FDA.report

510(k) K240672

Device
Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank ( ZD-HT-PLUS, ZD-ST, ZD-SHT, ZD-HT-C, ZD-ST-C, ZD-SHT-C, ZD-UT-C, ZD-ST-ML, ZD-SHT-ML, ZD-UT-ML, ZD-3D-Pro-ML, ZD-4D-Pro-ML)
Applicant
Zhejiang Zahndent Biotechnology Co., Ltd.
510(k) number
K240672
Product code
EIH
Decision
Substantially Equivalent (SESE)
Decision date
2024-06-07
Date received
2024-03-11
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

Related Records

Applicant Contact

Contact
Yaping Huang
Address
#203, Bldg. 8, Lecheng Industrial Park, Xinqian Huangyan District Taizhou CN 318020 318020

FDA Registration Numbers

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DIBrandCompanyPublished
16977667920129Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank ZHEJIANG ZAHNDENT BIOTECHNOLOGY CO.,LTD2024-07-27
16977667920112Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank ZHEJIANG ZAHNDENT BIOTECHNOLOGY CO.,LTD2024-07-27
16977667920105Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank ZHEJIANG ZAHNDENT BIOTECHNOLOGY CO.,LTD2024-07-27
16977667920099Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank ZHEJIANG ZAHNDENT BIOTECHNOLOGY CO.,LTD2024-07-27
16977667920082Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank ZHEJIANG ZAHNDENT BIOTECHNOLOGY CO.,LTD2024-07-27
16977667920075Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank ZHEJIANG ZAHNDENT BIOTECHNOLOGY CO.,LTD2024-07-27
16977667920068Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank ZHEJIANG ZAHNDENT BIOTECHNOLOGY CO.,LTD2024-07-27
16977667920051Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank ZHEJIANG ZAHNDENT BIOTECHNOLOGY CO.,LTD2024-07-27
16977667920044Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank ZHEJIANG ZAHNDENT BIOTECHNOLOGY CO.,LTD2024-07-27
16977667920037Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank ZHEJIANG ZAHNDENT BIOTECHNOLOGY CO.,LTD2024-07-27
16977667920020Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank ZHEJIANG ZAHNDENT BIOTECHNOLOGY CO.,LTD2024-07-27
16977667920013Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank ZHEJIANG ZAHNDENT BIOTECHNOLOGY CO.,LTD2024-07-27

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