Vintage Art Universal
FDA 510(k) K191794 · Shofu Dental Corporation
510(k) numberK191794
Submission
- Device name
- Vintage Art Universal
- Applicant
- Shofu Dental Corporation
San Marcos, CA, US - Received
- July 3, 2019
- Decision date
- October 3, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K262195 | Dandy Ceramic Stain and GlazeEIH · Traditional | Zima International Inc., dba Dandy | 06/30/2026SE |
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| K260067 | Eternal Art Porcelain PowdersEIH · Traditional | Shandong Huge Dental Material Corporation | 04/09/2026SE |
| K260370 | Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankEIH · Traditional | Bloomden Bioceramics (HuNan) Co., Ltd. | 03/30/2026SE |
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| K222253 | GlasIonomer FX ULTRAEMA · Traditional | 09/22/2022SE |
| K213965 | BeautiBond XtremeKLE · Traditional | 03/18/2022SE |
| K212939 | Vintage Prime PressEIH · Traditional | 03/18/2022SE |
| K200470 | Shofu Block HC HardEBF · Traditional | 02/05/2021SE |
| K182869 | Fit SAEBF · Traditional | 01/09/2019SE |
Questions and answers
When was Vintage Art Universal cleared by the FDA?
Vintage Art Universal (K191794) received a 510(k) decision of Substantially Equivalent on October 3, 2019, 92 days after the submission was received.
What is the product code of K191794?
The FDA product code is EIH – Powder, Porcelain, a Class II (moderate risk) device regulated under 21 CFR 872.6660.