MAZIC Claro CAD and MAZIC Claro Press
FDA 510(k) K203672 · Vericom Co., Ltd.
510(k) numberK203672
Submission
- Device name
- MAZIC Claro CAD and MAZIC Claro Press
- Applicant
- Vericom Co., Ltd.
Chuncheon-Si, KR - Received
- December 16, 2020
- Decision date
- July 1, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was MAZIC Claro CAD and MAZIC Claro Press cleared by the FDA?
MAZIC Claro CAD and MAZIC Claro Press (K203672) received a 510(k) decision of Substantially Equivalent on July 1, 2021, 197 days after the submission was received.
What is the product code of K203672?
The FDA product code is EIH – Powder, Porcelain, a Class II (moderate risk) device regulated under 21 CFR 872.6660.