Qinhuangdao Audental Metal Technology Co., Ltd.
Registered establishment in Qinhuangdao, Hebei, China. 11 device types, 1 clearance.
Qinhuangdao Audental Metal Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Crown, Preformed, Dentures, Partial and 9 other device types. Its earliest product listing with the FDA dates from 2017.
11device types registered with the FDA
1510(k) clearance
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3013546336 |
| FEI number | 3013546336 |
| Establishment type | Manufacturer |
Location
| City | Qinhuangdao |
|---|---|
| Province | Hebei |
| Address | Floor 2, 16 North D, 1 Yanghe Road, Development Area |
| Postal code | 066004 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Alloy, Gold-Based Noble Metal | Class 2 | Henzir 40, Henzir A60, Audental A42;Audental U75;Audental U73;Audental U55;Audental U60, Audental A63;Audental A60;Audental A58;Audental A50;Audental A46;Audental A41;Audental A68;, Audental 40A;Audental A52;Audental A6;Audental A62;Audental A83;Audental A77;Audental A75;, Audental A60+;Audental A56;Audental A50+;Audental A52+;Audental A50B;Audental A50C; and 3 more | 2017 | 11 |
| Alloy, Metal, Base | Class 2 | Henzir TC4 SLM Powder, Audental Ultra; Audental Ultra H; Audental Excel; Audental Excel+; Audental Plus, Audental Pt15;Audental 43-;Audental Bond;Audental Pd25;Audental Cobalt; Audental Cobalt H;, Audental Ti; Audental TC4, Audental Cobalt SLM powder; Audental Ultra SLM powder; Audental Ti SLM powder; Audental TC4 SLM powder, Henzir TC4 and 3 more | 2017 | 24 |
| Alloy, Other Noble Metal | Class 2 | Audental Pd70;Audental Pd71;Audental Pd61;Audental Pd58;Audental Pd55;Audental Pd50;, Audental 15; Audental 40+; Audental 30;Audental 35; Audental 43;Audental 02;Audental 54;Audental 61;, Audental Pal;Audental Pal 2;Audental 60;Audental Pd80;Audental Pd80+;Audental Pd76;Audental Pd75;, Audental Pd49;Audental A10;Audental A20;Audental A35;Audental A25;Audental A25+;Audental U40;Audental 43+;, Audental Pt20, Audental Pt15 | 2017 | 12 |
| Crown, Preformed | Class 1 | Crown, Preformed | 2026 | 23 |
| Denture Preformed (Partially Prefabricated Denture) | Class 2 | Denture Preformed (Partially Prefabricateddenture | 2026 | 7 |
| Dentures, Partial | Class N | Flexible Denture; Partial Denture; Removable Partial Denture | 2026 | 55 |
| Powder, Porcelain | Class 2 | dental zirconia UT, size:98×10,98×12,98×14,98×16,98×18, 98×20, 98×22, 98×25, 98×30, shade:D2, D3,layer:Multi,Single;, dental zirconia ST, size:98×10, 98×12, 98×14, 98×16, 98×18, 98×20, 98×22, 98×25, 98×30, shade:B3, B4,layer:Multi,Single;, dental zirconia 3d-pro,size:98×10,98×12,98×14,98×16, 98×18, 98×20, 98×22, 98×25, 98×30, shade:B3, B4,layer:Multi,Single;, dental zirconia ST, size:98×10, 98×12, 98×14, 98×16, 98×18, 98×20, 98×22, 98×25, 98×30, shade:C3, C4,layer:Multi,Single;, dental zirconia ST+, size:98×10,98×12,98×14,98×16,98×18, 98×20, 98×22, 98×25, 98×30, shade:W, A4,layer:Multi,Single;, HENZIR Dental ZIRCONIA 3d-pro, size:98×10, 98×12, 98×14, 98×16, 98×18, 98×20, 98×22, 98×25, 98×30, shade: B2, B3, B4 and 47 more | 2023 | 33 |
| Restoration, Base Metal | Class N | Metal Restoration (Base Metal) | 2026 | 43 |
| Restoration, Noble Metal | Class N | Metal Restoration (Noble Metal / Semi Precious Metal/ Base Metal) | 2026 | 42 |
| Restoration, Porcelain | Class N | EMAX Crown / Bridge; Full Ceramic Restoration; Porcelain Restoration; Zirconia Crown / Bridge | 2026 | 50 |
| Restoration, Porcelain-Fused-To-Metal | Class N | Porcelain Fused to Metal Restoration | 2026 | 50 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K192535 | 2020-01-31 | EIH | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2007 |
|---|---|
| Employees | 80-100 |
| Main products | Dental zirconia blocks, Glass ceramics, Dental metal alloys, PMMA blocks, Dental lab equipment |
| Certifications | ISO 13485, CE 0197, FDA, CFDA (NMPA), TUV |
| Export markets | North America, South America, Western Europe, Eastern Europe, Eastern Asia, Southeast Asia, Middle East, Africa, Oceania |
| OEM and ODM | Offered |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Contec Medical Systems Co., Ltd. | 22 |
| Aidite (Qinhuangdao) Technology Co., Ltd. | 17 |
| Qinhuangdao Taizhi Medical Technology Co., Ltd. | 5 |
| Qinhuangdao Huisianpu Medical Systems Inc. | 4 |
| Qinhuangdao Kapunuomaite Medical Equipment S&T Co., Ltd. | 3 |
| Qinhuangdao Silide Ceramic Technology Co., Ltd. | 1 |
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.
The manufacturer named here can complete this record.