510(k) clearances

Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

Bloomden Bioceramics (HuNan) Co., Ltd. · Dental

K260370Substantially EquivalentTraditionalEIH
Open FDA's page for this record
Third party flag
N
City
Changsha
Advisory committee description
Dental
Address 1
# 301, 5th Bldg., Hi-Tech Int'L Enterprise Port
Address 2
Liandong U Valley, Linyu Rd., Dongfanghong St.
Statement or summary
Summary
Product code
EIH
Zip code
410000
Applicant
Bloomden Bioceramics (HuNan) Co., Ltd.
Decision date
2026-03-30
Decision code
SESE
Country code
CN
Device name
Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
Advisory committee
DE
Contact
Shengyong Liao
K number
K260370
Date received
2026-02-05
Review advisory committee
DE
Postal code
410000
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Powder, Porcelain
Medical specialty description
Dental
Regulation number
872.6660
Device class
2
Registration number
3018252381, 3034729565, 3009496224, 3008754429, 3008347275, 2647456, 3012187973, 9612618, 3003449480, 3008320092, 3018411778, 3004905070, 3004884150, 9614977, 2424472, 3009081830, 3007160911, 3040605150, 3039433962, 3004362235, 3030621102, 2082832, 3019784699, 3014945384, 3027481489, 1718912, 9611385, 3013551048, 3030536692, 1420089, 3013342350, 3002889488, 3038715999, 3000219976, 3027341558, 1410097, 3003310824, 3004966444, 3013513796, 3013376795 +122 more
FEI number
3018252381, 3034729565, 3009496224, 3008754429, 3008347275, 4838, 3012187973, 2647456, 3003449480, 3008320092, 3018411778, 3004905070, 3004884150, 3009081830, 3007160911, 3040605150, 3039433962, 3004362235, 3030621102, 3003719498, 2082832, 3019784699, 3014945384, 3027481489, 1718912, 3004975279, 3013551048, 3030536692, 1420089, 3013342350, 3002889488, 3002806930, 3038715999, 3000219976, 1000120733, 3027341558, 1410097, 3009523116, 3003310824, 3004966444 +122 more
Wholesale access for licensed clinicians.

Free to join: your NPI is checked against the federal registry at signup, then wholesale pricing and the professional shelves open.

Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.