Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010564008

FEI Number

3010564008

Entity Name

DENKEN-HIGHDENTAL Co., Ltd.

City/State/Country

Kyoto, JP

Establishment Address

24-3 Kisshoin Ishiharakyomichi-Cho, Minami-ku, Kyoto 601-8356, JP

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

DENKEN-HIGHDENTAL Co., Ltd. (Owner Number: 10045737)

Owner / Operator Contact Address

24-3 Kisshoin Ishiharakyomichi-cho, Minami-ku, Kyoto, JP-26 601-8356, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K221429

PMA Number

N/A

All Registered Proprietary Names

KDF Zirconia Disc

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2023-04-28

Official Correspondent

No official correspondent registered.

US Agent Details

David FURR Business: FDC Services LLC Email: davidfurr@fdcservices.com Phone: (512) 9069654

Related Public Records

Same Entity

DENKEN-HIGHDENTAL 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

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

Similar Registrations

Registration Number	Establishment Name	Location
3013513796	Orbray Co., Ltd.	Yokote-shi Akita, JP
3034729999	LIAONING RACHCERA MATERIAL TECHNOLOGY CO.,LTD.	Shenyang Liaoning, CN
3021284321	ZIRDENT NEW MATERIAL CO.,LTD	Changsha Hunan, CN
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 3010564008. Last updated year: 2026. Please use registration number 3010564008 when referencing this establishment in official correspondence.