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510(k) K212765

Device
Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
Applicant
Bloomden Bioceramics (HuNan) Co., Ltd.
510(k) number
K212765
Product code
EIH
Decision
Substantially Equivalent (SESE)
Decision date
2021-11-15
Date received
2021-08-31
Regulation
872.6660
Classification name
Powder, Porcelain
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Shengyong Liao
Address
#301, 5th Bldg., Hi-Tech Int'L Enterprise Port Liandong U Valley, Linyu Rd. Changsha CN 410000 410000

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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