATV3 | In distribution | |
| 5144A2 | In distribution | |
| 5126NR | In distribution | |
| 5143AD | In distribution | |
| 19814-OFAML-B1 | In distribution | |
| 5147B3 | In distribution | |
| 5144ATV4 | In distribution | |
| 5147D4 | In distribution | |
| 5144C4 | In distribution | |
| 19830-OFA | In distribution | |
| 5182AT | In distribution | |
| 6849-A1 | In distribution | |
| 5135-A4 | In distribution | |
| 5144ATV2 | In distribution | |
| 5185AT | 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 |
|---|---|
| K152023 | 2016-09-15 |
| K152066 | 2015-10-21 |
| K143090 | 2015-06-15 |
| K140848 | 2014-12-17 |
| K100232 | 2010-05-21 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2020-08-06 | Class II | Under Investigation by firm | The linear shrinkage on the zirconia blank disc s part label is incorrect. The average linear shrinkage found on the product label was outside the acceptable range. The acceptable average linear shrinkage ranges between 1.225 to 1.275. The | 39 pieces | 2022-10-07 |
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.