Dental Device Guide
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Manufacturer registered with FDA

Qinhuangdao Audental Metal Technology Co., Ltd.

Qinhuangdao City, China. Lists 6 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.

FDA owner/operator10054865Manufacturer
Device types listed
6
Brands and models
92
510(k) clearances
12020–2020
Markets registered in
1United States
Establishments
1China
2020: 120102020

510(k) clearances per year, 2007–2026

Devices listed with FDA

What Qinhuangdao Audental Metal Technology Co., Ltd. currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Porcelain PowderEIH · Class 2Dental ceramics & zirconiaMaker
dental zirconia 3d-pro, size:98x10, 98x12, 98x14, 98x16, 98x18,98x20,98x22,98x25,98x30, shade:W,A1,layer:Multi,Singledental zirconia 3d-pro, size:98x10, 98x12, 98x14, 98x16, 98x18,98x20,98x22,98x25,98x30, shade:W,A2,layer:Multi,Singledental zirconia 3d-pro, size:98x10, 98x12, 98x14, 98x16, 98x18,98x20,98x22,98x25,98x30, shade:W,A3,layer:Multi,Singledental zirconia 3d-pro, size:98x10, 98x12, 98x14, 98x16, 98x18,98x20,98x22,98x25,98x30, shade:W,A3.5,layer:Multi,Singledental zirconia 3d-pro, size:98x10, 98x12, 98x14, 98x16, 98x18,98x20,98x22,98x25,98x30, shade:W,A4,layer:Multi,Singledental zirconia 3d-pro,size:98x10,98x12,98x14,98x16, 98x18, 98x20, 98x22, 98x25, 98x30, shade:B1, B2,layer:Multi,Singledental zirconia 3d-pro,size:98x10,98x12,98x14,98x16, 98x18, 98x20, 98x22, 98x25, 98x30, shade:B3, B4,layer:Multi,Single;dental zirconia 3d-pro,size:98x10,98x12,98x14,98x16, 98x18, 98x20, 98x22, 98x25, 98x30, shade:BL1, BL2,layer:Multi,Singldental zirconia 3d-pro,size:98x10,98x12,98x14,98x16, 98x18, 98x20, 98x22, 98x25, 98x30, shade:C1, C2,layer:Multi,Single;dental zirconia 3d-pro,size:98x10,98x12,98x14,98x16, 98x18, 98x20, 98x22, 98x25, 98x30, shade:C3, C4,layer:Multi,Single;
56 more
dental zirconia 3d-pro,size:98x10,98x12,98x14,98x16, 98x18, 98x20, 98x22, 98x25, 98x30, shade:D2, D3,layer:Multi,Single;dental zirconia 3d-pro,size:98x10,98x12,98x14,98x16, 98x18, 98x20, 98x22, 98x25, 98x30, shade:D4,layer:Multi,Single;dental zirconia 3d-pro,size:98x10,98x12,98x14,98x16, 98x18, 98x20, 98x22, 98x25,98x30,shade:BL3, BL4,layer:Multi,Singledental zirconia HT, size:98x10,98x12,98x14,98x16,98x18,98x20,98x22, 98x25, 98x30, shade: B1, B2,layer:Multi,Single;dental zirconia HT, size:98x10,98x12,98x14,98x16,98x18,98x20,98x22, 98x25, 98x30, shade: B3, B4,layer:Multi,Single;dental zirconia HT, size:98x10,98x12,98x14,98x16,98x18,98x20,98x22, 98x25, 98x30, shade: BL1, BL2,layer:Multi,Single;dental zirconia HT, size:98x10,98x12,98x14,98x16,98x18,98x20,98x22, 98x25, 98x30, shade: BL3, BL4,layer:Multi,Single;dental zirconia HT, size:98x10,98x12,98x14,98x16,98x18,98x20,98x22, 98x25, 98x30, shade: C1, C2,layer:Multi,Single;dental zirconia HT, size:98x10,98x12,98x14,98x16,98x18,98x20,98x22, 98x25, 98x30, shade: C3, C4,layer:Multi,Single;dental zirconia HT, size:98x10,98x12,98x14,98x16,98x18,98x20,98x22, 98x25, 98x30, shade: D2, D3,layer:Multi,Single;dental zirconia HT, size:98x10,98x12,98x14,98x16,98x18,98x20,98x22, 98x25, 98x30, shade: D4,layer:Multi,Single;dental zirconia HT, size:98x10,98x12,98x14,98x16,98x18,98x20,98x22, 98x25, 98x30, shade: W, A1, A2, layer:Multi,Single;dental zirconia HT, size:98x10,98x12,98x14,98x16,98x18,98x20,98x22, 98x25, 98x30, shade: W, A3,A3.5,layer:Multi,Single;dental zirconia HT, size:98x10,98x12,98x14,98x16,98x18,98x20,98x22, 98x25, 98x30, shade: W, A4,layer:Multi,Single;dental zirconia st-size:98x10, 98x12, 98x14, 98x16, 98x18, 98x20, 98x22, 98x25, 98x30, shade:W,A1, A2,layer:Multi,Singledental zirconia st-size:98x10, 98x12, 98x14, 98x16, 98x18, 98x20, 98x22, 98x25, 98x30, shade:W,A3,layer:Multi,Singledental zirconia st-size:98x10, 98x12, 98x14, 98x16, 98x18, 98x20, 98x22, 98x25, 98x30,shade:W,A3.5,A4,layer:Multi,Singledental zirconia ST, size:98x10, 98x12, 98x14, 98x16, 98x18, 98x20, 98x22, 98x25, 98x30, shade:B1, B2,layer:Multi,Singledental zirconia ST, size:98x10, 98x12, 98x14, 98x16, 98x18, 98x20, 98x22, 98x25, 98x30, shade:B3, B4,layer:Multi,Single;dental zirconia ST, size:98x10, 98x12, 98x14, 98x16, 98x18, 98x20, 98x22, 98x25, 98x30, shade:BL1, BL2,layer:Multi,Singldental zirconia ST, size:98x10, 98x12, 98x14, 98x16, 98x18, 98x20, 98x22, 98x25, 98x30, shade:C1, C2,layer:Multi,Single;dental zirconia ST, size:98x10, 98x12, 98x14, 98x16, 98x18, 98x20, 98x22, 98x25, 98x30, shade:C3, C4,layer:Multi,Single;dental zirconia ST, size:98x10, 98x12, 98x14, 98x16, 98x18, 98x20, 98x22, 98x25, 98x30, shade:D2, D3,layer:Multi,Single;dental zirconia ST, size:98x10, 98x12, 98x14, 98x16, 98x18, 98x20, 98x22, 98x25, 98x30, shade:D4,layer:Multi,Single;dental zirconia ST, size:98x10,98x12,98x14,98x16,98x18, 98x20, 98x22, 98x25, 98x30, shade:BL3, BL4,layer:Multi,Singledental zirconia ST+, size: C17 shade: B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, D4,layer: Multi,Single;dental zirconia ST+, size: C17 shade: W, BL1, BL2, BL3, BL4, A1, A2, A3, A3.5, A4,layer: Multi,Single;dental zirconia ST+, size:98x10, 98x12, 98x14, 98x16, 98x18, 98x20, 98x22,98x25,98x30,shade:W,A1, A2,layer:Multi,Singledental zirconia ST+, size:98x10,98x12,98x14,98x16,98x18, 98x20, 98x22, 98x25, 98x30, shade:B1, B2,layer:Multi,Single;dental zirconia ST+, size:98x10,98x12,98x14,98x16,98x18, 98x20, 98x22, 98x25, 98x30, shade:B3, B4,layer:Multi,Single;dental zirconia ST+, size:98x10,98x12,98x14,98x16,98x18, 98x20, 98x22, 98x25, 98x30, shade:BL1, BL2,layer:Multi,Single;dental zirconia ST+, size:98x10,98x12,98x14,98x16,98x18, 98x20, 98x22, 98x25, 98x30, shade:BL3, BL4,layer:Multi,Single;dental zirconia ST+, size:98x10,98x12,98x14,98x16,98x18, 98x20, 98x22, 98x25, 98x30, shade:C1, C2,layer:Multi,Single;dental zirconia ST+, size:98x10,98x12,98x14,98x16,98x18, 98x20, 98x22, 98x25, 98x30, shade:C3, C4,layer:Multi,Single;dental zirconia ST+, size:98x10,98x12,98x14,98x16,98x18, 98x20, 98x22, 98x25, 98x30, shade:D2, D3,layer:Multi,Single;dental zirconia ST+, size:98x10,98x12,98x14,98x16,98x18, 98x20, 98x22, 98x25, 98x30, shade:D4,layer:Multi,Single;dental zirconia ST+, size:98x10,98x12,98x14,98x16,98x18, 98x20, 98x22, 98x25, 98x30, shade:W, A4,layer:Multi,Single;dental zirconia ST+, size:98x10,98x12,98x14,98x16,98x18, 98x20, 98x22, 98x25, 98x30, shade:W,A3,A3.5,layer:Multi,Single;dental zirconia UT, size:98x10, 98x12,98x14,98x16,98x18,98x20, 98x22, 98x25, 98x30, shade:W, A1, A2,layer:Multi,Single;dental zirconia UT, size:98x10, 98x12,98x14,98x16,98x18,98x20, 98x22, 98x25, 98x30, shade:W, A3,A3.5,layer:Multi,Single;dental zirconia UT, size:98x10,98x12,98x14,98x16, 98x18, 98x20, 98x22, 98x25, 98x30, shade:BL1, BL2,layer:Multi,Single;dental zirconia UT, size:98x10,98x12,98x14,98x16, 98x18, 98x20, 98x22, 98x25, 98x30, shade:BL3, BL4,layer:Multi,Single;dental zirconia UT, size:98x10,98x12,98x14,98x16,98x18, 98x20, 98x22, 98x25, 98x30, shade:B1, B2,layer:Multi,Single;dental zirconia UT, size:98x10,98x12,98x14,98x16,98x18, 98x20, 98x22, 98x25, 98x30, shade:B3, B4,layer:Multi,Single;dental zirconia UT, size:98x10,98x12,98x14,98x16,98x18, 98x20, 98x22, 98x25, 98x30, shade:C1, C2,layer:Multi,Single;dental zirconia UT, size:98x10,98x12,98x14,98x16,98x18, 98x20, 98x22, 98x25, 98x30, shade:C3, C4,layer:Multi,Single;dental zirconia UT, size:98x10,98x12,98x14,98x16,98x18, 98x20, 98x22, 98x25, 98x30, shade:D2, D3,layer:Multi,Single;dental zirconia UT, size:98x10,98x12,98x14,98x16,98x18, 98x20, 98x22, 98x25, 98x30, shade:D4,layer:Multi,Single;dental zirconia UT, size:98x10,98x12,98x14,98x16,98x18, 98x20, 98x22, 98x25, 98x30, shade:W,A4,layer:Multi,Single;HENZIR Dental ZIRCONIA 3d-pro, size:98x10, 98x12, 98x14, 98x16, 98x18, 98x20, 98x22, 98x25, 98x30, shade: A1, A2, A3HENZIR Dental ZIRCONIA 3d-pro, size:98x10, 98x12, 98x14, 98x16, 98x18, 98x20, 98x22, 98x25, 98x30, shade: A3.5, A4, B1HENZIR Dental ZIRCONIA 3d-pro, size:98x10, 98x12, 98x14, 98x16, 98x18, 98x20, 98x22, 98x25, 98x30, shade: B2, B3, B4HENZIR Dental ZIRCONIA 3d-pro, size:98x10, 98x12, 98x14, 98x16, 98x18, 98x20, 98x22, 98x25, 98x30, shade: C1, C2, C3HENZIR Dental ZIRCONIA 3d-pro, size:98x10, 98x12, 98x14, 98x16, 98x18, 98x20, 98x22, 98x25, 98x30, shade: C4, D2, D3HENZIR Dental ZIRCONIA 3d-pro, size:98x10, 98x12, 98x14, 98x16, 98x18, 98x20, 98x22, 98x25, 98x30, shade:BL3, BI4;HENZIR Dental ZIRCONIA 3d-pro, size:98x10, 98x12, 98x14, 98x16, 98x18, 98x20, 98x22, 98x25, 98x30, shade:D4, BL1, BL2
2023
Base Metal AlloyEJH · Class 2Dental alloysMaker
Audental Cobalt H SLM PowerAudental Cobalt SLM powder; Audental Ultra SLM powder; Audental Ti SLM powder; Audental TC4 SLM powderAudental Pt15;Audental 43-;Audental Bond;Audental Pd25;Audental Cobalt; Audental Cobalt H;Audental Ti; Audental TC4Audental Ultra; Audental Ultra H; Audental Excel; Audental Excel+; Audental PlusHENZIR COBALT HHENZIR TC4HENZIR TC4 SLM POWDERSpace Ti
2017
Alloy Other Noble MetalEJS · Class 2Dental alloysMaker
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 Pd70;Audental Pd71;Audental Pd61;Audental Pd58;Audental Pd55;Audental Pd50;Audental Pt15Audental Pt20
2017
Gold-Based Noble Metal AlloyEJT · Class 2Dental alloysMaker
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 U60Audental 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;HENZIR 40HENZIR A60
2017
Denture Preformed (Partially Prefabricated Denture)EKO · Class 2Denture resins & teethMaker
DENTURE PREFORMED (PARTIALLY PREFABRICATEDDENTURE
2026
Preformed CrownELZ · Class 1—Maker
CROWN, PREFORMED
2026

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names Qinhuangdao Audental Metal Technology Co., Ltd. as the applicant.

Decided510(k)DeviceDevice type
31 Jan 2020K192535Unshaded Dental Zirconia and Pre-Shaded Dental ZirconiaEIH Porcelain Powder

Registered establishments

EstablishmentLocationWhat it does
Qinhuangdao Audental Metal Technology Co., Ltd.FDA reg. 3013546336Qinhuangdao City Hebei, ChinaManufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10054865). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.