Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013546336

FEI Number

3013546336

Entity Name

Qinhuangdao Audental Metal Technology Co., Ltd.

City/State/Country

Qinhuangdao City Hebei, CN

Establishment Address

Floor 2, 16 North D, 1 Yanghe Road, Development Area, Qinhuangdao City Hebei 066004, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Qinhuangdao Audental Metal Technology Co., Ltd. (Owner Number: 10054865)

Owner / Operator Contact Address

Floor 2, 16 North D, 1 Yanghe Road, Development Area, Qinhuangdao City, CN-HE 066004, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K192535

PMA Number

N/A

All Registered Proprietary Names

Audental Pt15;Audental 43-;Audental Bond;Audental Pd25;Audental Cobalt; Audental Cobalt H; Audental Ultra; Audental Ultra H; Audental Excel; Audental Excel+; Audental Plus Audental Ti; Audental TC4 Audental Cobalt SLM powder; Audental Ultra SLM powder; Audental Ti SLM powder; Audental TC4 SLM powder Space Ti HENZIR COBALT H HENZIR TC4 HENZIR TC4 SLM POWDER Audental Cobalt H SLM Power dental 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: W, A1, A2, layer:Multi,Single; dental zirconia 3d-pro,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:BL1, BL2,layer:Multi,Singl dental zirconia HT, 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:W,A4,layer:Multi,Single HENZIR Dental ZIRCONIA 3d-pro, size:98x10, 98x12, 98x14, 98x16, 98x18, 98x20, 98x22, 98x25, 98x30, shade:D4, BL1, BL2 HENZIR Dental ZIRCONIA 3d-pro, size:98x10, 98x12, 98x14, 98x16, 98x18, 98x20, 98x22, 98x25, 98x30, shade: B2, B3, B4 HENZIR 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: A1, A2, A3 HENZIR Dental ZIRCONIA 3d-pro, size:98x10, 98x12, 98x14, 98x16, 98x18, 98x20, 98x22, 98x25, 98x30, shade: C4, D2, D3 dental zirconia ST+, size: C17 shade: W, BL1, BL2, BL3, BL4, A1, A2, A3, A3.5, A4,layer: Multi,Single; dental zirconia ST+, size: C17 shade: B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, D4,layer: Multi,Single; dental zirconia st-size:98x10, 98x12, 98x14, 98x16, 98x18, 98x20, 98x22, 98x25, 98x30, shade:W,A1, A2,layer:Multi,Single dental zirconia 3d-pro, size:98x10, 98x12, 98x14, 98x16, 98x18,98x20,98x22,98x25,98x30, shade:W,A1,layer:Multi,Single dental zirconia HT, size:98x10,98x12,98x14,98x16,98x18,98x20,98x22, 98x25, 98x30, shade: W, A4,layer:Multi,Single; dental zirconia 3d-pro,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:BL1, BL2,layer:Multi,Single; dental zirconia UT, 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:W,A3.5,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:W, A4,layer:Multi,Single; dental zirconia UT, 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:W,A3.5,A4,layer:Multi,Single dental zirconia HT, size:98x10,98x12,98x14,98x16,98x18,98x20,98x22, 98x25, 98x30, shade: BL3, BL4,layer:Multi,Single; dental zirconia 3d-pro,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:C1, C2,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:C3, C4,layer:Multi,Single; dental zirconia 3d-pro,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:C3, C4,layer:Multi,Single; dental zirconia 3d-pro,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: W, A3,A3.5,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:B1, B2,layer:Multi,Single dental zirconia UT, size:98x10,98x12,98x14,98x16,98x18, 98x20, 98x22, 98x25, 98x30, shade:D2, D3,layer:Multi,Single; HENZIR Dental ZIRCONIA 3d-pro, size:98x10, 98x12, 98x14, 98x16, 98x18, 98x20, 98x22, 98x25, 98x30, shade: C1, C2, C3 dental zirconia 3d-pro,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: BL1, BL2,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: C1, C2,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 3d-pro, size:98x10, 98x12, 98x14, 98x16, 98x18,98x20,98x22,98x25,98x30, shade:W,A3,layer:Multi,Single dental zirconia HT, 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:BL3, BL4,layer:Multi,Single dental zirconia 3d-pro, size:98x10, 98x12, 98x14, 98x16, 98x18,98x20,98x22,98x25,98x30, shade:W,A2,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:W, A1, A2,layer:Multi,Single; dental zirconia HT, size:98x10,98x12,98x14,98x16,98x18,98x20,98x22, 98x25, 98x30, shade: C3, C4,layer:Multi,Single; dental zirconia 3d-pro,size:98x10,98x12,98x14,98x16, 98x18, 98x20, 98x22, 98x25, 98x30, shade:BL1, BL2,layer:Multi,Singl 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 UT, size:98x10,98x12,98x14,98x16,98x18, 98x20, 98x22, 98x25, 98x30, shade:W,A4,layer:Multi,Single; dental zirconia 3d-pro,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:W,A1, A2,layer:Multi,Single dental zirconia UT, 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:C1, C2,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:D4,layer:Multi,Single; HENZIR Dental ZIRCONIA 3d-pro, size:98x10, 98x12, 98x14, 98x16, 98x18, 98x20, 98x22, 98x25, 98x30, shade: A3.5, A4, B1 dental zirconia UT, 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:B1, B2,layer:Multi,Single; dental zirconia st-size:98x10, 98x12, 98x14, 98x16, 98x18, 98x20, 98x22, 98x25, 98x30, shade:W,A3,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:D2, D3,layer:Multi,Single; dental zirconia ST+, size:98x10,98x12,98x14,98x16,98x18, 98x20, 98x22, 98x25, 98x30, shade:D4,layer:Multi,Single;

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EJH	Alloy, Metal, Base	Dental	Class 2	872.3710	2017-05-05
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2023-11-19

Official Correspondent

No official correspondent registered.

US Agent Details

Wen Xu Email: infor@believe-med.com Phone: (443) 8968583

Related Public Records

Same Entity

Qinhuangdao Audental Metal Technology Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K810521	C.Vaupel Dental, Inc.	CO-SPAN 13.5 CASTING ALLOY	1981-03-17
K143656	H.C. Starck Ceramics GmbH	StarCeram® Z-Nature, StarCeram® Z-Smile	2015-07-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0017-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse blue, Art. no. 681165 Product Usage: For coloring dental porcelain
Z-0018-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse brown, art. no. 681169 Product Usage: For coloring dental porcelain
Z-0019-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse grey, art. no. 681167 Product Usage: For coloring dental porcelain
Z-0020-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse violet, art. no. 681166 Product Usage: For coloring dental porcelain
Z-0021-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color A1 60ml, art. no. 681050, Product Usage: For coloring dental porcelain

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013546336. Last updated year: 2026. Please use registration number 3013546336 when referencing this establishment in official correspondence.