Data / Medical devices / China / Qinhuangdao Audental Metal Technology Co., Ltd.
Qinhuangdao Audental Metal Technology Co., Ltd.: FDA-registered device maker in Qinhuangdao City Hebei, China, 1 510(k) clearance
Qinhuangdao Audental Metal Technology Co., Ltd. is registered with the FDA (registration 3013546336) in Qinhuangdao City Hebei, China. It lists 11 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 31, 2020. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3013546336
- Address
- Floor 2, 16 North D, 1 Yanghe Road, Development Area, Qinhuangdao City Hebei, China, 066004
- Owner or operator
- Qinhuangdao Audental Metal Technology Co., Ltd. (10054865)
- Roles
- Manufacturer
- First device listed
- May 5, 2017
- Registered through
- 2027
- Brand names listed
- Audental 15; Audental 40+; Audental 30;Audental 35; Audental 43;Audental 02;Audental 54;Audental 61;, Audental 40A;Audental A52;Audental A6;Audental A62;Audental A83;Audental A77;Audental A75;, Audental 75+;Audental 65;Audental 62;Audental 54;Audental 52;Audental 52+;Audental 45;, Audental 90;Audental 86;Audental 74 ;Audental 50; Audental 03; Audental 04;Audental 22; Audental 40;, Audental 98;Audental 89;Audental 86+; Audental 87;Audental 86A;Audental 84;Audental 76;Audental 75;, Audental A42;Audental U75;Audental U73;Audental U55;Audental U60, Audental A60+;Audental A56;Audental A50+;Audental A52+;Audental A50B;Audental A50C;, Audental A63;Audental A60;Audental A58;Audental A50;Audental A46;Audental A41;Audental A68; and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Alloy, Gold-Based Noble Metal | EJT | 2 | Manufacturer | accessdata.fda.gov |
| Alloy, Metal, Base | EJH | 2 | Manufacturer | accessdata.fda.gov |
| Alloy, Other Noble Metal | EJS | 2 | Manufacturer | accessdata.fda.gov |
| Crown, Preformed | ELZ | 1 | Manufacturer | accessdata.fda.gov |
| Denture Preformed (Partially Prefabricated Denture) | EKO | 2 | Manufacturer | accessdata.fda.gov |
| Dentures, Partial | NSK | N | Manufacturer | accessdata.fda.gov |
| Powder, Porcelain | EIH | 2 | Manufacturer | accessdata.fda.gov |
| Restoration, Base Metal | NSQ | N | Manufacturer | accessdata.fda.gov |
| Restoration, Noble Metal | NSJ | N | Manufacturer | accessdata.fda.gov |
| Restoration, Porcelain | NSP | N | Manufacturer | accessdata.fda.gov |
| Restoration, Porcelain-Fused-To-Metal | NSO | N | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 31, 2020 | K192535 | Unshaded Dental Zirconia and Pre-Shaded Dental Zirconia | EIH | Substantially Equivalent | Qinhuangdao Audental Metal Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Powder, Porcelain
- All makers of Alloy, Other Noble Metal
- All makers of Denture Preformed (Partially Prefabricated Denture)
- All makers of Restoration, Noble Metal
- All makers of Dentures, Partial
- All makers of Restoration, Porcelain-Fused-To-Metal
Updated January 31, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.