Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009643402

FEI Number

3009643402

Entity Name

BLOOMDEN BIOCERAMICS (HUNAN) CO.,LTD.

City/State/Country

Changsha Hunan, CN

Establishment Address

No.301, 5th Building, Hi-tech Int'l Enterprise Port, LianDong U Valley, Linyu Rd, Dongfanghong Street, Hi-tech Development Zone, Changsha Hunan 410000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Bloomden Bioceramics (HuNan) Co.,Ltd. (Owner Number: 10083450)

Owner / Operator Contact Address

No.301, 5th Building, Hi-tech Int'l Enterprise Port, LianDong U Valley, Linyu Rd, Dongfanghong Street, Hi-tech Development Zone, Changsha, CN-HN 410000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K260370

PMA Number

N/A

All Registered Proprietary Names

Bloomden, Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank, model: HT-plus, ST, ST-C, ST-ML, SHT, SHT-C Bloomden, Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank, model: SHT-ML, 3D-Pro-ML, UT, UT-C, UT-ML Bloomden, Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank, MOD: STP,STP-C,STP-ML,SHTP,SHTP-C,SHTP-ML Bloomden, Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank, MOD: 3D-Pro-ML, UT, UT-C, UT-ML, HTP-plus Bloomden, Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank, MOD: 3DP-Pro-ML, UTP, UTP-C, UTP-ML Bloomden, Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank, MOD:HT-plus,ST,ST-C,ST-ML,SHT,SHT-C,SHT-ML

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2021-11-21
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2026-04-02

Official Correspondent

Shengyong Liao

US Agent Details

Thomas Tang Business: Shenzhen Joyantech Consulting Co., Ltd. Email: usagent@cefda.com Phone: (631) 7511103

Related Public Records

Same Entity

Bloomden Bioceramics (HuNan) 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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009643402. Last updated year: 2026. Please use registration number 3009643402 when referencing this establishment in official correspondence.