Shofu Block HC Hard
FDA 510(k) K200470 · Shofu Dental Corporation
510(k) numberK200470
Submission
- Device name
- Shofu Block HC Hard
- Applicant
- Shofu Dental Corporation
San Marcos, CA, US - Received
- February 26, 2020
- Decision date
- February 5, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K251578 | Beautifil IIEBF · Traditional | 05/27/2025SE |
| K233161 | BeautiLink SAEMA · Traditional | 09/28/2023SE |
| K222253 | GlasIonomer FX ULTRAEMA · Traditional | 09/22/2022SE |
| K213965 | BeautiBond XtremeKLE · Traditional | 03/18/2022SE |
| K212939 | Vintage Prime PressEIH · Traditional | 03/18/2022SE |
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Questions and answers
When was Shofu Block HC Hard cleared by the FDA?
Shofu Block HC Hard (K200470) received a 510(k) decision of Substantially Equivalent on February 5, 2021, 345 days after the submission was received.
What is the product code of K200470?
The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.