Impression Material— 510(k) K201483
Substantially EquivalentZhengzhou Huaer Electro Optics Technology Co., Ltd.
FDA 510(k) clearance K201483 for Impression Material, Substantially Equivalent on 2020-10-08. Applicant: Zhengzhou Huaer Electro Optics Technology Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Zhengzhou Huaer Electro Optics Technology Co., Ltd.
- Product code
- Code ELW
- Device class
- Class 2
- Regulation
- 21 CFR 872.3660
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Zhengzhou, CN
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Data sourced from openFDA. This site is unofficial and independent of the FDA.