Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006110126

FEI Number

3006110126

Entity Name

COHO Advanced Materials Tech. Co., Ltd.

City/State/Country

Luzhu District Taoyuan, TW

Establishment Address

21 Dafeng Street, Luzhu District Taoyuan 33860, TW

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Coho Biomedical Technology Co, Ltd (Owner Number: 10034334)

Owner / Operator Contact Address

21 Dafeng Street, Luzhu District, TW-TAO 33860, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

"COHO" Orthodontic appliance and accessories

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2015-06-24
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2016-08-03
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2014-06-17
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2014-06-17
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	2022-12-30
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2013-01-14

Official Correspondent

Vicky Kuo

US Agent Details

Claudia Wen Email: usagent.claudiawen@gmail.com Phone: (626) 5890926

Related Public Records

Same Entity

Coho Biomedical 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
K143656	H.C. Starck Ceramics GmbH	StarCeram® Z-Nature, StarCeram® Z-Smile	2015-07-09
K081806	Idi Biomedical, LLC	IDI IMPLANT SYSTEM	2008-11-07
K120793	Z-Systems AG	Z-LOOK3 EVO SLM	2012-12-21
K130140	Intra-Lock International	INTRA-LOCK OP DENTAL IMPLANT	2013-08-01
K925778	Nobelpharma USA, Inc.	BRANEMARK SYSTEM LAB. AND EDUCATIONAL ACCESSORIES	1993-04-14

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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3031595584	ZHEJIANG ZAHNDENT BIOTECHNOLOGY CO.,LTD	Taizhou Zhejiang, CN
3030464310	DOCTUS GLOBAL	Goyang-si, Gyeonggi-do, KR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006110126. Last updated year: 2026. Please use registration number 3006110126 when referencing this establishment in official correspondence.